TIDMDEMG

RNS Number : 2302W

Deltex Medical Group PLC

22 April 2021

22 April 2021 - Deltex Medical Group plc (AIM: DEMG), the global leader in oesophageal Doppler monitoring, today announces its results for the year ended 31 December 2020.

Deltex Medical Group plc ("Deltex Medical" or the "Group")

Results for the year ended 31 December 2020

HIGHLIGHTS

COVID-19

-- COVID-19 significantly adversely affected our principal market, elective surgery, during the year...

-- ... but we decided to use the impetus from COVID-19 to bring forward a number of changes to the business, including:

Ø targeting intensive care units ("ICUs") - where the technology was originally developed;

Ø accelerating our product development programmes; and

Ø identifying further cost reductions and efficiencies

-- these COVID-19-associated changes leave the business with a substantially stronger platform from which to grow in the future once the pandemic has subsided

Financial

-- revenues: GBP2.4 million (2019: GBP4.3 million)

-- 16% reduction in overhead costs (excluding exceptionals) to GBP2.7 million (2019: GBP3.2 million)

-- adjusted EBITDA: GBP(0.2) million (2019: GBP0.4 million)

-- loss (before exceptional items) for the year: GBP(0.6) million (2019: GBP(0.1) million)

-- loss for the year: GBP(0.8) million (2019: GBP(0.2) million)

-- cash at hand (31 December, 2020): GBP0.9 million (2019: GBP0.9 million)

Business

-- significant opportunity for Deltex Medical arising from the pressure on international healthcare systems to tackle the backlog of elective surgical procedures - where TrueVue Doppler has been shown to help reduce patient length of hospital stay

-- elective surgery volumes are starting to climb in the UK and overseas

-- we have established a more significant ICU market in the UK as a result of COVID-19

-- next generation monitor to be released in Q4 2021 - with good revenue potential for new monitor sales and from the replacement of existing units

-- emerging opportunity around the use of TrueVue Doppler data to create curated data sets to improve patient care

-- positive market dynamics associated with recent consolidation in the haemodynamic monitoring sector led by major healthcare companies

-- increasingly robust regulatory environment requiring manufacturers of medical devices to submit efficacy data generated by their own products, as opposed to citing third parties' data, which enhances the value of the Group's strong proprietary evidence base

Board

-- David Moorhouse, currently Group Finance Director, has informed the Board that he wishes to retire from the Board at the AGM on 27 May 2021

-- Natalie Wettler, currently the Group Financial Controller, will, subject to standard regulatory process, be promoted to Group Finance Director from the AGM

Nigel Keen, Chairman of Deltex Medical, said:

"Like for so many businesses, COVID-19 represented a large shock with some short-term adverse consequences for the Group. However, it is clear that Deltex Medical has used the impetus of COVID-19 to make changes that leave the business significantly better positioned for the future"

"We are encouraged by the prospects that we believe will arise for Deltex Medical as a result of recent consolidation in the sector as well as the need to clear the backlog associated with elective surgery that exists around the world."

"We are also excited by the success of the new product development programmes that have been driven hard during lock down."

"We are looking forward to seeing the business starting to grow robustly once the pandemic abates."

For further information, please contact:

 
 Deltex Medical Group plc                   01243 774 837 
 Nigel Keen, Chairman                        investorinfo@Deltexmedical.com 
 Andy Mears, Chief Executive 
 David Moorhouse, Group Finance Director 
 
 Arden Partners plc                         020 7614 5900 
 Paul Shackleton                             info@arden-partners.com 
  Ben Cryer 
 
 Joint Broker 
 Turner Pope Investments (TPI) Ltd          0203 657 0050 
 Andy Thacker                                info@turnerpope.com 
  Zoe Alexander 
 

This announcement contains Inside Information as defined under the Market Abuse Regulation (EU) No. 596/2014.

Notes for Editors

Deltex Medical manufactures and markets haemodynamic monitoring technologies which are primarily used in critical care and general surgical procedures. Deltex Medical's proprietary oesophageal Doppler monitoring ("ODM") (TrueVue Doppler) measures blood flow velocity in the central circulation in real time. Minimally invasive, easy to set-up and quick to focus, the technology generates a low-frequency ultrasound signal which is highly sensitive to changes in blood flow and measures such changes in 'real time'. Deltex Medical is the only company in the enhanced haemodynamic monitoring space to have built a robust and credible evidence base demonstrating both the clinical and economic benefits of its core technology: TrueVue Doppler. This technology has been proven in a wide range of clinical trials to reduce complications suffered by patients after surgery and consequently can save hospitals money.

Deltex Medical's TrueVue System on the CardioQ-ODM+ monitor platform now provides clinicians with two further advanced haemodynamic monitoring technologies. TrueVue Impedance is an entirely non-invasive monitoring technology which transmits low magnitude, high frequency electrical signals through the thorax and measures the changes to this signal when the heart pumps blood. TrueVue PressureWave uses the peripheral blood pressure signal analysis to give doctors information on changes in the circulation and is particularly suited to monitoring lower risk or haemodynamically stable patients. The next generation TrueVue monitor is set for release in Q4 2021.

Group goal

Haemodynamic management is now becoming widely accepted as a vital part of the anaesthesia protocols for surgical patients, as well as treating ventilated intensive care patients, including ventilated COVID-19 patients. Consequently, the Group's focus is on maximising value from the opportunities associated with: the CV-19 pandemic; the elective surgery backlog; and the higher profile of haemodynamic monitoring which has arisen from the recent consolidation in the sector. The Group aims to provide clinicians with a modern, next generation, single 'haemodynamic workstation' platform which offers them a range of technologies from simple to sophisticated to be deployed according to the patient's clinical condition as well as the skill and expertise of the user. Doing this will enable the Group to partner with healthcare providers to support modern haemodynamic management across the whole hospital.

The Group is currently in the implementation phase of achieving this goal in a number of territories worldwide, operating directly in the UK and the USA, and via agreements with approximately 40 distributors overseas.

Chairman's statement

"Navigating haemodynamics - see what we see"

Introduction

The COVID-19 ("CV-19") pandemic changed the way that many companies conducted their businesses in 2020, and Deltex Medical was no exception. Our principal activity is to provide TrueVue haemodynamic monitoring to clinicians for use in elective surgery; but operating theatres were effectively closed throughout the world for most of the year which resulted in little or no use of our probes. However, our TrueVue technology was originally developed for use in UK Intensive Care Units ("ICUs") and so we were able to redirect our resources to support hospitals and doctors who switched their focus to care for severely ill CV-19 patients in ICUs.

As soon as the scale of the CV-19 challenge became clear, we looked for opportunities to minimise damage and to create benefit from the unexpected disruption to the business. We immediately focussed on supporting our ICU customers; we consolidated and improved our marketing and on-line training resources; and we drove our product development programmes, both by moving to complete our new next generation monitor platform for launch later in 2021, and also by enhancing our signal acquisition technologies to make the TrueVue technology easier to use. These enhancements will allow us to address a much wider patient population, and broader market, than before.

A major strength of the TrueVue system is its safety and reliability. This is in large part due to the attention to detail provided by our experienced and highly trained workforce. It was clear that we needed to ensure that we looked after the safety and wellbeing of our employees to allow us to continue to service all our markets throughout the world during the pandemic, albeit at substantially lower levels than before. We have done this by maximising our use of US and UK governmental salary support schemes ("Salary Support Schemes") and obtaining governmental research and development ("R&D") grants to support our employees to the extent possible. We are pleased to report that as a result of this we did not need to make any of our employees redundant during the pandemic, thereby retaining the capability to ramp up our business as our markets recover.

As we move through the second quarter of 2021, the world is a different place. The global vaccine programmes are bringing a return to a new normality in which our business should flourish as healthcare systems significantly increase capacity to treat patients who have had their scheduled surgery postponed during 2020.

Interest in our markets is strengthening, as is evidenced by the acquisition of several of our competitors by major global medical device companies. Against this backdrop our next generation monitor launch will provide the platform to support our clinical advocates in helping the healthcare systems around the world to recover and start to deal with clinical backlogs. Our new easier-to-use technologies will expand the range of patients who will benefit from the haemodynamic information delivered by the TrueVue system.

Financial results

Group revenues for the year ended 31 December, 2020 were GBP2.4 million (2019: GBP4.3 million). The 44% year-on-year reduction reflects the near-complete closure of the global elective surgery market and the running down of stock levels by our distributors.

Gross margin was also adversely affected by the reduction in manufacturing volumes, reducing to a reported 68% (2019: 77%). We believe that this decline in reported gross margin will be transient and anticipate that as unit volumes increase, then the gross margin will recover to the higher levels seen historically.

Total overheads, excluding exceptional costs, declined significantly to GBP2.7 million (2019: GBP3.2 million), representing a 16% year-on-year reduction.

In the year the total value of the Salary Support Schemes was GBP0.4 million (2019: zero).

Adjusted EBITDA for the year (comprising earnings before interest, tax, depreciation and amortisation, share-based payments, non-executive directors' fees, as well as any exceptional items) was GBP(0.2) million (2019: GBP0.4 million).

Operating loss for the year was GBP(0.6) million (2019: GBP(0.0) million).

Exceptional items of GBP0.2 million (2019: GBP0.1 million) relate to the (non-cash) write off of previously capitalised R&D programmes which the Group has decided not to take forward. Given the acceleration and expansion of the R&D work in 2020, we decided to assess the existing portfolio of the Group's capitalised development programmes in a broader sense this year, and have concluded that the adjustment reflected by the above exceptional item is appropriate.

Loss for the year was GBP(0.8) million (2019: GBP(0.2) million).

We focus carefully on the stewardship of our cash resources. Cash at hand at 31 December 2020 was GBP0.9 million (2019: GBP0.9 million).

Commercial activities

In March 2020, we were encouraged by a significant upturn in demand from UK ICUs for our TrueVue Doppler technology to treat the initial surge of CV-19 ventilated ICU patients. The TrueVue Doppler technology had originally been developed in a London ICU. It was good to see this initial increase in ICU-related demand at the beginning of the pandemic, although this increase was not large enough to counteract the effect of cessation of elective surgery globally and as the year progressed use in ICUs reduced as fewer patients were in need of ventilation.

To respond to the constraints of remote working we invested in and improved our portfolio of digital training resources. This will help to counterbalance the restrictions imposed on salespeople or technical experts entering hospitals.

The substantial challenge faced by UK hospitals in respect of reducing the backlog associated with delayed elective surgical procedures has been recognised by the Government and additional funding has been announced to help NHS hospitals work through this backlog. Given the importance of the elective surgery market to Deltex Medical's commercial activities, investment or additional resources designed to accelerate elective surgery is expected to benefit the Group.

Our TrueVue Doppler technology has been demonstrated to reduce hospital length of stay in a significant number of published randomised clinical trials. We believe that surgical departments will increasingly take into account these data as hospitals explore new ways to reduce the elective surgery backlog as quickly as possible.

We anticipate that one of the long-lasting outcomes of the CV-19 pandemic, and the potential for future variant-associated smaller outbreaks, will be a focus on investigating new ways of increasing patient throughput as well as reducing risk in a hospital setting. The TrueVue system is well positioned to help hospitals meet these requirements.

Notwithstanding the pandemic, we continued to drive forward a number of development programmes during the year. On the back of ongoing R&D programmes, some of which were supported by competitively-awarded UK Government-funded research grants, we have made good progress on broadening the applicability of our technology in the healthcare setting. As part of this work, we now plan to launch our new next generation monitor in the second half of this year.

The greater focus on the haemodynamic condition of patients undergoing surgery and in ICUs presents new opportunities for the TrueVue technology. The very precise real-time haemodynamic beat-to-beat data generated by the TrueVue system can be used to design patient-specific algorithms which will allow clinicians to be able to predict earlier patient outcomes, thereby optimising patient care.

Employees

I would like, on behalf of the Board, to thank our highly trained and dedicated workforce who are based in the UK, Spain and the USA, and who have been extremely flexible and responsive to customers' needs during the worst months of the pandemic. Our employees always worked hard to satisfy demand for our products from hospitals which were treating high volumes of CV-19 patients.

Board changes

There have recently been a number of changes to the Board.

David Moorhouse rejoined Deltex Medical in October 2019, having previously been Group Finance Director from 1996 to 2001. David has recently informed us that he wishes to retire at the forthcoming AGM.

We are pleased to be announcing today, subject to routine regulatory process, the promotion of Natalie Wettler to the role of Group Finance Director with effect from the AGM. Natalie held a number of senior roles in the Group's finance department between 2011 and 2016. We were delighted when she agreed to rejoin the Group in January 2020 as the Group Financial Controller.

Sir Duncan Nichol retired from the Board at the end of 2020. Sir Duncan had previously been Chief Executive of the NHS from 1989 to 1994. The Group benefited from his immense experience, wisdom and extensive network of healthcare-related contacts. I would like to thank him for his contributions over the years and we wish him well for his retirement.

Tim Irish joined the Board on 20 January 2021. Tim had previously been on the Board of Deltex Medical between May 2014 and March 2015. He resigned as a Director on 31 March 2015 when he was appointed to the Board of NICE, the National Institute for Health and Care Excellence. We are delighted that he has rejoined the Board and we look forward to working with him. Tim has some 35 years of experience working in the life sciences and healthcare sectors.

Current trading and prospects

We have seen recent consolidation in our markets with several of our competitors having been acquired by larger global medical device companies. We believe this shows that the market for haemodynamic monitoring is evolving rapidly.

Currently, our sales activity levels remain comparatively subdued, as CV-19 continues to affect adversely the number of elective surgical procedures being undertaken. Moreover, many of our international distributors are reporting that their core customers are experiencing a 'third wave', and that consequently there are very low levels of elective surgery taking place. We anticipate that sales in the first half of 2021 will reflect the continuing CV-19 prevalence in many of our key markets.

In the second half of the year, based on discussions with our customers and distributors, we anticipate that there will be a significant increase in the Group's activity levels, particularly in NHS and US hospitals, as there are a number of initiatives being put in place to increase the volume of elective procedures undertaken whilst at the same time minimising in-patient stay. The lower costs, shorter length-of-stay and improved outcomes that have been demonstrated by our TrueVue Doppler technology will significantly help hospitals achieve greater surgical in-patient throughput.

This increased level of activity provides a strong backdrop for the launch of our new next generation monitor in the second half of 2021. The new monitor will also incorporate new technological developments which have been completed during lock-down which enhance the ease of use of the TrueVue system and expand the range of patients who can benefit from the use of the system.

As a result of these positive factors, the Board believes that the Group is well positioned for growth as the year progresses.

Nigel Keen

Chairman

BUSINESS REVIEW

COVID-19 - how the Group reacted to the unexpected disruption

As highlighted in the Chairman's Statement, the CV-19 pandemic caused our principal market, elective surgery, to effectively close around the globe for much of 2020. The effective cessation in elective surgical procedures forced us to review rapidly how best to react and drive the business forward, given such a challenging commercial environment. Set out below is a summary of the key actions we implemented, which included:

-- driving, as much as possible, our technology into the key ICU markets at the beginning of the pandemic as: (i) clinicians were still working out the optimal treatment regime for CV-19 patients and we were convinced that TrueVue Doppler-derived data would be helpful to establish optimised treatment protocols; (ii) before the ICUs became completely full we believed that there would be a window of opportunity to engage with intensivists; and (iii) we anticipated that once the pandemic took hold then intensivists would no longer have the time or "bandwidth" to discuss with our clinical educators how best to use the TrueVue Doppler to assist in the treatment of CV-19 patients;

-- making sure that we were able to support our customers, both face-to face and virtually, who continued to use the Group's technology during the pandemic in both the ICU and operating room;

-- evaluating how best to cope with the new challenge associated with hospitals effectively closing their doors to salespeople, which we anticipate may well carry on for some time. As part of our response to this challenge, we have significantly increased our investment in digital training and marketing resources;

-- accelerating and expanding our product development programmes. As part of our strategic decision to accelerate a number of product development initiatives, we applied for, and were awarded, an additional Innovation Continuity Grant by Innovate UK worth approximately GBP0.2 million;

-- making the strategic decision early-on that we would not make any redundancies across the company to ensure that we retained our highly trained and flexible teams for when elective surgery resumes; and

-- maximising the contribution from Salary Support Schemes which collectively amounted to GBP352,000 in the year.

We were able to implement these steps whilst still retaining a substantial level of cash at hand on the balance sheet (GBP0.9 million at 31 December 2020).

Next generation product development - good progress and expansion of applicability

We have made good progress on the development of the next generation monitor, the TrueVue System, which we plan to launch towards the end of the second half of 2021. This next generation monitoring platform will provide users with more detailed and precise information about the key characteristics of a patient's haemodynamics (blood flow and blood pressure) as well as enabling such data to be readily downloaded for further analysis. In addition, the TrueVue System will incorporate battery power, making it much more mobile and hence a clinically more useful device with broader applications.

Last year we were awarded a series of R&D grants. One of these enabled us to commission some collaborative research work with the UK's National Physics Laboratory ("NPL"). Although we have our own in-house experts, we believed that our core ultrasound technology would benefit from an independent review by world-class physicists. The feedback that we received from NPL has been extremely constructive in terms of improving our existing device; but also in the development of a new non-invasive Doppler device we are planning to release on the next generation monitoring platform. This new ultrasound device has broader utility and can be used in a number of different clinical areas that we currently do not service. These include Accident & Emergency departments, where we anticipate it acting as a sophisticated triage tool, through to looking at the haemodynamic status of conscious, un-sedated patients in a general ward setting or in the ICU.

We are expanding the specification for our next generation monitor to include this new non-invasive Doppler-based device. We are also in the process of determining, in parallel with finalising the design for the new monitor, the optimal specification for this non-invasive technology as well as establishing how it could best be used by clinicians to optimise the patient pathway in the wider hospital setting.

One challenge we face at the moment with the development of this technology is that most UK clinicians have been focussed on treating CV-19 patients, and it has been practically very difficult to carry out the clinical evaluations and receive user feedback which form an important part of our product development process.

Curated data sets - new trend seen among large MedTech groups

We are seeing a new trend, which is being led by some of the large MedTech groups, which relates to capturing raw haemodynamic data with a view to using such data to create and guide patient treatment protocols. Such 'curated data sets' comprise data linked to the patient's haemodynamic status which can subsequently be used as a reference for constructing predictive models of future clinical events. Using artificial intelligence, these curated data sets can be used to create cloud-based haemodynamic algorithms which would further improve the quality of patient care. The TrueVue System is the only haemodynamic monitoring device able to generate haemodynamic data with the requisite precision to allow such protocols to be created.

Increasing value associated with Deltex Medical's unique evidence base

Deltex Medical has invested considerable resources in compiling an unrivalled evidence base comprising 24 Randomised Clinical Trials (RCTs). The 24(th) RCT has just been published [1] . Collectively these RCTs demonstrate that, among other things, the use of Deltex Medical's TrueVue Doppler results in significantly:

-- better outcomes for patients;

-- reduced patient hospital length-of-stay; and

-- lower costs for healthcare providers.

As healthcare systems together with governmental and private (e.g. insurers) payers focus on evidence-based interventions, then the value of Deltex Medical's evidence base will become increasingly apparent.

Regulatory

There is a general trend towards more onerous regulatory requirements associated with medical devices in healthcare markets around the world, including the transition from the Medical Device Directive (MDD) to the Medical Device Regulation (MDR).

These changes mean that there is an increasing need for manufacturers of medical devices to cite efficacy data generated by their own products in regulatory submissions, as opposed to using third party data collected from other sources. As a result, we believe that the inherent value associated with the Group's evidence base will continue to climb.

There is still uncertainty from a regulatory perspective about the consequences for our business following the UK leaving the EU. Some parts of the new regulatory regime in the UK are already clear with, for example, the establishment of the new UK Conformity Assessed (UKCA) mark which has been established to replace the CE mark here in the UK. (The CE mark will still be required on Deltex Medical equipment sold into the EU.) Deltex Medical's Regulatory Affairs group is used to servicing the needs of a wide range of different national and international regulatory environments and so is well set up to handle any changes required. For example, in 2019 we moved our Notified Body which regulates our application of CE marks to Deltex Medical products from the UK to the Netherlands, in order to be ready for the regulatory changes which inevitably would arise following the United Kingdom's exit from the EU.

Three principal divisions: UK, USA and International

The commercial activities of the Group are managed in three divisions: UK, USA and International. These three divisions were all significantly held-back by the CV-19 pandemic during 2020.

We sell directly into the UK and the USA via a team of sales people and clinical educators. In the short term both of these teams face customer access challenges as hospitals have sought to exclude, or at the very least severely restrict, access to non-hospital personnel to hospitals. To counteract this, we have improved the breadth and scope of our on-line, digital training materials for clinicians, as well as appropriate supporting materials for a hospital's finance teams and purchasing departments.

We principally sell into overseas territories, other than the USA, by a network of some 40 distributors which typically sell a complementary bundle of MedTech equipment and consumables into the healthcare market in each of their territories. These distributors are able to give us real-time feedback on the status of, or developments within, each of their markets. All of them have reported a cessation of elective surgery as well as the announcement of various initiatives designed to enable a rapid catch-up of elective surgical procedures once the pandemic has abated.

Whilst the distributor network we have in place currently works effectively, we may need to expand our international footprint as our next generation products come on stream, particularly as we anticipate a broader utility and applicability for these products.

Increasing consolidation in the haemodynamic sector

The recent acquisition of several of the Group's competitors by major healthcare groups is likely to result in increased investment in the haemodynamic market which, in turn, should result in this market segment becoming larger. Historically the majority of the Group's competitors were small to medium-sized companies; however, most of these companies have now been acquired by larger, global medical device organisations. The resulting anticipated greater investment in marketing and clinical education is likely to drive broader adoption of haemodynamic monitoring across the international healthcare markets.

Conclusion

Irrespective of how quickly global vaccination programmes bring CV-19 under control, it is clear that there is a substantial backlog of elective surgery which needs to be addressed across the world. It is also clear that there is substantial pressure, from a number of sources including political, clinician-led and patient-safety advocacy groups, to reduce this backlog rapidly. This broad-based pressure to reduce the elective surgery backlog will be a key positive driver for our business.

The product development work that we accelerated during the last year resulting in the near completion of our new next generation TrueVue System will be transformative for the Group as it provides the products we can use to take advantage of the increasing addressable market for haemodynamic monitoring stimulated by the recent consolidation in the sector.

We are looking forward to the second half of this year when we expect our principal markets to reopen. We will then be able to re-assemble our team of highly trained employees at our headquarters in the UK and together drive back up Group revenues and increased cash generation.

"Navigating haemodynamics - see what we see"

Andy Mears

Chief Executive

Consolidated statement of comprehensive income

For the year ended 31 December 2020

 
                                                    2020       2019 
                                                 GBP'000    GBP'000 
--------------------------------------------   ---------  --------- 
 Revenue                                           2,398      4,256 
 Cost of sales                                     (757)      (974) 
---------------------------------------------  ---------  --------- 
 Gross profit                                      1,641      3,282 
 Administrative expenses                         (1,472)    (1,515) 
 Sales and distribution expenses                   (964)    (1,220) 
 Research and Development, Quality 
  and Regulatory                                   (246)      (446) 
 Impairment reversal/(loss) on trade 
  receivables                                         11       (11) 
 Exceptional costs                                 (232)      (137) 
 Total costs                                     (2,903)    (3,329) 
---------------------------------------------  ---------  --------- 
 Other operating income                              469          - 
--------------------------------------------   ---------  --------- 
 Other gain                                          171         13 
 Operating loss                                    (622)       (34) 
 Operating (loss)/profit before exceptional 
  costs and other gain                             (561)         90 
 
 Finance costs                                     (172)      (176) 
---------------------------------------------  ---------  --------- 
 Loss before taxation                              (794)      (210) 
 Tax credit on loss                                    9         51 
---------------------------------------------  ---------  --------- 
 Loss for the year                                 (785)      (159) 
---------------------------------------------  ---------  --------- 
 Other comprehensive expense 
 Items that may be reclassified to 
  profit or loss: 
 Net translation differences on overseas 
  subsidiaries                                       (6)        (8) 
---------------------------------------------  ---------  --------- 
 Other comprehensive expense for the 
  year, net of tax                                   (6)        (8) 
---------------------------------------------  ---------  --------- 
 Total comprehensive loss for the 
  year                                             (791)      (167) 
---------------------------------------------  ---------  --------- 
 
 Total comprehensive loss for the 
  year attributable to: 
 Owners of the Parent                              (804)      (169) 
 Non-controlling interests                            13          2 
---------------------------------------------  ---------  --------- 
                                                   (791)      (167) 
 --------------------------------------------  ---------  --------- 
 
 Loss per share - basic and diluted              (0.15p)    (0.03p) 
---------------------------------------------  ---------  --------- 
 

Consolidated balance sheet

As at 31 December 2020

 
 
                                             2020       2019 
 
                                          GBP'000    GBP'000 
------------------------------------   ----------  --------- 
 Assets 
 Non-current assets 
 Property, plant and equipment                305        395 
 Intangible assets                          2,554      2,651 
 Financial assets at amortised cost           153        157 
 Total non-current assets                   3,012      3,203 
 Current assets 
 Inventories                                  895        915 
 Trade receivables                            576      1,062 
 Financial assets at amortised cost            15        214 
 Other current assets                         122        113 
 Current income tax recoverable                61         80 
 Cash and cash equivalents                    853        908 
-------------------------------------  ----------  --------- 
 Total current assets                       2,522      3,292 
-------------------------------------  ----------  --------- 
 Total assets                               5,534      6,495 
 Liabilities 
 Current liabilities 
 Borrowings                                 (159)      (188) 
 Trade and other payables                 (1,416)    (2,198) 
 Total current liabilities                (1,575)    (2,386) 
-------------------------------------  ----------  --------- 
 Non-current liabilities 
 Borrowings                                 (993)    (1,072) 
 Trade and other payables                   (274)      (320) 
 Provisions                                  (51)       (62) 
-------------------------------------  ----------  --------- 
 Total non-current liabilities            (1,318)    (1,454) 
-------------------------------------  ----------  --------- 
 Total liabilities                        (2,893)    (3,840) 
-------------------------------------  ----------  --------- 
 Net assets                                 2,641      2,655 
-------------------------------------  ----------  --------- 
 
 Equity 
 Share capital                              5,773      5,249 
 Share premium                             33,444     33,230 
 Capital redemption reserve                17,476     17,476 
 Other reserve                                505        439 
 Translation reserve                          135        141 
 Convertible loan note reserve                 82         82 
 Accumulated losses                      (54,648)   (53,823) 
-------------------------------------  ----------  --------- 
 Equity attributable to owners of 
  the Parent                                2,767      2,794 
 Non-controlling interests                  (126)      (139) 
-------------------------------------  ----------  --------- 
 Total equity                               2,641      2,655 
-------------------------------------  ----------  --------- 
 

Consolidated statement of changes in equity for the year ended 31 December 2020

 
                                          Capital             Convertible                                         Non-controlling 
                     Share     Share   redemption     Other     loan note   Translation   Accumulated                    interest 
                   capital   premium      reserve   reserve       reserve       reserve        losses     Total                       Total 
                                                                                                                                     equity 
                   GBP'000   GBP'000      GBP'000   GBP'000       GBP'000       GBP'000       GBP'000   GBP'000           GBP'000   GBP'000 
----------------  --------  --------  -----------  --------  ------------  ------------  ------------  --------  ----------------  -------- 
 Balance at 1 
  January 2020       5,249    33,230       17,476       439            82           141      (53,823)     2,794             (139)     2,655 
 Comprehensive 
  income 
 Loss for the 
  period                 -         -            -         -             -             -         (798)     (798)                13     (785) 
 Other 
  comprehensive 
  income for the 
  period                 -         -            -         -             -           (6)             -       (6)                 -       (6) 
----------------  --------  --------  -----------  --------  ------------  ------------  ------------  --------  ----------------  -------- 
 Total 
  comprehensive 
  income for 
  year                   -         -            -         -             -           (6)         (798)     (804)                13     (791) 
 Transactions 
  with owners 
  of the Group 
 Shares issued 
  during the 
  year                 524       217            -         -             -             -             -       741                 -       741 
 Issue expenses          -       (3)            -         -             -             -             -       (3)                 -       (3) 
 Equity-settled 
  share-based 
  payment                -         -            -        39             -             -             -        39                 -        39 
 Transfers               -         -            -        27             -             -          (27)         -                 -         - 
 Balance at 
  31 December 
  2020               5,773    33,444       17,476       505            82           135      (54,648)     2,767             (126)     2,641 
----------------  --------  --------  -----------  --------  ------------  ------------  ------------  --------  ----------------  -------- 
 

Consolidated statement of changes in equity for the year ended 31 December 2019

 
                                          Capital             Convertible                                         Non-controlling 
                     Share     Share   redemption     Other     loan note   Translation   Accumulated                    interest 
                   capital   premium      reserve   reserve       reserve       reserve        losses     Total                       Total 
                                                                                                                                     equity 
                   GBP'000   GBP'000      GBP'000   GBP'000       GBP'000       GBP'000       GBP'000   GBP'000           GBP'000   GBP'000 
----------------  --------  --------  -----------  --------  ------------  ------------  ------------  --------  ----------------  -------- 
 Balance at 1 
  January 2019, 
  as restated        4,927    33,230       17,476       953            82           149      (54,293)     2,524             (141)     2,383 
 Comprehensive 
  income 
 Loss for the 
  period                 -         -            -         -             -             -         (161)     (161)                 2     (159) 
 Other 
  comprehensive 
  income for the 
  period                 -         -            -         -             -           (8)             -       (8)                 -       (8) 
----------------  --------  --------  -----------  --------  ------------  ------------  ------------  --------  ----------------  -------- 
 Total 
  comprehensive 
  income for 
  year                   -         -            -         -             -           (8)         (161)     (169)                 2     (167) 
 Transactions 
  with owners 
  of the Group 
 Equity-settled 
  share-based 
  payment                -         -            -       117             -             -             -       117                         117 
 Transfers               -         -            -     (631)             -             -           631         -                 -         - 
 Share options 
  exercised            322         -            -         -             -             -             -       322                 -       322 
----------------  --------  --------  -----------  --------  ------------  ------------  ------------  --------  ----------------  -------- 
 Balance at 31 
  December 2019      5,249    33,230       17,476       439            82           141      (53,823)     2,794             (139)     2,655 
----------------  --------  --------  -----------  --------  ------------  ------------  ------------  --------  ----------------  -------- 
 

.

Consolidated statement of cash flows

for the year ended 31 December 2020

 
                                                    2020       2019 
                                                 GBP'000    GBP'000 
--------------------------------------------   ---------  --------- 
 Cash flows from operating activities 
 Loss before taxation                              (794)      (210) 
 Adjustments for: 
 Net finance costs                                   172        176 
 Depreciation of property, plant and 
  equipment                                          103        149 
 Profit on disposal of loan monitors                   -       (36) 
 Amortisation of intangible assets                    40         84 
 Write off of research and development               222          - 
  projects not taken forward 
 Modification gain on convertible loan             (119)          - 
  note 
 Share-based payment expense                          39        117 
 Other tax income                                   (52)          - 
 Effect of exchange rate fluctuations                (6)        (2) 
                                                   (395)      (278) 
 Decrease/(increase) in inventories                   13      (235) 
 Decrease in trade and other receivables             680        427 
 (Decrease)/increase in trade and other 
  payables                                         (303)        212 
 (Decrease)/increase in provisions                  (11)          6 
---------------------------------------------  ---------  --------- 
 Net cash generated (used in) / from 
  operations                                        (16)        688 
 Interest paid                                     (132)      (139) 
 Income taxes received                                80         60 
---------------------------------------------  ---------  --------- 
 Net cash generated (used in) / from 
  operating activities                              (68)        609 
 Cash flows from investing activities 
 Purchase of property, plant and equipment           (6)       (10) 
 Proceeds from the sale of loan monitors               -         59 
 Capitalised development expenditure 
  (net of grants)                                  (165)      (250) 
 Net cash used in investing activities             (171)      (201) 
 Cash flows from / (used in) financing 
  activities 
 Issue of ordinary share capital                     253        322 
 Expenses in connection with share issue             (3)          - 
 Net movement in invoice discount facility          (23)      (356) 
 Principal lease payments                           (37)       (33) 
---------------------------------------------  ---------  --------- 
 Net cash generated from / (used in) 
  financing activities                               190       (67) 
---------------------------------------------  ---------  --------- 
 Net (decrease)/increase in cash and 
  cash equivalents                                  (49)        341 
 Cash and cash equivalents at beginning 
  of the period                                      908        580 
 Exchange loss on cash and cash equivalents          (6)       (13) 
---------------------------------------------  ---------  --------- 
 Cash and cash equivalents at end of 
  the period                                         853        908 
---------------------------------------------  ---------  --------- 
 

1. Nature of the financial information

This Results Summary containing condensed financial information for the year ended 31 December 2020 should be read in conjunction with the Deltex Medical Group Plc's Annual Report & Accounts 2020 which were in accordance with International Accounting Standards in conformity with the requirements of the Companies Act 2006. The consolidated financial statements have been prepared under the historical cost convention and on a going concern basis.

Financial information contained in this document does not constitute statutory accounts within the meaning of section 434 of the Companies Act 2006 ('the Act'). The statutory accounts for the year ended 31 December 2019 have been filed with the Registrar of Companies and those for the year ended 31 December 2020 will be filed with the Registrar of Companies following the Annual General Meeting. The report of the independent auditor on those statutory accounts was unqualified and did not contain a statement under section 498(2) or (3) of the Act. The report drew attention by way of emphasis to the matters set out below in note 2 (Accounting policies - going concern). The auditor's opinion was not modified in respect of these matters.

2. Accounting policies

The Group's principal accounting policies can be found on pages 43 to 45 of the Group's Annual Report & Accounts 2020.

Going concern

The directors have reviewed detailed budgets and cash flow forecasts until 30 June 2022. This review indicates that the Group is expected to continue trading as a going concern based on projected net cash flows derived from sales of the Group. The directors recognise that COVID-19 continues to have an impact on the demand for its products and the continued impact of COVID-19 is by its nature uncertain.

Notwithstanding the uncertainties over the impact for the Group that COVID-19 causes, the directors consider that they have reasonable grounds to believe that the Group will have adequate resources to continue in operational existence for the foreseeable future and it is therefore appropriate to prepare the financial statements on the going concern basis.

3. Revenue

 
                                For the year ended 31 December 2020 
                                Direct markets                     Indirect markets 
                     Probes   Monitors     Third     Other    Probes   Monitors     Other     Total 
                                           Party 
                    GBP'000    GBP'000   GBP'000   GBP'000   GBP'000    GBP'000   GBP'000   GBP'000 
-----------------  --------  ---------  --------  --------  --------  ---------  --------  -------- 
 UK                     652        102         -        83         -          -         -       837 
 USA                    858         16         -        26         -          -         -       900 
 France                   -          -         -         -       170          -        10       180 
 Scandinavia              -          -         -         -        95          -         2        97 
 South Korea              -          -         -         -       159          -         1       160 
 Portugal                 -          -         -         -        86          -         -        86 
 Other countries         15         32         -         -        78         11         2       138 
-----------------  --------  ---------  --------  --------  --------  ---------  --------  -------- 
                      1,525        150         -       109       588         11        15     2,398 
-----------------  --------  ---------  --------  --------  --------  ---------  --------  -------- 
 
 
                              For the year ended 31 December 2019 
                            Direct markets                     Indirect markets 
                 Probes   Monitors     Third     Other    Probes   Monitors     Other     Total 
                                       Party 
                GBP'000    GBP'000   GBP'000   GBP'000   GBP'000    GBP'000   GBP'000   GBP'000 
-------------  --------  ---------  --------  --------  --------  ---------  --------  -------- 
 UK                 902         49       293       107         -          -         -     1,351 
 USA              1,443         45         -        42         -          -         -     1,530 
 France               -          -         -         -       289          9         6       304 
 Scandinavia          -          -         -         -        83          -         1        84 
 South Korea          -          -         -         -       277         10         3       290 
 Peru                 -          -         -         -       258          -         3       261 
 Other 
  countries          29          -         -         -       251        148         8       436 
-------------  --------  ---------  --------  --------  --------  ---------  --------  -------- 
                  2,374         94       293       149     1,158        167        21     4,256 
-------------  --------  ---------  --------  --------  --------  ---------  --------  -------- 
 

The Group's revenue disaggregated between the sale of goods and the provision of services is set out below. All revenues from the sale of goods are recognised at a point in time; maintenance income is recognised over time.

 
                          2020      2019 
                       GBP'000   GBP'000 
--------------------  --------  -------- 
 Sale of goods           2,338     4,176 
 Maintenance income         60        80 
                         2,398     4,256 
--------------------  --------  -------- 
 

The following table provides information about trade receivables and contract liabilities from contracts with customers. There were no contract assets at either 31 December 2020 or 31 December 2019.

 
                                              31 December   31 December 
                                                     2020          2019 
                                                  GBP'000       GBP'000 
-------------------------------------------  ------------  ------------ 
 Trade receivables which are in 'Trade and 
  other receivables'                                  576         1,062 
 Contract liabilities                                (58)          (53) 
-------------------------------------------  ------------  ------------ 
 

The following aggregated amounts of transaction prices relate to the performance obligations from existing contracts that are unsatisfied or partially unsatisfied as at 31 December 2020:

 
                                               2021          2022          2023     Total 
                                            GBP'000       GBP'000       GBP'000   GBP'000 
-------------------------------------  ------------  ------------  ------------  -------- 
 Revenue expected to be 
  recognised                                     54             1             3        58 
-------------------------------------  ------------  ------------  ------------  -------- 
  Revenue recognised in 2020 which was included in contract liabilities 
   at 31 December 2019 amounted to GBP46,000. Revenue recognised 
   in 2019 included in contract liabilities at 31 December 2018 amounted 
   to GBP131,000. 
 
 

4. Dividends

The directors cannot recommend payment of a dividend (2019:nil).

5. Basic and diluted loss per share

The loss per share calculation is based on the loss of GBP798,000 and the weighted average number of shares in issue of 526,448,659. For 2019, the loss per share calculation is based on the loss of GBP161,000 and the weighted average number of shares in issue of 509,679,881. While the Group is loss-making, the diluted loss per share and the loss per share are the same.

[1] Halawa N et al., Respiratory and Hemodynamic effects of prophylactic alveolar recruitment during liver transplant: a RCT, Journal of Experimental and Clinical Transplantation, March 2021

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April 22, 2021 02:00 ET (06:00 GMT)