TIDMEKF

RNS Number : 3098G

EKF Diagnostics Holdings PLC

29 March 2022

This announcement contains inside information

for the purposes of Article 7 of Regulation (EU) No 596/2014 as it forms part of UK law

by virtue of the European Union (Withdrawal) Act 2018 ("MAR")

EKF Diagnostics Holdings plc

("EKF", the "Company" or the "Group")

Final results

EKF Diagnostics Holdings plc (AIM: EKF), the AIM-listed global diagnostics business, announces its final results for the year ended 31 December 2021. Comparative data is provided for the year ended 31 December 2020, unless otherwise indicated.

Financial Highlights

   --       Revenue up 25% to GBP81.8m (2020: GBP65.3m) 
   -    Core(1) business revenues up 14% to GBP42.1m (2020: GBP37.1m) 
   --       Gross profit up 5% to GBP39.4m (2020: GBP37.4m) 

-- Adjusted EBITDA(2) up 4% to GBP26.5m (2020: GBP25.5m), reflecting the changes in the mix of Contract Manufacturing related products as well as increased costs in the supply chain.

   --       Profit before tax of GBP21.4m (2020: GBP15.4m), including effect of share-based payments 
   --       Basic earnings per share of 3.47p (2020: 2.45p) 
   --       Cash generated by operating activities of GBP10.2m (2020: GBP13.8m) 

-- Cash at 31 December 2021 of GBP20.3m (2020: GBP21.9m), net cash after borrowings of GBP19.6m (2020: GBP21.4m)

   --       Value of investments in marketable securities at year end of GBP7.6m (2020: GBP6.5m) 

-- Cash dividend of GBP5.1m paid to shareholders, equivalent to 1.1p per ordinary share (2020: 1.0p per share)

Operational Highlights

-- Focus on returning core business to pre-pandemic 2019 levels and positioned for future sustainable growth outside of short-term contract manufacturing

   --     New reporting of business division revenues: 
   -    Point-of-Care - up 18% to GBP27.0m 
   -    Central Laboratory - up 7% to GBP13.1m 
   -    Life Sciences - up 3% to GBP2.0m 

- Contract Manufacturing - up 38% to GBP36.3m, driven by COVID sample collection kits manufacture

- Laboratory Testing Services - ADL Health contributed GBP1.0m following acquisition in September 2021

-- Significant investment in South Bend, Indiana, facility to expand EKF Life Sciences' fermentation capabilities

-- $10m acquisition of ADL Health, an earnings enhancing and cash generative CLIA certified testing laboratory

(1) Core business includes Point of Care, Central Laboratory and Life Sciences

(2) Earnings before interest, tax, depreciation and amortisation, share-based payments and exceptional items, as laid out in the income statement

Christopher Mills, Non-Executive Chairman of EKF, commented:

"2021 was a year that delivered record revenue and adjusted EBITDA performance. Our key focus remains on implementing our strategy to position our core business for sustainable future growth, utilising cash generated from short-term contract manufacturing activities. At the end of 2019, and pre-pandemic, we had a core business that generated revenues of GBP43.3m and an adjusted EBITDA of GBP12m. These results show that in 2021 our core business revenues were broadly in-line with these levels and we have already implemented our investment plans to support growth in our core business in 2022.

"Current trading is strong and we expect to deliver a solid first quarter performance in line with that of 2021. However, we are adopting a pragmatic view that we expect there will be a significant reduction in pandemic-related contract manufacturing activity for the remainder of the year and guiding analysts accordingly. The new management team is keenly focused on delivering the growth plan through to 2024 which assumes no benefit from further COVID-related manufacturing, but instead is targeting sustainable revenue growth in our expanded core operations."

 
     EKF Diagnostics Holdings plc                                         www.ekfdiagnostics.com 
     Christopher Mills, Non-Executive Chairman                          Tel: +44 (0)29 2071 0570 
     Mike Salter, CEO 
     Marc Davies, CFO 
 
     Singer Capital Markets (Nominated Adviser &                       Tel: +44 ( 0)20 7496 3000 
      Joint Broker) 
     Aubrey Powell / George Tzimas / Tom 
      Salvesen 
 
     Investec Bank plc (Joint Broker)                                   Tel: +44 (0)20 7597 4000 
     Gary Clarence / Daniel Adams / Ben 
      Farrow 
 
     Walbrook PR Limited                          Tel: +44 (0)20 7933 8780 or ekf@walbrookpr.com 
     Paul McManus / Lianne Applegarth                 Mob: +44 (0)7980 541 893 / +44 (0)7584 391 
                                                                                             303 
 
 

About EKF Diagnostics Holdings plc (www.ekfdiagnostics.com)

EKF is a leading global diagnostics business with custom manufacturing facilities across sites in the US, UK and Europe for a variety of life science products. EKF is focussed on the following areas:

 
     Point-of-Care                Providing a portfolio of Point-of-Care analysers and 
                                   consumables, particularly for use in the area of Hematology 
                                   and Diabetes, for use in hospital and research laboratories, 
                                   doctor's offices, blood banks and for in-field anaemia 
                                   screening programmes. EKF has an estimated 80,000 
                                   hemoglobin, hematocrit, HbA1c, glucose and lactate 
                                   analysers in regular use across more than 100 countries. 
     Central Laboratory           Clinical chemistry, Small lab analysers, Centrifuges 
                                   Beta-Hydroxybutyrate (<BETA>-HB) LiquiColor, Glycates 
                                   Albumin, Glycated Serum Protein, Nitro-tab, Procalcitonin 
     Life Sciences                Enzyme fermentation, Custom products and Bulk fermentation 
     Contract Manufacturing       Bulk formulation, Sample collection kits, Private 
                                   labelling, Molecular and forensic kits 
     Laboratory Services          In September 2021, EKF completed the acquisition of 
                                   Advanced Diagnostic Laboratory LLC ("ADL Health"), 
                                   a Texas based testing laboratory certified under the 
                                   Clinical Laboratory Improvement Amendments ("CLIA") 
                                   for high complexity testing. The laboratory provides 
                                   testing for a variety of clinical, forensic and microbiological 
                                   sample types using a range of analytical techniques. 
                                   This acquisition positions EKF as a leading 'one stop' 
                                   provider of diagnostic products and services from 
                                   sample collection to results. 
 

In May 2021, EKF announced its strategy for delivering growth to 2024 and beyond, and continuing to deliver shareholder value. The strategy for growth can be summarised as:

 
     --       continuing innovation in products and services in Point-of-Care, 
               Central Laboratory and Life Sciences leveraging new and existing 
               routes to market and relationships; 
     --       investment in expanded production and kitting capabilities to offer 
               a suite of diagnostic Contract Manufacturing solutions to third 
               party businesses; 
     --       expansion of CLIA Laboratories Testing offering, building on the 
               acquired capabilities in ADL Health; and 
     --       identify complementary earnings-enhancing acquisitions with key 
               strategic value. 
 

EKF will also continue to generate enhanced shareholder value through:

 
     --       a progressive dividend policy; and 
     --       its agreement with Mount Sinai Innovation Partners ("MSIP"), which 
               allows us advanced access to innovative commercial opportunities 
               and where we can build on the ongoing successes of Renalytix plc, 
               Verici Dx plc and Trellus Health plc. 
 

Chairman's Statement

2021 has been another record-breaking year for EKF, with revenue increasing by 25% to GBP81.8m (2020: GBP65.3m), and core business revenues returning to pre-pandemic levels. We have delivered another strong earnings performance with GBP26.5m of adjusted EBITDA generated in the year (2020: GBP25.5m) and basic earnings per share having improved materially at 3.47p per share (2020: 2.45p). Cash levels remain strong with net cash after borrowings of GBP19.6m (2020: GBP21.4m), despite considerable investment (GBP5.6m compared with 2020: GBP2.1m) to drive the future growth of the business and shareholder value generation outside of COVID-related contract manufacturing revenues.

The story of 2021 has been one of expansion, including laying the foundations for further growth: building on our successes in 2020; building on the capabilities that we developed in response to COVID and readying them to be applied to new areas; building new facilities and structures to support a return to growth across our core business; and building a new leadership team to drive the business forward.

It is our current view that COVID-related revenues from contract manufacturing will materially reduce in 2022, given the rapid step-back in testing requirements across global markets. COVID-related revenues were always going to be of indeterminate duration and quantity, so our focus and strategy have already turned to positioning the business to deliver growth across all core business areas, whilst redirecting the capabilities developed for COVID into other activities. We are delighted to report that in 2021 every single product group delivered year-on-year growth and the expansion of contract development and manufacture of diagnostic test kits, along with the laboratory acquisition in the United States, positions us well for capturing further work in other healthcare applications.

The short-term benefits derived from our COVID-related contract manufacturing success has allowed the Group to fuel growth by investing in facilities and equipment for the future, as well as the acquisition of a new business in an area which not only widens our offering but also brings synergy potential by adding to the relationships and abilities we have gained over the last two years. We remain confident in our strategy for growth to 2024 and we believe that the core business alone has the potential to deliver significant revenue growth without reliance on COVID in that timescale and we are focussed on developing a sustainable business that can deliver EBITDA growth over the next three years.

Growth strategy

In May last year, we announced our strategy for delivering growth to 2024 and beyond, and continuing to deliver shareholder value. The strategy for growth has been updated and can be summarised as:

-- continuing innovation in products and services in Point-of-Care, Central Laboratory and Life Sciences leveraging new and existing routes to market and relationships;

-- investment in expanded production and kitting capabilities to offer a suite of diagnostic Contract Manufacturing solutions to third party businesses;

-- expansion of CLIA Laboratories Testing offering building on the acquired capabilities in ADL Health; and

   --    identify complementary earnings-enhancing acquisitions with key strategic value. 

We also believe we can continue to generate enhanced shareholder value through:

   --    a progressive dividend policy; and 

-- our agreement with Mount Sinai Innovation Partners ("MSIP"), which allows us advanced access to innovative commercial opportunities and where we can build on the ongoing successes of Renalytix plc, Verici Dx plc and Trellus Health.

The operational performance of our business, and the COVID-related contract manufacturing business, are outlined in the Chief Executive's Statement. This also focusses on the progress we have made in positioning the business for growth and the execution of that strategy, including our recent acquisition in the laboratory testing space.

MSIP Preferred Partnership Agreement and related activities

Our Preferred Partnership Agreement, signed with MSIP in 2019, provides us with advanced access to innovative commercial opportunities arising from Mount Sinai Health System owned technologies in the field of healthcare technologies. This partnership has already led to the development of three new businesses, all of which are listed on AIM, with Renalytix plc shares also trading on Nasdaq as RNLX:

-- Renalytix plc (AIM: RENX), the developer of artificial intelligence-enabled diagnostics for kidney disease;

-- Verici Dx plc (AIM: VRCI), a developer of advanced clinical diagnostics for organ transplant; and

-- Trellus Health plc (AIM: TRLS), a resilience-drive healthcare company working to transform the way complex chronic conditions are treated through whole-patient care, with an initial focus on Inflammatory Bowel Disease (IBD).

Trellus Health plc's IPO was completed in May 2021, with EKF's retained voting rights being transferred to shareholders. Based on the IPO issue price of 40p this transfer represented a distribution of GBP11.2m to EKF shareholders. The value of our remaining holding in Renalytix plc (1.39%) was worth GBP6.2m at 31 December 2021 (2020: GBP4.9m).

Our initial holding in Verici Dx plc ("Verici"), which we received by way of a dividend from Renalytix plc during 2020, was worth GBP1.4m (2020: GBP1.5m) at year end. On 7 March 2022, we announced that we had agreed to invest a further GBP2.5m by participating in Verici's secondary fundraising. This additional funding round will accelerate the progress Verici has already made to date towards commercial launch of its two lead products, as well as the development of its third product and expansion of other capabilities. Following this funding exercise we currently own 5.77% of Verici's enlarged share capital. It remains our stated intention to distribute this enlarged holding to underlying shareholders as soon as reasonably practicable and subject to appropriate arrangements to maintain an orderly market in Verici's shares following such distribution.

We will continue to consider additional investment in the existing stable of spin-outs and to explore other opportunities with MSIP and will update shareholders should any of these prospects become candidates with the potential to deliver further value to our investors.

Dividend

In December 2021, the Company paid a cash dividend of 1.1p (2020: 1.0p) per share as a final dividend for 2020, a total pay-out of GBP5.1m (2020: GBP4.6m). We are pleased to confirm that, given the progress in EKF's business and its strong cash generation, we intend to make a further dividend payment to shareholders of 1.2p per ordinary share in respect of the performance of the business in 2021. If approved by shareholders at the Company's next Annual General Meeting, payment will be on 1 December 2022.

Share capital

During the year to 31 December 2021, we did not utilise the permission we obtained from shareholders to make on-market purchases of shares for cancellation or otherwise. The Board will subsequently today announce plans to undertake a targeted exercise to buy back up to a maximum of 9,000,000 shares (subject to a maximum spend of approximately GBP4.0 million) and we believe this is an appropriate use of our cash reserves and an effective means of further improving shareholder value (the "Buyback").

The purpose of the Buyback is to return cash to shareholders and to reduce the share capital of the Company. The Buyback will be funded from the Company's existing surplus cash resources and all ordinary shares of 1p each in the capital of the Company (the "Ordinary Shares"), purchased will be held in treasury. Any repurchases made following the Company's next AGM being held on 18 May 2022 will be conditional upon a further shareholder approval of the Company's general buyback authority being obtained at that meeting and subject to the limit of 69,589,585 Ordinary Shares, or such other number as would represent approximately 15 per cent of the Company's issued share capital at the time of issue of notice of the 2022 AGM. The Company currently intends to operate the Buyback from the date of this announcement until the earlier of:- the date on which purchase of 9,000,000 Ordinary Shares has been completed; the date of the 2022 Annual General Meeting in the event further shareholder approval is not obtained; or 31 December 2022.

Board changes

It has been a year of significant change at Board level in EKF, we believe we have a newly focussed Executive team with an excellent track record for delivering and managing substantial growth in the Lifesciences and Healthcare sector, as well an experienced and complementary non-executive team to provide appropriate challenge and support to them as they execute our growth strategy into 2024.

Mike Salter, Chief Executive Officer

Mike Salter, who led our US operations since joining EKF in October 2017 and has been instrumental in delivering much of the growth we have seen in this region, became Chief Executive Officer on 1 October 2021. Mike is an organic Chemist by training, and based in San Antonio, Texas and previously headed up our Americas business. Mike was responsible for overseeing the growth of our Diabetes and Haematology business in the US and, by leveraging his business network, he secured licensing agreements, built production capacity and signed orders for our COVID-19 sample collection kit business. Mike has been a passionate leader of our US team and has been instrumental in securing many of our largest US contracts and growth opportunities and was selected as the ideal candidate to deliver our strategy of accelerated organic growth.

Mike has over 35 years of experience in the Life Science and Diagnostics Industry. He joined Amersham plc, the UK's largest Life Science company, in 1984 and spent 20 years in various Operational, Product Management and Business Development roles. When Amersham was acquired by GE in 2004 to become GE Healthcare, Mike moved into senior commercial and business development roles leading new strategic Diagnostic initiatives. In 2016, Mike became General Manager of the Global Custom Genomics Business. Throughout his time at GE Healthcare, Mike managed a successful multi-million dollar business providing Biotech and Lifesciences companies with products and services to support the development and launch of their new products. At EKF in his role as President, Americas, Mike was responsible for delivering over $20m of new contract manufacturing revenues from the US operations.

Marc Davies, Chief Financial Officer

Marc Davies, joined as Chief Financial Officer on 1 January 2022, having moved on from his role as Group Finance and Operations Director at Flexicare Medical ("Flexicare") , a medical device designer, manufacturer and supplier. At Flexicare Marc was responsible for overseeing a period of substantial revenue growth, driven by both organic performance and acquisition. During his five years at Flexicare, Marc led several corporate finance transactions including post-transaction integration.

Previously, Marc was a Corporate Finance Director at PwC, providing mid-market private business and private equity focused corporate finance advice as Head of the PwC West and Wales Corporate Finance Team. Before joining PwC in February 2013, Marc was an AIM focussed Corporate Finance Adviser for over five years, during which he spent four years at WH Ireland, including work within its Nominated Adviser function. Marc began his career in finance as part of the PwC Corporate Recovery team. Marc is a Fellow Chartered Accountant (FCA) and an Oxford graduate with an MSc in Mathematical Modelling and Scientific Computation and an MA in Mathematical Science .

Mike and Marc replaced Julian Baines, MBE, co-founder of EKF in its present form, and Richard Evans respectively. We cannot thank Julian enough for his leadership and hard work on behalf of EKF's shareholders over the previous 12 years. He remains on the Board as Non-Executive Deputy Chair. Our thanks also go to Richard for the guidance he has given the Board and the Group over the significant time he has spent with us.

We also welcomed two new Non-executive Directors: Christian (Chris) Rigg, a chartered accountant with experience in listed businesses at Chief Executive Officer, Chief Financial Officer and Non-executive Director level, and Jenny Winter, currently Chief Executive of Animalcare Group plc, an AIM listed animal healthcare group.

Our thanks also go to the Non-executive Directors who have retired through the year. Adam Reynolds was a Director of the business in its previous guise as a sports products company, and has provided sage advice over the long term since the EKF business reversed into International Brands plc as it was then known. Carl Contadini has served on the Board since 2016 and offered invaluable input to the operations of the business throughout that time. We thank them both for their valued contributions.

The Board now comprises six members - two Executive Directors and four Non-executive Directors:

   --    Mike Salter, Chief Executive Officer 
   --    Marc Davies, Chief Financial Officer 
   --    Christopher Mills, Non-executive Chairman 
   --    Julian Baines, Deputy Non-executive Deputy Chairman 
   --    Christian Rigg, Senior Independent Non-executive Director 
   --    Jenny Winter, Independent Non-executive Director 

We believe that Executive and Non-executive Directors have the right mix of skills and expertise to lead our excellent team around the World to attain our objectives for continuing success.

The Board believes that the revised make-up of the Board is appropriate. We have adopted the Corporate Governance Code issued by the Quoted Company Alliance. Further details of compliance are found in the Corporate Governance Statement and on the Company's website.

Cash-settled share-based incentive

The Company has for some years operated a cash-settled, share price based incentive for its executive directors (the "Incentive"), designed to pay out in the event that the Company was acquired by a third party (an "Exit"). During the present year EKF shareholders have benefited from very strong increases in value through the improved performance of the Group and the investment opportunities that we have followed. Reflecting this continued delivery of value to shareholders by the Executive Directors, EKF's Remuneration Committee determined that, in the absence of any other performance related pay mechanism, it was appropriate to distribute, as performance-related pay, a portion of the amount that would otherwise be payable under the Incentive on an Exit. The Executive Directors each received an equal payment of GBP0.5m million in January 2021, followed by a final equal payment of GBP2.0m each in July 2021. After these payments, the original scheme was terminated, as was the similar scheme for Mr Salter, from which no payments were made. As a result of the terminations, the fair value amount accrued but unpaid relating to the schemes totalling GBP1.9m was written back through the income statement.

In September 2021 Mr Salter was granted a replacement cash settled share-based incentive award. The new award vests if a controlling interest in the Company is acquired by a third party at any time. In these circumstances an award is payable to Mr Salter, which increases by reference to the sale price achieved. It is anticipated that this scheme will be extended to include Mr Davies in due course.

Outlook

2021 was a year that delivered record revenue and adjusted EBITDA performance. Our key focus remains on implementing our strategy to position our core business for sustainable future growth, utilising cash generated from short-term contract manufacturing activities. At the end of 2019 and pre-pandemic we had a core business that generated revenues of GBP43.3m and an adjusted EBITDA of GBP12.0m. The results for 2021 show that our core business revenues were broadly in-line with these levels and we have already implemented our investment plans to support growth in our core business in 2022.

We are particularly excited about the prospect of our recent acquisition in the laboratory testing space. Not only is this earning enhancing and cash generative, but also an excellent strategic fit within our existing diagnostics offering that will strengthen our offering to our customer base. The investment in additional fermentation will also drive organic growth as our larger volume enzyme production capacity comes on-line this year.

Current trading is strong and we expect to deliver a solid first quarter performance in line with that of 2021. However, we are adopting a pragmatic view that there will be a significant reduction in pandemic-related contract manufacturing activity for the remainder of the year. The new management team is keenly focused on delivering the growth plan through to 2024 which assumes no benefit from further COVID-related manufacturing, but instead is targeting sustainable revenue growth in our expanded core operations.

Christopher Mills

Non-Executive Chairman

29 March 2022

Chief Executive Officer Review

I am delighted that we have delivered record results for 2021, with significant year-on-year revenue growth (up 25% from GBP65.3m in 2020 to GBP81.8m).

I am also proud that the team was again able to rapidly react and support the growing need for sample collection devices, kits and sample media to support the testing needs triggered by the global pandemic.

A significant proportion of EKF's top line growth in 2021 has come from COVID-related contract manufacturing, which is an area of the business that we anticipate will reduce in prominence as the world begins to 'live with COVID' and governments significantly reduce their ongoing testing requirements. However, we have now positioned ourselves as a leading provider of products and services to support any future testing demand whether COVID related or other public health requirement.

More significant for the outlook for the business is the fact that, during 2021, revenues from our core business increased 14% to GBP42.1m (2020: GBP37.1m) with growth across all key product verticals. These business revenue levels also see us broadly in-line with pre-pandemic revenue levels as seen in 2019 and the core business represents a compelling platform in its own right. Having focussed on recovering the existing core business to previous levels, we believe this progress, coupled with investments already made, and additional future investments, will fuel sustainable growth across our business.

Operational overview

As a new management team, we have taken the opportunity to recalibrate how we report revenues going forward to more closely align with our product groups and the way in which business divisions report into senior management.

These are shown below:

 
     Key products/services 
------------------------------------  ------------------------------------------------------- 
          Point-of-Care                    Hematology: 
           Providing a portfolio of         Hemo Control, DiaSpect Tm, HemataStat II, 
           analyser and consumables,        Ultracrit 
           particularly for use in          Diabetes : 
           Hematology and Diabetes          Biosen C-Line, Quo-Lab A1c, Quo-Test A1c, 
                                            STAT-Site WB) 
                                            Other: 
                                            Creamatocrit Plus, Pregnancy Tests, Lactate 
                                            Scout, Uri-Trak 
------------------------------------  ------------------------------------------------------- 
     Clinical chemistry                     Beta-Hydroxybutyrate (<BETA>-HB) LiquiColor, 
      Clinical chemistry, Small              Glycates Albumin, 
      lab analysers, Centrifuges             Glycated Serum Protein, Nitro-tab, Procalcitonin 
     Life Sciences                         Enzyme fermentation, Custom products and 
                                            Bulk fermentation 
     Contract Manufacturing                Bulk formulation, Sample collection kits, 
                                            Private labelling, Molecular and forensic 
                                            kits 
------------------------------------  ------------------------------------------------------- 
     Laboratory Services                   Following the acquisition of Advanced Diagnostic 
                                            Laboratory LLC ("ADL Health") CLIA certified 
                                            facility 
------------------------------------  ------------------------------------------------------- 
 
 
     Division                           2021           2020 
      GBP millions                   Revenue        Revenue 
----------------------------   -------------  ------------- 
     Point-of-Care                      27.0           22.9 
     Central Laboratory                 13.1           12.2 
     Life Sciences                       2.0            2.0 
     Contract Manufacturing             36.3           26.3 
     Laboratory Services*                1.0              - 
-----------------------------  -------------  ------------- 
 

*contribution from 27 September 2021

Point-of-Care

Sales of our hemoglobin analyzers Hemo Control and DiaSpect Tm showed strong growth as blood banks and anaemia programmes came back online. Our HemataStat product, meanwhile, showed significant growth of 29% as we see a return to normality. We have also seen growth across all our diabetes instrument ranges, with revenues overall increasing by 13%, driven by high growth from our Quo-Test product line.

Professional sports medicine has been returning to normal as shown by a 27% increase in Lactate Scout revenues. We have continued development work for our clinically focussed Response product.

For 2022, we are looking forward to healthcare and customer development programmes returning to normal.

Central Laboratory

<BETA>-HB LiquiColor sales remain strong and increased by 8% contributing the majority of growth in this area, with sales of other chemistry products broadly flat, due to customers concentrating on COVID-related business revenues. We now expect these to come back on stream during the course of 2022.

Life Sciences

Across contract fermentation and other non-COVID related contract manufacturing, sales remained flat at GBP2.0m. We continue to see a strong pipeline of opportunities to supply contract manufacturing services from our Elkhart and South Bend sites, in Indiana, and have committed resources to add capacity.

To take advantage of a demand-driven opportunity in the research and molecular enzyme areas, as well as food grade fermentation digestive proteins area, we are investing around $10m in the construction and installation of new 1,500L, 3,000L and 14,000L fermenters by third party, specialist turn-key contractors. We expect this to support significant revenues growth in this area by 2024.

Contract Manufacturing

Once again, the majority of our contract manufacturing revenues related to supporting testing requirements in relation to the Global Pandemic. The market dynamics for COVID test collection kits changed during 2021 and to meet demand our focus switched from sales of reagents for molecular transport media, which had characterised our activities in 2020, to the manufacture of filled tubes and sample collection kits. While the revenues from these product lines increased significantly, the nature of these products meant that the gross margin percentages were lower. As governments across the world changed their responses to COVID, often at very short notice, we and our customers were required to be extremely flexible to vary activity levels in response to demand which often changed overnight.

Our sample collection related revenues at the beginning of the current year have held up well, however we expect to see this specific revenue line significantly decrease over the year as the demand for testing drops. We have continued to use temporary workers and to add facilities on short term bases where possible to limit our risk. We have developed excellent transferable and scalable skills as a result of our pandemic response, and we are looking forward to applying these skills to new areas. We have identified a number of potential opportunities through partners which we believe have great potential going forward and are working hard to bring these to fruition.

Upon review of COVID related stock at year end we have increased our overall inventory provision by a further GBP384k. We believe this is prudent given the anticipated decrease in COVID related activities.

Laboratory Services

On 27 September 2021, we acquired ADL Health, a San Antonio based CLIA certified testing laboratory focussed on high complexity testing and covering the fields of clinical, forensic and microbiological tests. Using its expertise in Polymerase Chain Reaction (PCR) testing, ADL Health also provides COVID testing needs for dozens of Fortune 500 companies and government agencies. ADL Health is expanding its range of testing capabilities across a broader suite of healthcare applications.

The cost of acquisition of ADL was an initial $10m largely funded through the issue of ordinary EKF shares after a working capital true-up payable in cash, with the consideration shares subject to a phased lock-in and orderly market agreement, plus contingent consideration based on the achievement of certain earnings targets over the following three years. The ADL Health business is cash generative and is expected to have a strong first quarter significantly exceeding revenues recorded in the final quarter of 2021.

The EKF Board believes that ADL Health's wider testing offer, including current and planned capabilities, provides an attractive platform to both complement and broaden the Group's existing diagnostics offering. Having CLIA lab capacity in-house also provides us with a means to strengthen our customer relationships by providing wider testing services, and allows us to build synergistically on the relationships with industry leaders that we have developed over the last two years.

Since the acquisition, we have already secured a strategic partnership with our existing customer, Yourgene Health plc, whereby ADL Health will offer a non-invasive pre-natal testing (NIPT) service to the US market, utilising Yourgene's proprietary technology and ADL Health's accredited US laboratory to process returned samples.

ADL Health contributed GBP1.0m to 2021 revenues, following its acquisition on 27 September 2021.

In addition to the above business divisions there was a further GBP2.4m revenues related to shipping and handling recharges, repairs and other sundries (2020: GBP1.9m).

Regulatory update

Our regulatory team is fully committed to meet the new requirements of the In Vitro Diagnostic Regulation (IVDR) which affects all our products in the EU. We have adapted to the significant changes the IVDR bring such that we are ready to meet the immediate requirements in May 2022, and have a defined plan for the amended transitional provisions as published in January. For the UK, to meet the requirements of the MHRA we have established the UK Responsible Person for our non-UK operating entities, and are set to meet UKCA marking requirements.

Russia and Ukraine

EKF owns 60% of O.O.O. EKF Diagnostika, a distribution subsidiary located in Moscow which sells EKF Point-of-Care products and other third-party products into Russia and neighbouring states. As a supplier of medical products with no dual use it would not be appropriate to end supplies to the region, but we are seeing some disruption caused by the Western sanctions relating to foreign exchange controls. We are working with the staff and management of this business to keep it as stable as possible, but we have already discounted sales from this region from our growth forecasts as a precaution. Financial details of our business in Russia, which represents less than 5% of Group revenue and Adjusted EBITDA at the consolidated level, are shown in the segmental analysis in Note 3.

We also have a distributor in Ukraine with whom we have worked for some years, we wish that all our friends in Ukraine stay safe and well.

Summary

We are absolutely delighted with the performance of our core business over the last twelve months and the cash generated from contract manufacturing has allowed us to invest in future growth opportunities - both organically, particularly in the area of enzyme production, but also through acquisition with the addition of ADL to the Group and the exciting prospects that adding a laboratory testing capacity to our overall offering opens up for us.

When I became CEO in October 2021, we had set out ambitious growth plans for EKF that would see the core business positioned to deliver substantial growth in both revenues and adjusted EBITDA. We can already see the signs of this strategy coming to fruition and I am confident that the investment put in place will see further progress in 2022 and beyond.

As a Board we remain confident in delivering on our strategy for growth into 2024 and I welcome the support from my colleagues and investors alike, as we continue to focus on execution of our plans to generate value for shareholders.

Mike Salter

Chief Executive Officer

29 March 2022

Chief Financial Officer's Review

Revenue

Revenue for 2021 was GBP81.8m (2020: GBP65.3m), an increase of 25% on the prior year. At constant 2020 exchange rates, revenue for the year excluding ADL would have been GBP85.5m, an organic growth rate of 29%.

Revenue by geographical segment based on the legal entity locations from which sales are made, is as follows:

 
                        2021           2020        +/- % 
                     GBP'000        GBP'000 
=============  =============  =============  =========== 
     Germany          34,171         20,286         +68% 
     USA              36,056         37,692         (4%) 
     UK                8,323          4,378         +90% 
     Russia            3,286          2,904         +13% 
 
     Total            81,836         65,260         +25% 
=============  =============  =============  =========== 
 
 
                     Revenue        EBITDA* 
                     GBP'000        GBP'000 
=============  =============  ============= 
     Germany          34,171         11,480 
     USA              36,056         12,735 
     UK                8,323          1,293 
     Russia            3,286            981 
 
     Total            81,836         26,489 
=============  =============  ============= 
 

* Adjusted EBITDA excludes exceptional items and share-based payments.

Germany - Significant revenue increase primarily due to sample collection tubes and kits contract manufacturing activity

USA - Contract manufacture of bulk molecular transport media and PBS for public health and private sector customers tailed off during H2

UK - Increased demand and full year effect of sample collection tubes and kits contract manufacturing activity

Russia - Increased demand in Point-of-Care portfolio. EKF's Russian entity is 60% owned by the Group but 100% of its results are consolidated, with the non-controlling interest shown separately in the income statement and statement of financial position.

As referred to in the Chief Executive Officer Review, we have taken the opportunity to recalibrate how we report revenues going forward to more closely align with our product groups and the way in which business divisions report into senior management.

Gross profit

Gross profit is GBP39.4m (2020: GBP37.4m), which represents a gross margin percentage of 48% (2020: 58%). The increased gross profit was largely due to the higher volumes. The reduction in gross margin percentage was primarily caused by changes in the mix of Contract Manufacturing related products as well as increased costs in the supply chain.

Administration costs and research and development

Administration costs have decreased to GBP17.7m (2020: GBP20.7m).

To aid understanding, administrative expenses in each period are made up as follows:

 
                                             Year ended         Year ended 
                                            31 December        31 December 
                                                   2021               2020 
                                                GBP'000            GBP'000 
     Non-exceptional administration 
      expenditure before R&D 
      capitalisation                             19,511             17,234 
     Effect of share-based 
      payments                                  (1,238)              5,292 
     Less capitalised R&D                         (659)              (586) 
     Effect of exceptional 
      items                                          95            (1,282) 
                                      -----------------  ----------------- 
     Total administrative expenses               17,709             20,658 
                                      -----------------  ----------------- 
 

The reduction is largely caused by the effect of the closure of the cash settled share-based payment schemes, which, after payments made out during the year, allowed a write-back of the remaining accrued balance of GBP1.9m.

Research and development costs included in administration expenses were GBP1.4m (2020: GBP1.4m). A further GBP0.7m (2020: GBP0.6m) was capitalised as an intangible asset, resulting from our development work to broaden and improve our product portfolio, bringing gross R&D expenditure for the year to GBP2.1m (2020: GBP2.0m). The charge for depreciation of fixed assets and amortisation of intangible assets increased to GBP5.9m (2020: GBP4.6m). The increase was mainly associated with higher amortisation of development projects, and increased depreciation on right of use assets capitalised in accordance with IFRS 16.

Operating profit and adjusted earnings before interest, tax, depreciation and amortisation

The Group generated an operating profit of GBP21.7m (2020: GBP16.9m). This was a result of the higher revenue levels seen during the year and the lower administration costs. We continue to consider that adjusted earnings before interest, tax, depreciation and amortisation, share-based payments and exceptional items (Adjusted EBITDA) is a better measure of the Group's progress as the Board believes it gives a clearer comparison of the underlying operating performance between periods. In 2021 we achieved adjusted EBITDA of GBP26.5m (2020: GBP25.5m), an increase of 4%. The calculation of this non-GAAP measure is shown on the face of the income statement. It excludes the effect of a non-cash share-based payment credit of GBP1.2m (2020: charge of GBP5.3m), and exceptional losses of GBP0.1m (2020: profit of GBP1.3m), the main elements of which are costs relating to the acquisition of ADL.

Finance costs

Net finance costs are GBP0.3m (2020: GBP1.5m). The main cost results from a decrease in the fair value of deferred consideration which is valued using the Company's share price. Although the Group holds net cash, achievable financial returns on this are very low because of low interest rates around the world.

Tax

There is an income tax charge of GBP5.3m, an increase from the prior year charge (2020: GBP4.0m), but a decrease in the tax rate to 25% from 26%. Deferred tax of GBP1.5m, calculated on the increase in the market value of listed investments over cost, has been charged direct to Other Comprehensive Income.

Dividend

A cash dividend of 1.1p per ordinary share was paid in December 2021, in respect of the final dividend for 2020. Dividends are shown in the Statement of Changes in Equity, and not in the Income Statement.

Balance sheet

Property plant and equipment and right-of-use assets

Additions to fixed assets were GBP5.7m (2020: GBP2.1m), and fixed assets rose by a further GBP0.9m recognised on the acquisition of ADL. Major programmes include the continuing work on the fit out of the new factory building in nearby South Bend and upgrading and refurbishment of the Group's manufacturing facility in Elkhart, USA and the; and the capitalisation of new and replacement leases under IFRS 16 including new properties in the UK and USA. These leases are either for three years or less, or have break clauses that limit our commitment to a maximum of three years.

Intangible assets

The carrying value of intangible assets has increased, from GBP37.1m at the end of 2020 to GBP41.9m as at 31 December 2021. This is due to the intangible assets of GBP8.0m recognised on the acquisition of ADL.

Investments

At year-end, the Company continues to hold 1.39% of the issued share capital of Renalytix plc, a developer of artificial intelligence enabled acute kidney injury products, and 1.89% of Verici Dx plc, a developer of advanced clinical diagnostics for organ transplant. The market value of these investments increased by GBP1.1m during the year. Post year end the Company invested a further GBP2.5m in Verici alongside other existing and new investors participating in a placing of new ordinary shares. Further to the investment, the Company holds 5.8% of Verici DX plc. EKF intends that its holding in Verici will be distributed to its own underlying shareholders as soon as reasonably practicable and subject to appropriate arrangements to maintain an orderly market in Verici's shares following such distribution.

Deferred consideration

The deferred consideration of GBP2.9m at the start of last year has been written back, along with its associated warranty claim debtor, following settlement of the dispute. A small payment has been made to the former owner of EKF's German operations. The new balance of GBP0.6m (2020: GBP2.9m) is for deferred and contingent consideration relating to ADL, which has been estimated at its fair value.

Cash and working capital

Net cash (which excludes marketable securities and lease creditors assessed in relation to IFRS 16 assets) has decreased to GBP19.6m from GBP21.4m. Gross cash has fallen to GBP20.3m (2020: GBP21.9m). Existing Borrowings reduced in line with repayments to GBP0.3m (2020: GBP0.5m), while borrowings overall rose as a result of borrowings held by ADL on acquisition of GBP0.4m, which have been settled post year end. Cash generated by operations is GBP14.2m (2020: GBP20.8m) mainly influenced by the effect of share-based payments.

Investment has been made in the acquisition of fixed assets (GBP4.3m excluding IFRS 16 leases). Working capital grew by GBP6.7m during the period, particularly as a result of additional inventory carried in the USA. Payments during the year under the now closed previous exit bonus scheme totalled GBP5.3m. The dividend paid in December 2021 totalled GBP5.1m.

Marc Davies

Chief Financial Officer

29 March 2022

Consolidated Income Statement

for the year ended 31 December 2021

 
 
 
 
 
                                                                    2021            2020 
                                                                 GBP'000         GBP'000 
=====================================================  =================  ============== 
     Revenue                                                      81,836          65,260 
     Cost of sales                                              (42,470)        (27,840) 
=====================================================  =================  ============== 
     Gross profit                                                 39,366          37,420 
     Administrative expenses                                    (17,709)        (20,658) 
     Other income                                                     90             133 
=====================================================  =================  ============== 
     Operating profit                                             21,747          16,895 
=====================================================  =================  ============== 
     Depreciation and amortisation                               (5,885)         (4,611) 
     Share-based payments                                          1,238         (5,292) 
     Exceptional items                                              (95)           1,282 
     EBITDA before exceptional items and share-based 
      payments                                                    26,489          25,516 
=====================================================  =================  ============== 
     Finance income                                                   45              53 
     Finance costs                                                 (357)         (1,592) 
=====================================================  =================  ============== 
     Profit before income tax                                     21,435          15,356 
     Income tax charge                                           (5,277)         (3,971) 
=====================================================  =================  ============== 
     Profit for the year                                          16,158          11,385 
=====================================================  =================  ============== 
     Profit attributable to: 
     Owners of the parent                                         15,851          11,114 
     Non-controlling interest                                        307             271 
=====================================================  =================  ============== 
                                                                  16,158          11,385 
=====================================================  =================  ============== 
 
 
                                                                   Pence           Pence 
=====================================================  =================  ============== 
     Earnings per Ordinary Share attributable to the 
      owners of the parent during the year 
     From continuing operations 
     Basic                                                          3.47            2.45 
     Diluted                                                        3.44            2.42 
=====================================================  =================  ============== 
 

Consolidated Statement of Comprehensive Income

for the year ended 31 December 2021

 
 
 
 
 
                                                               2021            2020 
                                                            GBP'000         GBP'000 
===================================================  ==============  ============== 
     Profit for the year                                     16,158          11,385 
===================================================  ==============  ============== 
     Other comprehensive (loss)/income: 
     Items that will not be reclassified to profit 
      or loss 
      Changes in fair value of equity instruments 
      at fair value through other comprehensive 
      (loss)/income (net of tax)                              (321)           3,276 
     Items that may be subsequently reclassified 
      to profit or loss 
     Currency translation differences                       (1,226)             734 
===================================================  ==============  ============== 
     Other comprehensive (loss)/income (net of 
      tax)                                                  (1,547)           4,010 
===================================================  ==============  ============== 
     Total comprehensive income for the year                 14,611          15,395 
===================================================  ==============  ============== 
     Attributable to: 
     Owners of the parent                                    14,315          15,235 
     Non-controlling interests                                  296             160 
===================================================  ==============  ============== 
     Total comprehensive income for the year                 14,611          15,395 
===================================================  ==============  ============== 
 

Consolidated Statement of Financial Position

as at 31 December 2021

 
                                               Group 2021         Group 2020 
                                                  GBP'000            GBP'000 
=====================================   =================  ================= 
     Assets 
     Non-current assets 
     Property, plant and equipment                 15,991             12,620 
     Right-of-use asset                             1,875              1,019 
     Intangible assets                             41,894             37,051 
     Investments                                    7,789              6,608 
     Deferred tax assets                               15                 14 
======================================  =================  ================= 
     Total non-current assets                      67,564             57,312 
======================================  =================  ================= 
     Current assets 
     Inventories                                   13,238              8,487 
     Trade and other receivables                   13,428             13,182 
     Current income tax receivable                    548                371 
     Cash and cash equivalents                     20,341             21,913 
======================================  =================  ================= 
     Total current assets                          47,555             43,953 
======================================  =================  ================= 
     Total assets                                 115,119            101,265 
======================================  =================  ================= 
     Equity attributable to owners 
      of the parent 
     Share capital                                  4,639              4,550 
     Share Premium                                  7,375                200 
     Other reserves                                 5,033              5,354 
     Foreign currency reserves                      2,813              4,028 
     Retained earnings                             74,264             63,516 
======================================  =================  ================= 
                                                   94,124             77,648 
     Non-controlling interest                         618                552 
======================================  =================  ================= 
     Total equity                                  94,742             78,200 
======================================  =================  ================= 
     Liabilities 
     Non-current liabilities 
     Lease liabilities                              1,095                690 
     Borrowings                                       431                323 
     Deferred consideration                           170                  - 
     Deferred tax liabilities                       5,031              2,636 
======================================  =================  ================= 
     Total non-current liabilities                  6,727              3,649 
======================================  =================  ================= 
     Current liabilities 
     Trade and other payables                       9,078             14,435 
      Lease liabilities                               838                380 
      Deferred consideration                          465              2,901 
      Current income tax liabilities                3,004              1,515 
      Borrowings                                      265                185 
======================================  =================  ================= 
      Total current liabilities                    13,650             19,416 
======================================  =================  ================= 
      Total liabilities                            20,377             23,065 
======================================  =================  ================= 
      Total equity and liabilities                115,119            101,265 
======================================  =================  ================= 
 

Consolidated Statement of Cash Flows

for the year ended 31 December 2021

 
                                                       Group           Group 
                                                        2021            2020 
                                                     GBP'000         GBP'000 
============================================   =============  ============== 
     Cash flow from operating activities 
      Cash generated by operations                    14,208          20,798 
     Interest (paid)/received                           (36)            (47) 
     Income tax paid                                 (3,934)         (6,942) 
=============================================  =============  ============== 
     Net cash generated by operating 
      activities                                      10,238          13,809 
=============================================  =============  ============== 
     Cash flow from investing activities 
      Purchase of investments                              -         (3,810) 
     Purchase of property, plant and 
      equipment (PPE)                                (4,335)         (1,631) 
     Purchase of intangibles                         (1,314)         (1,014) 
     Acquisition of subsidiaries, net                     84               - 
      of cash acquired 
     Proceeds from sale of PPE                            43              68 
     Proceeds from sale of investments                     -           7,670 
     Interest received                                    45              53 
=============================================  =============  ============== 
     Net cash (used in)/generated by 
      investing activities                           (5,477)           1,336 
=============================================  =============  ============== 
     Cash flow from financing activities 
      Share option buy back                                -             (7) 
     Proceeds from issuance of Ordinary 
      shares                                               -             209 
     Dividend                                        (5,103)         (4,550) 
     Repayments on borrowings                          (178)           (183) 
     Principal lease payments                          (643)           (469) 
     Dividend payment to non-controlling 
      interest                                         (231)           (209) 
=============================================  =============  ============== 
     Net cash used in financing activities           (6,155)         (5,209) 
=============================================  =============  ============== 
     Net(decrease)/ increase in cash 
      and cash equivalents                           (1,394)           9,936 
     Cash and cash equivalents at beginning 
      of year                                         21,913          12,074 
     Exchange losses on cash and cash 
      equivalents                                      (178)            (97) 
=============================================  =============  ============== 
     Cash and cash equivalents at end 
      of year                                         20,341          21,913 
=============================================  =============  ============== 
 

Consolidated Statement of Changes in Equity

 
                                               Share                                        Foreign 
                               Share         premium                         Other         currency         Retained                         Non-controlling            Total 
                             capital         account                      reserves          reserve         earnings           Total                interest           equity 
     Consolidated            GBP'000         GBP'000                       GBP'000          GBP'000          GBP'000         GBP'000                 GBP'000          GBP'000 
 
     At 1 January 2020         4,541               -                         6,648            3,183           56,199          70,571                     601           71,172 
----------------------  ------------  --------------  ----------------------------  ---------------  ---------------  --------------  ----------------------  --------------- 
     Comprehensive 
     income/(expense) 
     Profit for the 
      year                         -               -                             -                -           11,114          11,114                     271           11,385 
     Other 
     comprehensive 
     income/(expense) 
     Changes in fair 
      value 
      of equity 
      instruments 
      at fair value 
      through 
      other 
      comprehensive 
      income/(expense)             -               -                         4,348                -                -           4,348                       -            4,348 
     Transfer of gain 
      on disposal of 
      equity 
      investments at 
      fair 
      value through 
      other 
      comprehensive 
      income/(expense) 
      to retained 
      earnings                     -               -                       (5,642)                -            5,642               -                       -                - 
     Taxation on 
      profit 
      on disposal of 
      equity 
      instruments at 
      fair 
      value                        -               -                             -                -          (1,072)         (1,072)                       -          (1,072) 
----------------------  ------------  --------------  ----------------------------  ---------------  ---------------  --------------  ----------------------  --------------- 
     Currency 
      translation 
      differences                  -               -                             -              845                -             845                   (111)              734 
----------------------  ------------  --------------  ----------------------------  ---------------  ---------------  --------------  ----------------------  --------------- 
     Total 
      comprehensive 
      income/(expense)             -               -                       (1,294)              845           15,684          15,235                     160           15,395 
----------------------  ------------  --------------  ----------------------------  ---------------  ---------------  --------------  ----------------------  --------------- 
     Transactions with 
      owners 
     Proceeds from 
      share 
      issue                        9             200                             -                -                -             209                       -              209 
     Share option 
      cancellation                 -               -                             -                -              (7)             (7)                       -              (7) 
     Dividends to 
      non-controlling 
      interest                     -               -                             -                -                -               -                   (209)            (209) 
     Dividends to 
      owners                       -               -                             -                -          (8,360)         (8,360)                       -          (8,360) 
----------------------  ------------  --------------  ----------------------------  ---------------  ---------------  --------------  ----------------------  --------------- 
     Total 
      distributions 
      to owners                    9             200                             -                -          (8,367)         (8,158)                   (209)          (8,367) 
----------------------  ------------  --------------  ----------------------------  ---------------  ---------------  --------------  ----------------------  --------------- 
     At 31 December 
      2020 
      and 1 January 
      2021                     4,550             200                         5,354            4,028           63,516          77,648                     552           78,200 
----------------------  ------------  --------------  ----------------------------  ---------------  ---------------  --------------  ----------------------  --------------- 
 
     Comprehensive 
     income/(expense) 
     Profit for the 
      year                         -               -                             -                -           15,851          15,851                     307           16,158 
     Other 
     comprehensive 
     expense 
     Changes in fair 
      value 
      of equity 
      instruments 
      at fair value 
      through 
      other 
      comprehensive 
      expense                      -               -                         (321)                -                -           (321)                       -            (321) 
     Currency 
      translation 
      differences                  -               -                             -          (1,215)                -         (1,215)                    (11)          (1,226) 
----------------------  ------------  --------------  ----------------------------  ---------------  ---------------  --------------  ----------------------  --------------- 
     Total 
      comprehensive 
      income                       -               -                         (321)          (1,215)           15,851          14,315                     296           14,611 
----------------------  ------------  --------------  ----------------------------  ---------------  ---------------  --------------  ----------------------  --------------- 
     Transactions with 
      owners 
     Issue of ordinary 
      shares as 
      consideration 
      for a business 
      combination, 
      net of 
      transaction 
      costs                       89           7,175                             -                -                -           7,264                       -            7,264 
     Dividends to 
      non-controlling 
      interest                     -               -                             -                -                -               -                   (230)            (230) 
     Dividends to 
      owners                       -               -                             -                -          (5,103)         (5,103)                       -          (5,103) 
----------------------  ------------  --------------  ----------------------------  ---------------  ---------------  --------------  ----------------------  --------------- 
     Total 
      distributions 
      to owners                   89           7,175                             -                -          (5,103)           2,161                   (230)            1,931 
----------------------  ------------  --------------  ----------------------------  ---------------  ---------------  --------------  ----------------------  --------------- 
     At 31 December 
      2021                     4,639           7,375                         5,033            2,813           74,264          94,124                     618           94,742 
----------------------  ------------  --------------  ----------------------------  ---------------  ---------------  --------------  ----------------------  --------------- 
 

NOTES TO THE FINANCIAL STATEMENTS

for the year ended 31 December 2021

1. General information and basis of presentation

EKF Diagnostics Holdings plc is a public limited company incorporated in the United Kingdom (Registration Number 04347937), which is listed on the AIM market of the London Stock Exchange. The address of the registered office is Avon House, 19 Stanwell Road, Penarth, CF64 2EZ.

The Group's principal activity continues to be that of a business focused within the In-Vitro Diagnostics devices ("IVD") marketplace.

The financial information within this preliminary announcement is extracted from the Group's consolidated financial statements for the year ended 31 December 2021, which were approved by the Board of Directors on 29 March 2022. This financial information does not constitute statutory accounts within the meaning of sections 434(3) and 435(3) of the Companies Act 2006 or contain sufficient information to comply with the disclosure requirements of UK adopted International Accounting Standards (IFRS).

The Group's consolidated financial statements for the year ended 31 December 2021 have been prepared in accordance with UK adopted International Accounting Standards (IFRS) and with the requirements of the Companies Act 2006 as applicable to companies reporting under those standards. The Company's auditor, PricewaterhouseCoopers LLP, has given an unqualified report on the consolidated financial statements for the year ended 31 December 2021. The auditor's report did not include reference to any matters to which the auditor drew attention without qualifying its report and did not contain any statement under section 498 of the Companies Act 2006. The consolidated financial statements will be filed with the Registrar of Companies, subject to their approval by the Company's shareholders on 18 May 2022 at the Company's Annual General Meeting.

Statutory accounts for the year to 31 December 2020 have been delivered to the Registrar of Companies. The audit report for those accounts was unqualified and did not contain statements under 498 (2) or (3) of the Companies Act 2006 and did not contain any emphasis of matter.

Certain statements in this announcement constitute forward-looking statements. Any statement in this announcement that is not a statement of historical fact including, without limitation, those regarding the Company's future expectations, operations, financial performance, financial condition and business is a forward-looking statement. Such forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially. These risks and uncertainties include, amongst other factors, changing economic, financial, business or other market conditions. These and other factors could adversely affect the outcome and financial effects of the plans and events described in this announcement and the Company undertakes no obligation to update its view of such risks and uncertainties or to update the forward-looking statements contained herein. Nothing in this announcement should be construed as a profit forecast.

2. Significant accounting policies - Going concern

The Directors have considered the applicability of the going concern basis in the preparation of these financial statements. This included the review of internal budgets and financial results which show, taking into account reasonably plausible changes in financial performance, that the Group will be able to operate within the level of its current funding arrangements.

While we have continued to see some disruption to our core business as a result of the COVID-19 pandemic, we have protected our core business as far as possible and core revenue has grown by 14% this year . It is clear that healthcare activities are returning to normal and that our base case forecasts for our core business are still applicable. While the pandemic has sadly been very costly for many in lives and income, EKF has been able to learn new skills and develop a business model which offers great possibilities in the post-pandemic world. However, we are adopting a pragmatic view that there will be a significant reduction in pandemic-related contract manufacturing activity for the remainder of the year.

The Group has revenues from customers in Russia and an entity based there. As a result of the sanctions recently imposed on Russia by the EU, the USA and other countries, there are enhanced risks in respect of our Russian entity, including credit risk to cash balances, its ability to collect debtors, and our ability to import products into Russia. In preparing a downside going concern forecast we have discounted sales from this region.

While any further economic disruption stemming from the pandemic is impossible to forecast, the strength of the Group's balance sheet aligned to the continuing performance of the business gives the Directors confidence that the business can continue to meet its obligations as they fall due, even under our worst case scenarios, for at least the next 12 months. Accordingly, the directors are satisfied they can prepare the accounts on a going concern basis.

While the financial information included in this preliminary announcement has been prepared in accordance with the recognition and measurement criteria of IFRS, this announcement does not itself contain sufficient information to comply with IFRSs. The Company will publish its full financial statements for the year ended 31 December 2021 by 22 April 2022, which will be available on the Company's website at www.ekfdiagnostics.com and at the Company's registered office at Avon House, 19 Stanwell Road Penarth CF64 2EZ. The Annual General Meeting will be held on Wednesday 18 May 2022.

3. Segmental reporting

Management has determined the Group's operating segments based on the monthly management reports presented to the Chief Operating Decision Maker ('CODM'). The CODM is the Executive Directors and the monthly management reports are used by the Group to make strategic decisions and allocate resources.

The principal activity of the Group is the design, development, manufacture and sale of diagnostic instruments, reagents and certain ancillary products, as well as central laboratory reagents. This activity takes place across various countries, such as the USA, Germany, Russia, and the United Kingdom, and as such the Board considers the business primarily from a geographic perspective. Although not all the segments meet the quantitative thresholds required by IFRS 8, management has concluded that all segments should be maintained and reported.

The reportable segments derive their revenue primarily from the manufacture and sale of medical diagnostic equipment and reagents. Other services include the servicing and distribution of third-party company products under separate distribution agreements. Transactions between segments consist of the sale of products for resale. The basis of accounting for these transactions is the same as for external revenue.

Currently the key operating performance measures used by the CODM are Revenue and adjusted EBITDA.

The segment information provided to the Board for the reportable segments for the year ended 31 December 2021 is as follows:

 
                                              Germany             USA        Russia             UK           Total 
     2021                                     GBP'000         GBP'000       GBP'000        GBP'000         GBP'000 
====================================  ===============  ==============  ============  =============  ============== 
 
       Income statement 
       Revenue                                 39,665          38,974         3,286          8,514          90,439 
     Inter-segment                            (5,494)         (2,918)             -          (191)         (8,603) 
====================================  ===============  ==============  ============  =============  ============== 
     External revenue                          34,171          36,056         3,286          8,323          81,836 
====================================  ===============  ==============  ============  =============  ============== 
 
       Adjusted EBITDA*                        11,480          12,735           981          1,293          26,489 
     Exceptional items (Note 
      4)                                        (452)               -             -            357            (95) 
     Share-based payments                           -               -             -          1,238           1,238 
====================================  ===============  ==============  ============  =============  ============== 
 
       EBITDA                                  11,028          12,735           981          2,888          27,632 
     Depreciation                               (752)           (938)          (57)          (294)         (2,041) 
     Amortisation                             (1,525)         (1,383)             -          (936)         (3,844) 
====================================  ===============  ==============  ============  =============  ============== 
 
       Operating profit/(loss)                  8,751          10,414           924          1,658          21,747 
     Finance income                                 -               7            38              -              45 
     Finance cost                                (31)            (37)             -          (289)           (357) 
     Income tax                               (2,806)         (2,402)         (193)            124         (5,277) 
====================================  ===============  ==============  ============  =============  ============== 
     Profit for the year                        5,914           7,982           769          1,493          16,158 
====================================  ===============  ==============  ============  =============  ============== 
 
       Segment assets 
       Operating assets                        29,672          59,803           431         29,860         119,766 
     Inter-segment assets                     (1,441)        (16,712)             -        (6,835)        (24,988) 
====================================  ===============  ==============  ============  =============  ============== 
     External operating assets                 28,231          43,091           431         23,025          94,778 
     Cash                                       8,384           5,734         1,344          4,879          20,341 
====================================  ===============  ==============  ============  =============  ============== 
     Total assets                              36,615          48,825         1,775         27,904         115,119 
====================================  ===============  ==============  ============  =============  ============== 
 
       Segment liabilities 
       Operating liabilities                    6,387          24,796           167         13,319          44,669 
     Inter-segment liabilities                  (608)        (17,703)             -        (6,677)        (24,988) 
====================================  ===============  ==============  ============  =============  ============== 
     External operating liabilities             5,779           7,093           167          6,642          19,681 
     Borrowings                                   303             393             -              -             696 
====================================  ===============  ==============  ============  =============  ============== 
     Total liabilities                          6,082           7,486           167          6,642          20,377 
====================================  ===============  ==============  ============  =============  ============== 
 
       Other segmental information 
       Non-current assets - 
       PPE                                      5,628           8,291            80          1,992          15,991 
     Non-current assets - 
      Intangibles                              15,429          16,911            76          9,478          41,894 
     PPE - additions                              693           3,366            17          1,610           5,686 
     Intangible assets - additions                694           8,171             -            521           9,386 
====================================  ===============  ==============  ============  =============  ============== 
 

* Adjusted EBITDA excludes exceptional items and share-based payments.

The UK includes head office costs

 
 
                              Germany               USA                  Russia                UK ^               Total 
         2020                 GBP'000               GBP'000              GBP'000               GBP'000          GBP'000 
======================  =============  ====================  ===================  ====================  =============== 
 
         Income 
         statement 
         Revenue               25,637                39,459                2,904                 4,432           72,432 
       Inter-segment          (5,351)               (1,767)                    -                  (54)          (7,172) 
======================  =============  ====================  ===================  ====================  =============== 
       External 
        revenue                20,286                37,692                2,904                 4,378           65,260 
======================  =============  ====================  ===================  ====================  =============== 
 
         Adjusted 
         EBITDA*                7,343                20,094                  833               (2,754)           25,516 
       Exceptional 
        items (Note 4)            877                     -                    -                   405            1,282 
       Share-based 
        payments                    -                     -                    -               (5,292)          (5,292) 
======================  =============  ====================  ===================  ====================  =============== 
 
         EBITDA                 8,220                20,094                  833               (7,641)           21,506 
       Depreciation             (787)                 (511)                 (24)                 (522)          (1,844) 
       Amortisation           (1,646)               (1,120)                  (1)                     -          (2,767) 
======================  =============  ====================  ===================  ====================  =============== 
 
         Operating 
         profit/(loss)          5,787                18,463                  808               (8,163)           16,895 
       Finance income               2                    13                   39                   (1)               53 
       Finance cost              (26)                     -                    -               (1,566)          (1,592) 
       Income tax               (820)               (3,497)                (171)                   517          (3,971) 
======================  =============  ====================  ===================  ====================  =============== 
       Profit for the 
        year                    4,943                14,979                  676               (9,213)           11,385 
======================  =============  ====================  ===================  ====================  =============== 
 
         Segment 
         assets 
         Operating 
         assets                39,961                36,899                  355                30,529          107,744 
       Inter-segment 
        assets                  (112)              (11,427)                    -              (16,853)         (28,392) 
======================  =============  ====================  ===================  ====================  =============== 
       External 
        operating 
        assets                 39,849                25,472                  355                13,676           79,352 
       Cash                     3,130                 7,459                1,257                10,067           21,913 
======================  =============  ====================  ===================  ====================  =============== 
       Total assets            42,979                32,931                1,612                23,743          101,265 
======================  =============  ====================  ===================  ====================  =============== 
 
         Segment 
         liabilities 
         Operating 
         liabilities            7,135                17,836                  158                25,820           50,949 
       Inter-segment 
        liabilities           (1,332)              (14,915)                    -              (12,145)         (28,392) 
======================  =============  ====================  ===================  ====================  =============== 
       External 
        operating 
        liabilities             5,803                 2,921                  158                13,675           22,557 
       Borrowings                 508                     -                    -                     -              508 
======================  =============  ====================  ===================  ====================  =============== 
       Total 
        liabilities             6,311                 2,921                  158                13,675           23,065 
======================  =============  ====================  ===================  ====================  =============== 
 
         Other 
         segmental 
         information 
         Non-current 
         assets - PPE           5,912                 4,632                   93                 3,002           13,639 
       Non-current 
        assets - 
        Intangibles            24,039                10,979                   77                 1,956           37,051 
       PPE - additions            779                   575                   54                   741            2,149 
       Intangible 
        assets - 
        additions                 679                   335                    -                     -            1,014 
======================  =============  ====================  ===================  ====================  =============== 
 

* Adjusted EBITDA excludes exceptional items and share-based payments.

^ The UK segment was presented as "Other" in the 2020 financial information. There have been no changes to the numbers presented.

The UK includes head office costs

 
     Disclosure of Group revenues by geographic location 
      of customer is as follows: 
                                                                           2021                  2020 
                                                                        GBP'000               GBP'000 
=========================================================  ====================  ==================== 
     Americas 
     United States of America                                            31,522                33,474 
     Rest of Americas                                                     3,248                 2,391 
     Europe, Middle East and Africa (EMEA) 
     Germany                                                              7,942                 5,873 
     United Kingdom                                                       8,848                 4,522 
     Ireland                                                             14,292                 5,408 
     Rest of Europe                                                       4,616                 3,127 
     Russia                                                               3,286                 2,904 
     Middle East                                                          1,464                 1,261 
     Africa                                                               2,323                 2,553 
     Asia and Rest of World 
     China                                                                  985                   767 
     Rest of Asia and Oceania                                             3,310                 2,980 
     Total revenue                                                       81,836                65,260 
=========================================================  ====================  ==================== 
 

Revenues of GBP14,225,000 (17%) were derived from one external customer. Sales to this customer all relate to Europe. In 2020 revenues of GBP16,960,000 (26%) were derived from a different customer, all of whose revenues relate to the USA.

4. Exceptional items

 
                                                                             2021           2020 
                                                          Note            GBP'000        GBP'000 
=================================================  ============  ================  ============= 
     - Warranty claim                                      a                  285          1,414 
     - Settlement of warranty claim and deferred           a                (179)              - 
      consideration 
      - Business reorganisation costs                      b                 (37)           (58) 
      - Acquisition costs                                  c                (164)              - 
     - Cost of Trellus set-up                              d                    -           (74) 
     Exceptional items                                                       (95)          1,282 
===============================================================  ================  ============= 
 
 
     a.       Change in the value of an estimated warranty claim which offsets the deferred 
               consideration of GBP3.2m (2020: GBP2.9m) relating to a share-based payment to 
               the former owner of EKF-Diagnostic GmbH. The dispute has now been settled resulting 
               in a payment in cash to the former owner of GBP179,000. The remaining warranty 
               claim and deferred consideration have both been written down and there is no 
               further liability. 
     b.       Restructuring costs, mainly closure costs, associated in 2020 with the closure 
               of EKF's Polish facility and other restructuring activities, and in 2021 with 
               EKF Ireland. 
     c.       Professional fees relating to the acquisition of Advanced Diagnostic Laboratory 
               LLC 
     d.       Start-up costs in 2020 associated with the set-up of Trellus Health plc. 
 

5. Income tax charge

 
                                                                  2021           2020 
       Group                                                   GBP'000        GBP'000 
=======================================================  =============  ============= 
     Current tax: 
     Current tax on profit for the year                          5,096          3,913 
     Adjustments for prior periods                                  96             89 
=======================================================  =============  ============= 
     Total current tax                                           5,192          4,002 
 
       Deferred tax (note 29): 
     Origination and reversal of temporary differences              85           (31) 
=======================================================  =============  ============= 
     Total deferred tax                                             85           (31) 
=======================================================  =============  ============= 
     Income tax charge                                           5,277          3,971 
=======================================================  =============  ============= 
 

6. Earnings per share

(a) Basic

Basic earnings per share is calculated by dividing the profit attributable to owners of the parent by the weighted average number of Ordinary Shares in issue during the year.

 
                                                                        2021               2020 
                                                                     GBP'000            GBP'000 
=========================================================  =================  ================= 
     Profit attributable to owners of the parent                      15,851             11,114 
     Weighted average number of Ordinary Shares in issue         457,001,067        454,524,101 
=========================================================  =================  ================= 
 
       Basic profit per share                                     3.47 pence         2.45 pence 
=========================================================  =================  ================= 
 

(b) Diluted

Diluted earnings per share is calculated by adjusting the weighted average number of Ordinary Shares outstanding assuming conversion of all dilutive potential Ordinary Shares. The Company has one category of dilutive potential ordinary shares being share options.

 
                                                                       2021               2020 
                                                                    GBP'000            GBP'000 
========================================================  =================  ================= 
     Profit attributable to owners of the parent                     15,851             11,114 
     Weighted average number of Ordinary Shares 
      including potentially dilutive shares                     460,957,933        458,803,076 
========================================================  =================  ================= 
 
       Diluted profit per share                                  3.44 pence         2.42 pence 
========================================================  =================  ================= 
 
                                                                       2021               2020 
========================================================  =================  ================= 
     Weighted average number of Ordinary Shares 
      in issue 
      Adjustment for:                                           457,001,067        454,524,101 
     - Assumed conversion of share awards                            12,640            235,035 
     - Assumed payment of equity deferred consideration           3,944,226          4,043,940 
========================================================  =================  ================= 
 
     Weighted average number of Ordinary Shares 
      including potentially dilutive shares                     460,957,933        458,803,076 
========================================================  =================  ================= 
 

7. Property, Plant and equipment

 
                                            Fixtures 
                             Land and              &         Plant and            Motor        Assets under        Right-of-use 
                            buildings       fittings         machinery         vehicles        Construction               asset           Total 
     Group                    GBP'000        GBP'000           GBP'000          GBP'000             GBP'000             GBP'000         GBP'000 
===================  ================  =============  ================  ===============  ==================  ==================  ============== 
 
       Cost 
     At 1 January 
      2020                      9,760          1,552            10,275              178                 614               1,341          23,720 
     Additions                     63            122               340               54               1,052                 518           2,149 
     Exchange 
      differences                  85             26               412             (30)                  18                (14)             497 
     Transfers                    302          (285)               928                -               (945)                   -               - 
     Disposals                      -           (26)             (146)              (1)                 (4)               (245)           (422) 
===================  ================  =============  ================  ===============  ==================  ==================  ============== 
     At 31 December 
      2020                     10,210          1,389            11,809              201                 735               1,600          25,944 
===================  ================  =============  ================  ===============  ==================  ==================  ============== 
 
      Accumulated 
      depreciation 
     At 1 January 
      2020                      1,814          1,166             7,117              103                   -                 339          10,539 
     Charge for the 
      year                        302            128               902               23                   -                 489           1,844 
     Exchange 
      differences                 (4)             22               300             (18)                   -                 (2)             298 
     Transfers                    188          (188)                 -                -                   -                   -               - 
     Disposals                      -           (26)             (105)                -                   -               (245)           (376) 
===================  ================  =============  ================  ===============  ==================  ==================  ============== 
     At 31 December 
      2020                      2,300          1,102             8,214              108                   -                 581          12,305 
===================  ================  =============  ================  ===============  ==================  ==================  ============== 
     Net book value 
      at 31 
      December 2020             7,910            287             3,595               93                 735               1,019          13,639 
===================  ================  =============  ================  ===============  ==================  ==================  ============== 
 
       Cost 
     At 1 January 
      2021                     10,210          1,389            11,809              201                 735               1,600          25,944 
     Acquired with 
      subsidiary 
      (Note 20)                     4              -               818                -                   -                 111             933 
     Additions                    480            643               740               17               2,455               1,351           5,686 
     Exchange 
      differences               (195)           (48)             (271)              (2)                (19)                  12           (523) 
     Transfers                    219            130               339                -               (688)                   -               - 
     Disposals                    (7)          (102)             (247)             (56)                (13)                (64)           (489) 
-------------------  ----------------  -------------  ----------------  ---------------  ------------------  ------------------  -------------- 
     At 31 December 
      2021                     10,711          2,012            13,188              160               2,470               3,010          31,551 
-------------------  ----------------  -------------  ----------------  ---------------  ------------------  ------------------  -------------- 
 
      Accumulated 
      depreciation 
     At 1 January 
      2021                      2,300          1,102             8,214              108                   -                 581          12,305 
     Charge for the 
      year                        328            290               786               24                   -                 613           2,041 
     Exchange 
      differences                (26)           (42)             (137)              (2)                   -                   5           (202) 
     Transfers                      -              -                 -                -                   -                   -               - 
     Disposals                    (7)          (101)             (238)             (49)                   -                (64)           (459) 
     At 31 December 
      2021                      2,595          1,249             8,625               81                   -               1,135          13,685 
 
     Net book value 
      at 31 
      December 2021             8,116            763             4,563               79               2,470               1,875          17,866 
-------------------  ----------------  -------------  ----------------  ---------------  ------------------  ------------------  -------------- 
 

8. Intangible assets

 
 
                          Goodwill       Trademarks,            Customer         Trade       Development       Software         Total 
                                          trade name       relationships       secrets             costs              & 
                                                 and                                                            website 
                                            Licences 
     Group                 GBP'000           GBP'000             GBP'000       GBP'000           GBP'000        GBP'000       GBP'000 
===================  =============  ================  ==================  ============  ================  =============  ============ 
 
       Cost 
     At 1 January 
      2020                  26,371             2,799              15,580        18,436             9,060            299        72,545 
     Additions                   -               146                   -             -               586            282         1,014 
     Disposals                   -                 -                   -             -           (5,482)              -       (5,482) 
     Exchange 
      differences              632               372                (39)           620               289             12         1,886 
===================  =============  ================  ==================  ============  ================  =============  ============ 
     At 31 December 
      2020                  27,003             3,317              15,541        19,056             4,453            593        69,963 
===================  =============  ================  ==================  ============  ================  =============  ============ 
     Accumulated 
     amortisation 
     and impairment 
     At 1 January 
      2020                   2,550             2,389              10,358        13,141             6,340              -        34,778 
     Disposals                   -                 -                   -             -           (5,474)              -       (5,474) 
     Exchange 
      differences               55               201                (47)           401               231              -           841 
     Charge for the 
      year                       -               357               1,245           919               246              -         2,767 
===================  =============  ================  ==================  ============  ================  =============  ============ 
     At 31 December 
      2020                   2,605             2,947              11,556        14,461             1,343              -        32,912 
===================  =============  ================  ==================  ============  ================  =============  ============ 
 
     Net book value 
      at 31 
      December 
      2020                  24,398               370               3,985         4,595             3,110            593        37,051 
===================  =============  ================  ==================  ============  ================  =============  ============ 
     Cost 
     At 1 January 
      2021                  27,003             3,317              15,541        19,056             4,453            593        69,963 
     Acquisition of 
      subsidiary             3,755               467               1,166             -                 -          2,684         8,072 
     Additions                   -               104                   -             -             1,137             73         1,314 
     Transfer                    -               152                   -             -             (152)              -             - 
     Disposals             (1,407)              (19)               (749)       (1,073)             (288)              -       (3,536) 
     Exchange 
      differences            (793)               263               (252)         (655)             (127)             20       (1,544) 
===================  =============  ================  ==================  ============  ================  =============  ============ 
     At 31 December 
      2021                  28,558             4,284              15,706        17,328             5,023          3,370        74,269 
===================  =============  ================  ==================  ============  ================  =============  ============ 
 
      Accumulated 
      amortisation 
      and 
      impairment 
     At 1 January 
      2021                   2,605             2,947              11,556        14,461             1,343              -        32,912 
     Disposals             (1,407)              (19)               (749)       (1,073)             (288)              -       (3,536) 
     Exchange 
      differences             (21)             (144)               (203)         (454)              (24)              1         (845) 
     Charge for the 
      year                       -               237               1,221         1,730               548            108         3,844 
===================  =============  ================  ==================  ============  ================  =============  ============ 
     At 31 December 
      2021                   1,177             3,021              11,825        14,664             1,579            109        32,375 
===================  =============  ================  ==================  ============  ================  =============  ============ 
 
     Net book value 
      at 31 
      December 
      2021                  27,381             1,263               3,881         2,664             3,444          3,261        41,894 
===================  =============  ================  ==================  ============  ================  =============  ============ 
 

9. Dividends

In December 2021, the Company paid a final dividend for 2020 of 1.1p (2020: 1.0p) per ordinary share, at a total value of GBP5,103,000 (2020: GBP4,550,000). Subject to continuing strong performance and the needs of the business, the Board intends to follow a progressive dividend policy. The Directors propose, subject to approval at the Company's next Annual General Meeting, the payment of a final dividend for 2021 of 1.2p per EKF Ordinary share held on 3 November 2022. Payment will be made on 1 December 2022. The expected total value is GBP5,567,000.

10. Cash generated by operations

 
 
                                                           Group 
                                         =================================== 
                                                       2021             2020 
                                                    GBP'000          GBP'000 
=======================================  ==================  =============== 
     Profit/(loss) before tax                        21,435           15,356 
     Adjustments for: 
     - Depreciation                                   2,041            1,844 
     - Amortisation                                   3,844            2,767 
     - Warranty claim                                 (285)          (1,414) 
     - (Profit)/loss on disposal of 
      fixed assets                                     (13)             (22) 
      - Loss on disposal of intangible 
       assets                                             -                8 
     - Share-based payments                         (6,586)            4,775 
     - Dividend received                                  -             (31) 
     - Fair value adjustment                            285            1,516 
     - Foreign exchange                                  61               26 
     - Bad debt written down                             58               45 
     - Net finance cost/(income)                         26               23 
     Changes in working capital 
     - Inventories                                  (4,601)          (2,557) 
     - Trade and other receivables                  (3,274)          (3,426) 
     - Trade and other payables                       1,217            1,888 
=======================================  ==================  =============== 
     Net cash generated by operations                14,208           20,798 
=======================================  ==================  =============== 
 

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March 29, 2022 02:00 ET (06:00 GMT)

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