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RNS Number : 1024T  Ergomed plc  23 March 2021

PRESS RELEASE

 

Audited Full Year Results for the year ended 31 December 2020

 

·    Adjusted EBITDA £19.4 million (up 55.2%)

·    Revenue £86.4 million (up 26.5%)

·    Strategic acquisitions in CRO and pharmacovigilance in the US
strengthen global specialist leadership

·    Forward visibility underpinned by strong order book of £193 million
(up 55.5%)

·    Year-end net cash balance of £19.0 million with unutilised credit
facilities of £30 million

 

Guildford, UK - 23 March 2021: Ergomed plc (LSE: ERGO) ('Ergomed' or the
'Company' or the 'Group'), a company focused on providing specialised services
to the pharmaceutical industry, today announces its audited Full Year Results
for the year ended 31 December 2020.

 

Selected Financial Highlights

 

                                                     Full          Full     % change

                                                     Year 2020     Year

                                                                   2019
 Figures in £ millions, unless otherwise stated
 Total Revenue                                       86.4          68.3     26.5
 Service Fee Revenue                                 78.4          59.2     32.4
 Like-for-like Service Fee Revenue (Note 1)          68.6          57.6     19.1
 Gross Profit                                        39.7          29.5     34.6
 Gross Margin (%)                                    45.9%         43.3%    +2.6ppts
 Adjusted EBITDA (Note 2)                            19.4          12.5     55.2
 Net cash at 31 December                             19.0          14.3     32.9
 Order book at 31 December                           193.0         124.1    55.5
 Basic adjusted earnings per share (pence) (Note 3)  25.8p         19.9p    29.6

 

 

 

 

 

 

 

 

 

Notes:

(1) Like-for-like Service Fee revenue excludes 2020 revenues of £9.2 million
in PrimeVigilance USA Inc acquired on 10 January 2020 and £0.6 million in MS
Clinical Services, LLC. and its subsidiaries ('MedSource') acquired on 11
December 2020, as well as exceptional 2019 revenues of £1.6 million.

(2) Adjusted EBITDA is defined as operating profit for the period plus
depreciation and amortisation, share-based payment charge, acquisition related
consideration and costs and exceptional items, less one-off receipts in the
period comprising a prior year R&D tax credit and Serbian employment
growth grants (Note 9 to the financial statements).

(3) Basic adjusted earnings per share is defined as earnings per share after
adjustment for items referred to in Note 8 to the financial statements.

 

Dr Miroslav Reljanović, Executive Chairman of Ergomed, said: "Ergomed made
exceptional progress in delivering its strategy in 2020, despite the
challenges of the COVID-19 pandemic. The resilience and robustness of our
global services business was demonstrated by our continued strong organic
growth whilst completing key strategic acquisitions in the US in both our
pharmacovigilance and CRO businesses. We have started 2021 in a strong
position, focused on our vision to achieve global leadership in specialised
pharmaceutical services addressing unmet medical needs and patient safety."

 

Key Financial Highlights

 

·      Revenue of £86.4 million increased by 26.5% (2019: £68.3
million)

‒      Revenue growth in pharmacovigilance (PV) up 55.6% to £55.1
million (2019: £35.4 million) and up 30.0% to £46.0 million on a
like-for-like basis excluding the acquisition of Ashfield Pharmacovigilance

‒      Revenue in Clinical Research Services (CRO) flat at £31.3
million (2019: £31.2 million excluding exceptional revenue) despite COVID-19,
with service fee revenue returning to growth in H2 up 13.5% over H1

·      Gross profit up 34.6% to £39.7 million (2019: £29.5 million)

·      Adjusted EBITDA(2) up 55.2% to £19.4 million (2019: £12.5
million)

·      Basic adjusted EPS up 29.6% to 25.8p (2019: 19.9p)

·      Cash and cash equivalents up 32.9% to £19.0 million at 31
December 2020 (31 December 2019: £14.3 million) with operating cash flow of
£19.0m

·      Order book of £193.0 million future contracted revenue up 55.5%
at 31 December 2020 (31 December 2019: £124.1 million)

 

Key Operational Highlights

 

·      Continued strong growth trend in challenging markets

·      Demonstrated resilience and ability to contribute in COVID-19
crisis

·      Completed two strategic acquisitions in USA to significantly
expand our presence in both pharmacovigilance and CRO

-       Ashfield Pharmacovigilance (now PrimeVigilance USA), acquired in
January 2020, rapidly and successfully integrated

-       MS Clinical Services, LLC. and its subsidiaries ('MedSource'),
acquired December 2020, in process of integration

·      US revenue growth 82.4% over prior year

·      Successful focus on business development and cross-selling
opportunities

 

 

COVID-19 Update

 

The Group continues to monitor closely developments relating to the
unprecedented global healthcare challenge of the COVID-19 pandemic. We have
been able to adapt our business model to the challenge and are proud to play a
role in helping to combat the disease. We are confident that we will continue
to be able to bring our expertise and proven capabilities to bear in advancing
drug development in the field and improving outcomes for patients.

 

 

Conference call for analysts:

A conference call for analysts will be held at 9.00am GMT on 23 March 2021.

 

Conference call details:

 

Participant dial-in: 080 0279 6619

International dial-in: +44 (0) 2071 928338

Participant code: 6293710

 

Webcast link: https://edge.media-server.com/mmc/p/mvia3sy8

 

Enquiries:

 

 Ergomed plc                                              Tel: +44 (0) 1483 402 975
 Miroslav Reljanović (Executive Chairman)
 Richard Barfield (Chief Financial Officer)

 Numis Securities Limited                                Tel: +44 (0) 20 7260 1000
 Freddie Barnfield / Matthew O'Dowd (Nominated Adviser)
 James Black (Broker)

 Consilium Strategic Communications                      Tel: +44 (0) 20 3709 5700
 Chris Gardner / Angela Gray                             ergomed@consilium-comms.com
 Matthew Neal / Olivia Manser

 

 

About Ergomed plc

Ergomed provides specialist services to the pharmaceutical industry spanning
all phases of clinical development, post-approval pharmacovigilance and
medical information. Ergomed's fast-growing services business includes an
industry-leading suite of specialist pharmacovigilance (PV) solutions,
integrated under the PrimeVigilance brand, a full range of high-quality
clinical research and trial management services under the Ergomed brand (CRO),
and an internationally recognised specialist expertise in orphan drug
development, under PSR. For further information, visit: http://ergomedplc.com
(http://ergomedplc.com) .

 

Forward-Looking Statements

 

Certain statements contained within the announcement are forward-looking
statements and are based on current expectations, estimates and projections
about the potential returns of Ergomed plc (Ergomed) and the industry and
markets in which Ergomed operates, the Directors' beliefs and assumptions made
by the Directors. Words such as "expects", "anticipates", "should", "intends",
"plans", "believes", "seeks", "estimates", "projects", "pipeline" and
variations of such words and similar expressions are intended to identify such
forward-looking statements and expectations. These statements are not
guarantees of future performance or the ability to identify and consummate
investments and involve certain risks, uncertainties, outcomes of negotiations
and due diligence and assumptions that are difficult to predict, qualify or
quantify. Therefore, actual outcomes and results may differ materially from
what is expressed in such forward-looking statements or expectations. Among
the factors that could cause actual results to differ materially are: the
general economic climate, competition, interest rate levels, loss of key
personnel, the result of legal and commercial due diligence, the availability
of financing on acceptable terms and changes in the legal or regulatory
environment.

 

These forward-looking statements speak only as of the date of this
announcement. Ergomed expressly disclaims any obligation or undertaking to
disseminate any updates or revisions to any forward-looking statements
contained herein to reflect any change in Ergomed's expectations with regard
thereto, any new information or any change in events, conditions or
circumstances on which any such statements are based, unless required to do so
by law or any appropriate regulatory authority.

 

 

Chairman's Statement

 

EXCEPTIONAL DELIVERY IN CHALLENGING TIMES

 

During 2020 Ergomed made exceptional progress in delivering its strategy,
despite the global challenge of the COVID-19 pandemic. We achieved strong
organic growth and completed acquisitions in the key US market in both our
Clinical Research Services (CRO) and Pharmacovigilance (PV) businesses. Across
the Group we transitioned smoothly to remote working with the business
remaining fully operational whilst continuing to trade strongly and delivering
a strong uplift in revenues in the second half of the year, particularly in
the CRO business. We improved gross and net margins and continued to
strengthen our balance sheet, with increased cash balances and financial
resources, as well as a capital reduction approved unanimously by our
shareholders. During an extraordinary and challenging year, the core strengths
of our business and the hard work and dedication of all our colleagues have
shone through, delivering exceptional progress towards our strategic vision of
global leadership in specialised pharmaceutical services addressing unmet
medical needs and patient safety.

 

Excellent Financial Performance

Following the positive results for the first half of the year reported in
September 2020, Ergomed continued to deliver strong year on year top-line
growth and financial performance across the business in the second half. For
the year as a whole, Ergomed continued its excellent financial performance
delivering substantial revenue growth of 26.5% with improved gross margins.
Adjusted EBITDA increased by 55.2% to £19.4 million, substantially exceeding
the market expectations set at the beginning of the year. After investing
£12.0m on acquisitions, funded fully out of cash, the Group continued to be
debt-free at the year end with cash and equivalent balances of £19.0 million
(2019: £14.3 million) and unutilised banking facilities of £30.0 million. We
ended 2020 with our order book of future contracted revenue at £193.0
million, up 55.5% versus the prior year. This excellent performance in a year
that was extremely challenging for companies across the world, demonstrates
the robustness of Ergomed's business model and firmly positions the Group to
realise its ambitious long-term growth plans.

 

Executing our Strategy

The transition to a fully services-based business model announced in 2018 was
completed on schedule in 2020, with the business now entirely focused on its
core service businesses in the PV and CRO sectors. 2020 saw further validation
of this strategic focus on services, evidenced by significantly improved
financial and operational performance with revenue growth of 26.5% to £86.4
million and strong performances in both PV and CRO. This continued the trend
of a compound annual revenue growth rate of over 20% since the initial public
offering in 2014.

 

Building on these foundations, with the successful execution of our M&A
strategy, rapid integration of acquisitions and alignment of commercial
strategies in our CRO and PV businesses, as well as investment in business
development, we are delivering substantial increases in cross-selling
opportunities and a growing order book of contracted long-term future
revenues.

 

In 2020, we completed two highly strategic acquisitions in the key US market
for pharmaceutical services. In January, we acquired Ashfield
Pharmacovigilance, a long-established and highly respected provider of
pharmacovigilance services in the US. This was rapidly and successfully
integrated, providing cross-selling and growth opportunities within the
significantly expanded PV client base, as evidenced by the Group's US revenue
growth of 82.4% in 2020. In December, we acquired MS Clinical Services, LLC.
and its subsidiaries ('MedSource'), a specialist provider of oncology and rare
disease CRO services, which is expected to provide further growth and
development potential within the key CRO sector in the USA and globally.

 

The Board continues to actively consider further acquisitions that will
complement and strengthen the existing CRO and PV service offerings and give
access to new customers and geographies.

 

We are also continuing to invest in infrastructure, technology and digital
transformation, with the development of applications to achieve significant
automation over the coming years. In our PV business this includes the
development of applications for robotic process automation and the
digitisation of simple adverse event reports, leading to the deployment of
machine learning for full case processing. In the CRO business, we plan to
play a significant role in the global trend, accelerated by COVID-19, towards
digital transformation of clinical trials, including eConsent, ePRO and
wearable technology for remote and home-based patient monitoring as well as
virtual and telemedicine as standard of care, risk-based monitoring and remote
data verification. These investments are expected to build on Ergomed's
leadership position with service offerings to our international client base,
as well as providing further potential for profitability improvement.

 

 

Strong Leadership and Employment Growth

During the year, Ergomed continued to strengthen its executive leadership with
key appointments in Europe and in the US where we are expanding rapidly both
organically and through M&A. Our acquisitions of Ashfield
Pharmacovigilance (now PrimeVigilance USA) and MedSource have included the
addition of key new senior team members. Despite the COVID-19 pandemic,
employment throughout the Group grew from 850 employees to around 1,150 over
the course of 2020.

 

We are delighted to welcome our new colleagues to the Group. These additions
to the Ergomed global team reflect the growing strength and ambition of our
business, add to our high-quality professional experience and strength in
depth and bolster Ergomed's growth potential.

 

COVID-19

The COVID-19 virus outbreak was a dominant factor for global businesses during
2020. Ergomed's response to the pandemic continues to demonstrate the
robustness and resilience of our services business model, which, together with
the hard work and dedication of all our colleagues, has been highlighted
during this challenging year.

 

Health and Safety

Throughout the pandemic, our priority has remained the health and safety of
our employees and the maintenance of our service to all the patients and
medical staff involved in our clinical studies and pharmacovigilance services.

 

We took stringent hygiene measures across all our sites and cancelled
unnecessary travel. Our established business continuity plans enabled the
Group to transition to home working and we continued to provide clinical study
and pharmacovigilance monitoring services in support of all our patients and
medical partners. We saw a temporary reduction in our ability to provide
on-site monitoring services in our CRO business particularly in H1, but
elsewhere there was no impact on our service levels or productivity metrics,
and the quality and scale of the care provided to our patients and the
healthcare profession continued at normal levels.

 

Business Continuity

Ergomed's services in both clinical research and pharmacovigilance are
provided under long-term contracts in order to meet monitoring needs essential
for medical research as well as legally mandated pharmacovigilance
requirements. We have not seen a material COVID-19 impact on our business or
our performance metrics, nor major delays or cancellations to studies or
contracts. The slowdown in monitoring experienced in the CRO business in the
second quarter of 2020 was replaced by a return to growth in the second half
of the year, with revenue higher than in the first half of the year and in the
corresponding period in 2019, as remote monitoring was implemented combined
with a limited return to near normal levels of onsite monitoring in H2. In
addition, our development activities continued in the second half of 2020
providing a strong sales performance and a significant uplift in our order
book at the end of the year.

 

Risk Mitigation

Ergomed maintained a robust financial position throughout the year, with
strong cash generation and substantial cash balances. We continue to monitor
closely the rapidly evolving situation and see no significant immediate risks
to the Group's revenues or operations, however, plans for financial risk
mitigation are in place if necessary. The Group has a strong balance sheet and
an unutilized £30 million credit facility and is continuing to prove
resilient in the face of the risks posed by COVID-19.

 

Our Contribution to the Global Fight Against COVID-19

Ergomed was proud to make an ongoing contribution to the global effort to
overcome the challenges created by the spread of the COVID-19 virus. We
continued to provide our clinical trial and monitoring services for our
existing and new clients and patients to the highest professional standards.

 

At the same time, we provided our clinical research as well as
pharmacovigilance services for new projects designed to combat the virus. A
number of COVID-19 related studies and contracts are continuing, and our
business development pipeline includes significant further opportunities.

 

Conclusion

Ergomed's success in 2020 reflects the resilient business model and robust
position of the business as well as the hard work and dedication of all our
colleagues in a time of exceptional challenge. I would like to thank everyone
at Ergomed for their contribution during the year, and our investors for their
continued support.

 

 

Miroslav Reljanović

Executive Chairman

 

 

 

Operational review

 

INTRODUCTION

In 2020 there was a strong operational and financial performance from both of
the Group's businesses, Pharmacovigilance (PV) and Clinical Research Services
(CRO). We continued to execute our strategy of delivering world-class PV and
CRO services to our customers, whilst fostering business development and
cross-selling opportunities between these two highly complementary businesses.
Despite the challenges of the COVID-19 pandemic, Ergomed demonstrated
resilience and maintained its momentum in 2020. The Group has begun 2021 from
a position of strength, with a robust financial platform and a proven growth
strategy, ensuring that we are well positioned to achieve the longer-term
strategic priorities of the business.

 

PHARMACOVIGILANCE

Regulatory context

The increasing global requirement for pharmacovigilance services coupled with
a perpetual drive to improve drug safety through regulation continue to
facilitate the transition towards specialist outsourced PV providers and
general market growth.

 

In Europe, the implementation of Good Pharmacovigilance Practice ('GPvP') in
2012 and subsequent mandatory compliance has led to an increased demand for
outsourced PV services and been a consistent driver for Ergomed's growth. In
the US, the existing stringent PV regulatory regime continues to be regularly
strengthened on an ongoing basis. Similarly, PV regulation continues to be
rolled out in the Middle East, China and South East Asia, providing further
growth opportunities for Ergomed's PV business. Ergomed intends to continue to
leverage existing partnerships in these regions to facilitate growth and meet
client requirements.

 

The latest regulation to affect Europe is Brexit, as a result of which the UK
will no longer fall under the EU GPvP jurisdiction. This is expected to add
regulatory complexity and drive further demand for specialist outsourced PV
services.

 

Acquisition of Ashfield Pharmacovigilance

In January 2020 PrimeVigilance, Ergomed's pharmacovigilance business, welcomed
the addition of Ashfield Pharmacovigilance ('Ashfield PV'), an established PV
provider in North America, into the Group. Ashfield PV was immediately
rebranded as PrimeVigilance USA Inc. ('PV USA') and, through its rapid
integration into the Group, significantly expanded Ergomed's PV offering in
North America.

 

The acquisition immediately saw the addition of around 70 highly qualified and
experienced staff, 40 new clients and around $12 million of annual revenue
from this strategically important market. Since then, the operational and
administrative functions of PV USA have been fully integrated into the wider
Group and we have already seen the benefits of the acquisition through
increased economies of scale and cross-selling opportunities. The hard work
and dedication of all the Ashfield and PrimeVigilance staff was key to making
this business combination as successful as it has been to date.

 

Financial Performance

The addition of PV USA and the strong organic growth of the PV business saw
revenues increase by £19.7 million from £35.4 million in 2019 to £55.1
million in 2020 (55.6% increase) of which £9.3 million was due to the
addition of PV USA. Margins continued to be strong for the PV business
increasing from 51.5% in 2019 to 52.0% in 2020.

 

Sales Awards and Order Book

PV new business in 2020 was primarily driven by North America which accounted
for 90% of repeat business and 72% of new business. The contracted order book
grew from £54.6 million in 2019 to £79.8 million at the end of 2020, an
increase of 46.2%.

 

Management and Staff

In addition to the acquisition of Ashfield, the business continued to invest
in its employees to support its geographical expansion, with over 250
employees being promoted during the year. PrimeVigilance employs around 50
physicians, over 300 pharmacists and other life sciences professionals and
over 20 in-house EU Qualified Persons for Pharmacovigilance ('QPPVs') covering
more than 60 countries. This constitutes one of the largest qualified teams of
PV specialist professionals in any independent pharmaceutical services
business globally and it continues to grow. The breadth and depth of staff and
professionals supporting PrimeVigilance is reflected in the quality of
services provided. Testament to this is PrimeVigilance's high customer renewal
and retention figures and the fact that PrimeVigilance participated in over 70
regulatory inspections with no critical findings relating to its activities.

 

Technology Investment

Investment in technology is at the core of the PrimeVigilance quality first
approach. During the year the business, in partnership with DataRobot and
Automation Anywhere, commenced the development of a cloud-based solution to
automate certain PV processes, allowing faster analysis and reporting of
adverse medical events.

 

The technology is expected to bring new levels of speed and intelligence to a
key activity of the business, freeing up valuable hours for highly trained
pharmacovigilance professionals to focus on value creation and problem solving
that only humans can address, and helping to deliver a higher quality service
more efficiently. The PV business is also consolidating its safety databases
into a single cloud-based platform, which will drive further efficiencies.

 

Constantly evolving regulations, geographic expansion, investment in
technology and people, combined with the strength of the PrimeVigilance brand,
mean that the PV business is well placed to continue delivering its growth
strategy into 2021 and beyond.

 

CLINICAL RESEARCH SERVICES

Ergomed delivers high-quality clinical research services through a
comprehensive offering of clinical trial research support services covering
all phases of medical development via a global network of research experts and
patients.

 

The CRO market has experienced significant expansion with high annual growth
in oncology and rare disease research expected to continue over the coming
years. This specific growth in Ergomed's core focus areas is underpinned by
broader market trends including increased investment in drug development by
pharma-biotech companies, a shift towards clinical trial outsourcing and
strong growth in the number of trials in markets such as Asia.

 

COVID-19

COVID-19 caused significant disruption to the global CRO market during 2020.
Restrictions on movement meant that access to patients for physical monitoring
visits was limited, with some leading listed CROs reporting restricted site
access in 50% to 80% of trials at the pandemic peak.

 

Despite these disruptions, Ergomed's CRO business demonstrated robustness and
resilience during the pandemic. While the pandemic peak did impact some of our
clinical studies, clinical trials in rare disease and oncology, in which
Ergomed specialises, are focused on critical unmet needs and were therefore
among the therapeutic areas least disrupted by COVID-19. Restrictions on
movement and patient access accelerated the trend towards remote monitoring,
an area which Ergomed was already pioneering. During the pandemic, Ergomed
successfully implemented remote and risk-based monitoring techniques, allowing
clinical trial activities to continue even when physical access to sites was
not possible. For early phase studies where frequent and timely monitoring of
safety and tolerability is required, Ergomed implemented patient profile
software that provides a holistic view of each patient in an interactive and
real time environment. In addition, study physicians supported trial
investigators in patient identification and procedures resulting in consistent
patient recruitment and milestone achievement.

 

Financial Performance

Overall the CRO business saw total revenues flat at £31.3 million year on
year (2019: £31.2 million after adjusting for exceptional revenues of £1.6
million in 2019). This included an increase in service fee revenue of £1.0
million to £23.7 million, offset by a decline of £0.9 million in zero-margin
pass-through revenue to £7.6 million. There was also an increase in third
party full-margin service fee revenue (excluding co-development) from £18.3
million to £21.5 million, an increase of 17.5%, with almost all
co-development projects having now concluded. As a result of these positive
trends, the service fee gross margin in the CRO business grew by 3.7ppts from
42.6% to 46.3%, highlighting the underlying strength of the CRO business and
resilience to the pandemic. It is also notable that in H2 2020, the CRO
business resumed growth with service fee revenues increasing by 13.5% compared
to the first half of the year.

 

Acquisition of MS Clinical Services LLC. and its subsidiaries ('MedSource')

In December 2020, Ergomed was pleased to announce the acquisition of
MedSource, a US-based CRO business with over 20 years' experience in
delivering specialist oncology and rare disease clinical trial services.
MedSource further strengthens Ergomed's position as a high-quality oncology
and rare disease CRO provider in the strategically important North American
market. With the acquisition of MedSource, the Group welcomed the addition of
110 highly qualified staff, primarily based in the US, and 20 new clients. The
work of integrating the business has already started as the Group looks to
expand its offering in North America and build upon the success in 2020 which
saw 65% of Ergomed's CRO repeat business wins in this region.

 

Sales Awards and Order Book

The CRO contract order book grew from £69.5 million in 2019 to £113.2m
million in 2020. The combined total order book gives the Group excellent
visibility on the rollout of revenue during 2021 and confidence in delivering
its strategy of growth.

 

Rare Disease and Oncology Focus

Ergomed's CRO business works across all therapeutic areas, as a differentiated
provider of clinical trial services with a particular strength in patient
recruitment in oncology and rare disease trials. Oncology trials are generally
very complex, although this varies with the type of cancer, and studies are
often confronted by challenges including low patient enrolment, changing
regulatory requirements, increased research costs, and trial protocols with
increased study-related procedures. This explains in part why oncology trials
are the biggest recipients of funding and makes the case for outsourcing to
CROs who are better positioned to address these challenges. Ergomed's
expertise and focus on oncology supports its CRO growth strategy and is
evidenced by the fact that 88% (by value) of new business wins in 2020 related
to oncology and rare disease, where similarly specialist expertise is also
required.

 

Patient and Clinician Focus

Ergomed's focus on rare and orphan drug development is one of its core
strengths. Drug development for rare and orphan diseases is challenging for
many reasons, including complex biology, limited knowledge of the history and
progression of the disease and the inherently small patient population
available for clinical trials, who are usually geographically dispersed.
Ergomed's focus on physician support teams helps ensure efficient patient
recruitment, patient retention and clinical trial management of complex
studies. Through the PSR Orphan Expert brand and the recent addition of
MedSource, Ergomed distinguishes itself from peers in the market.

 

With the addition of MedSource and the continuing focus on patient needs, the
CRO business is well placed to deliver on its growth strategy in 2021. There
is an increasing need to draw on patient knowledge and experience to improve
the discovery, development and evaluation of new effective medicines. In
addition, greater patient engagement optimises clinical study design, outcome
measures and endpoint development. Ergomed maintains a Patient Organisation
Advisory Board, comprising of representatives of patient groups in the field
of rare diseases and has a dedicated Patient Engagement Officer.

 

BUSINESS DEVELOPMENT AND COMMERCIAL INTEGRATION

A strong business development performance in 2020 resulted in sales increasing
by 41.9% to £117.8 million (2019: £83.0 million). This included significant
levels of new awards due to effective cross-selling between the CRO and PV
businesses, bolstered by the addition of Ashfield PV in the USA (now
PrimeVigilance USA). In 2020 total cross-selling awards were £8.6 million,
with over £50 million of further opportunities in the business development
pipeline at the end of the year. Key to new contract wins in both CRO and PV
services was Ergomed's broader geographic footprint arising from organic
expansion into the USA and Asia, as well as its ability to offer increased
services and broader geographic coverage to the newly acquired PrimeVigilance
USA client base. As a result, the order book increased to £193.0 million at
the year end, up 55.5% over the course of 2020.

 

OUTLOOK

Ergomed made exceptional progress in delivering its strategy in 2020, despite
the challenges of the COVID-19 pandemic. The resilience and robustness of our
global services business was demonstrated by our continued strong organic
growth whilst completing key strategic acquisitions in the US in both our
pharmacovigilance and CRO businesses. We have started 2021 in a strong
position focused on our vision to achieve global leadership in specialised
pharmaceutical services addressing unmet medical needs and patient safety.

 

For and on behalf of the Board of Directors

 

 

Miroslav Reljanović

Executive Chairman

 

 

 

Financial Review

 

Introduction

 

Ergomed's financial performance was strong in 2020 with market expectations
upgraded on a number of occasions. With the transition to a fully
services-based business model now largely complete, the Group's complementary
CRO and PV divisions continued to trade strongly despite the impact of the
pandemic. Gross and net margins continued to improve throughout the year. This
was in part due to effective cost control both at the cost of sales and
general and administration levels, coupled with the successful integration of
recent acquisitions and continuing investment in technology. Effective
management of working capital and the new £30.0 million credit facility
established in March 2020, which remains undrawn, also contributed to the
overall strong financial position of the Group. The balance sheet has been
further strengthened by the elimination of exposure to previous co-development
investments. The capital reduction, approved unanimously by the Group's
shareholders in October 2020, together with significantly increased
profitability in the past two years, have increased the Group's consolidated
retained earnings by over £50 million.

 

KPIs and APMs

Key Performance Indicators (KPIs)

The table below summarizes the KPIs that management uses to measure the
financial performance of the Group.

 £ millions (unless otherwise stated)   2020               2019
 Total Revenue                          86.4               68.3
 CRO (Note 1)                           31.3               31.2
 PV                                            55.1        35.4
 Gross profit                           39.7               29.5
 Gross margin                           45.9%              43.3%
 EBITDA                                 18.4               9.2
 Adjusted EBITDA                        19.4               12.5
 Basic adjusted earnings per share      25.8p              19.9p
 Cash generated from operations         19.0               11.7
 Cash and cash equivalents              19.0               14.3
 Order book                             193.0              124.1

 

Note 1: CRO Revenue in 2019 is stated after adjustment for exceptional
revenues of £1.6 million.

 

Alternative performance measures (APMs)

 

In measuring and reporting financial information, management reviews
Alternative Performance Measures (APMs), such as EBITDA, adjusted EBITDA and
basic adjusted earnings per share, which are not defined measures under
financial reporting standards. Management believes that these measures, when
considered in conjunction with defined financial reporting measures, provide
management and stakeholders with a broader understanding of the performance of
the business.

 

Operating profit is the financial reporting measure under IFRS most comparable
to EBITDA and adjusted EBITDA. The Directors make certain adjustments to
EBITDA to derive adjusted EBITDA, which they consider more reflective of the
Group's underlying trading performance, enabling comparisons to be made with
prior periods. Certain items, such as share-based payments and change in fair
value of contingent consideration for acquisitions are non-cash items and
reflect adjustments to expected future consideration payments.

 

Operating profit is reconciled to EBITDA and adjusted EBITDA as follows:

                                                                            2020      2019

                                                                            £000's    £000's
 Operating profit                                                           13,534    5,517
 Adjusted for:
 Depreciation and amortisation charges within Other selling, general &      3,511     3,041
 administration expenses
 Amortisation of acquired fair valued intangible assets                     1,332     671
 EBITDA                                                                     18,377    9,229
 Adjusted for:
 Share-based payment charge                                                 742       870
 Acquisition related contingent compensation                                -         87
 Change in fair value of contingent consideration for acquisitions          -         (512)
 RDEC income (2017)                                                         (527)     -
 Grants in recognition of employment creation in Serbia                     (307)     -
 Acquisition costs                                                          853       393
 Pay in lieu and non-compete compensation                                   232       -
 Exceptional items                                                          -         2,427
 Adjusted EBITDA                                                            19,370    12,494

 

Acquisition-related contingent compensation relates to the cash component of
deferred consideration which is payable contingent on the continued employment
of the vendors. These costs, together with acquisition costs, pay in lieu and
non-compete compensation and exceptional items, are cash costs but are not
considered as normal recurring trading items and therefore are not included in
adjusted EBITDA. RDEC income in relation to 2017 and grants received are not
considered as normal recurring trading items and therefore are not included in
adjusted EBITDA.

Adjusted basic earnings per share is calculated on a similar basis to basic
earnings per share but uses a profit measure which, like adjusted EBITDA, is
adjusted for non-recurring income items (see note 8 of the financial
statements).

Management has previously used order book, (referred to in prior years as
contracted order backlog) as an APM. Order book is the contracted value of
customer revenue relating to in-progress performance obligations which are
expected to be recognised in the future. The use of order book by management
is no longer considered to be an APM as, from 1 January 2018, it is now a
defined financial measure under IFRS 15 and is therefore included in KPIs.

 

Growth

Ergomed's CRO and PV businesses both continued to show positive revenue
performance through to year-end, resulting in a strong order book to start
2021.

 

Revenues for 2020 totalled £86.4 million, an increase of 26.5% over the prior
year (2019: £68.3 million). CRO revenues were flat at £31.3 million (2019:
£31.2 million after adjusting for exceptional revenues of £1.6 million),
with the wider CRO sector experiencing challenges in the wake of the pandemic.
PV revenues increased 55.6% from £35.4 million to £55.1 million including
£9.3 million due to the addition of PV USA.

 

The 26.5% revenue growth overall was accompanied by a 34.6% increase in gross
profit from £29.5 million in 2019 to £39.7 million in 2020, with gross
margin increasing from 43.3% in 2019 to 45.9% in 2020 as a result of effective
cost controls at the cost of sales level.

 

The Group also concluded most of its co-development projects, in line with the
strategy to focus on the services-based model in both PV and CRO. As a result,
the Group has reduced its overall R&D expenditure from £0.5 million in
2019 to £0.2 million in 2020. Having recognised realised impairment charges
and write-offs totalling £2.4 million as exceptional costs related to this
strategic focus in 2019, there were no exceptional charges in 2020. Ongoing
costs required to exercise prudent stewardship over the co-development assets
are not expected to be material.

 

In 2020 the significant revenue growth, profitability focus and effective cost
management resulted in an adjusted EBITDA of £19.4 million, an increase of
55.2% over the prior year (2019: £12.5 million).

 

Financial strength

The growth in revenue and profitability achieved during 2020 led to strong
cash generation at an operating level. Cash generated from operations was
£19.0 million, an increase of £7.3 million over the prior year (2019: £11.7
million). The cash generated represented 99.0% of adjusted EBITDA and
demonstrated the strong cash conversion capabilities of the business.

The Group continues to strengthen its balance sheet, with cash and cash
equivalents increasing by £4.7 million to £19.0 million at the year-end
(2019: £14.3 million). This was after net cash outflows on the acquisitions
of Ashfield Pharmacovigilance in January 2020 of £7.6 million and MedSource
in December 2020 of £4.4 million. In March 2020 as a precautionary measure
taken during the initial phase of the COVID-19 pandemic, £15.0 million cash
was drawn down on the Group's £30.0 million credit facility established in
March 2020 with the Group's banking partner, HSBC UK Bank plc. This cash was
held in the bank and remained unutilised until it was repaid in full in August
2020.

In October 2020, a capital reduction was unanimously approved by shareholders,
whereby the amounts of £27.6 million standing to the credit of the share
premium account and £11.1 million standing to the credit of the merger
reserve were cancelled and the balances were transferred to the retained
earnings account. As a result of this and the generation of distributable
reserves, the consolidated retained earnings account of the Group stood at
£45.4 million at the end of 2020.

Ergomed plc has a strong balance sheet with net assets as of 31 December 2020
of £52.9 million up 43.8% on prior year (2019: £36.8 million) which includes
cash and cash equivalents of £19.0 million (2019: £14.3 million) within
total assets of £92.3 million (2019: £57.0 million). Consolidated retained
earnings of the Group at the year-end were £45.4 million, an increase of
£50.9 million over the retained earnings deficit of £5.5 million reported in
2019.

Outlook

A strong financial foundation is now in place to continue to support the Group
on a steady course beyond the COVID-19 pandemic. Ergomed is well placed to
trade strongly into new opportunities for organic growth and expansion through
M&A activity.

 

 

Richard Barfield

Chief Financial Officer

 

 

 

Consolidated income statement

For the year ended 31 December 2020

                                                                           Notes  2020      2019

                                                                                  £000s     £000s
 Revenue                                                                   2, 3   86,391    68,255
 Cost of sales                                                                    (38,686)  (29,790)
 Reimbursable expenses                                                            (8,055)   (8,940)
 Gross profit                                                              3      39,650    29,525
 Selling, general and administration expenses                                     (27,518)  (23,514)
  Selling, general and administration expenses comprises:
  Other selling, general and administration expenses                              (24,591)  (19,578)
  Amortisation of acquired fair valued intangible assets                          (1,332)   (671)
  Share-based payment charge                                                      (742)     (870)
  Acquisition-related contingent compensation                                     -         (87)
  Change in the fair value of contingent consideration for acquisitions           -         512
  Acquisition costs                                                        4      (853)     (393)
  Exceptional items                                                        5      -         (2,427)
 Research and development expenses                                                (152)     (545)
 Net impairment losses on trade receivables and contract assets                   (285)     -
 Other operating income                                                    6      1,839     51
 Operating profit                                                                 13,534    5,517
 Finance income                                                                   8         28
 Change in fair value of equity investments                                12     (511)     (286)
 Finance costs                                                             7      (403)     (273)
 Profit before taxation                                                           12,628    4,986
 Taxation                                                                         (2,946)   583
 Profit for the year                                                              9,682     5,569

 

 

All activities in the current and prior period relate to continuing
operations.

 

The accompanying notes form an integral part of these financial statements.

 

 

 

Consolidated statement of comprehensive income

For the year ended 31 December 2020

                                                               2020     2019

                                                               £000s    £000s
 Profit for the year                                           9,682    5,569
 Items that may be classified subsequently to profit or loss:
 Exchange differences on translation of foreign operations     (59)     (208)
 Other comprehensive (loss) for the year net of tax            (59)     (208)
 Total comprehensive profit for the year                       9,623    5,361

 

 

Profit or loss and each component of other comprehensive income are
attributable to the owners of the Company.

 

 

 Earnings Per Share (EPS)  8  2020    2019

                              pence   pence
 Basic                        20.0    12.0
 Diluted                      19.2    11.5

 

 

Unaudited

 Adjusted Earnings Before Interest, Tax, Depreciation and Amortisation     2020     2019

 (Adjusted EBITDA)                                                         £000s    £000s
 Adjusted EBITDA                                                        9  19,370   12,494

 

 

Unaudited

 Adjusted Earnings Per Share (Adjusted EPS)  8  2020    2019

                                                pence   pence
 Basic                                          25.8    19.9
 Diluted                                        24.7    19.1

 

 

The accompanying notes form an integral part of these financial statements.

 

 

 

Consolidated balance sheet

As at 31 December 2020

                                Notes  2020      2019

                                       £000s     £000s
 Non-current assets
 Goodwill                       10     24,605    13,380
 Other intangible assets        11     9,618     2,755
 Property, plant and equipment         1,742     1,110
 Right-of-use assets                   4,715     5,171
 Equity investments             12     -         -
 Deferred tax asset                    4,898     2,616
                                       45,578    25,032
 Current assets
 Trade and other receivables    13     22,224    14,359
 Accrued revenue                       5,553     3,382
 Cash and cash equivalents      14     18,994    14,259
                                       46,771    32,000
 Total assets                          92,349    57,032
 Current liabilities
 Lease liabilities                     (1,978)   (1,718)
 Trade and other payables       15     (15,702)  (10,373)
 Deferred consideration                (328)     -
 Deferred revenue                      (13,829)  (2,957)
 Current tax liability                 (1,775)   (813)
                                       (33,612)  (15,861)
 Net current assets                    13,159    16,139
 Non-current liabilities
 Lease liabilities                     (3,128)   (3,716)
 Provisions                            (317)     (341)
 Deferred tax liability                (2,426)   (294)
                                       (5,871)   (4,351)
 Total liabilities                     (39.483)  (20,212)
 Net assets                            52,866    36,820
 Equity
 Share capital                  16     489       473
 Share premium account          16     3         25,790
 Merger reserve                 16     1,349     11,088
 Share-based payment reserve           5,042     4,300
 Translation reserve                   615       674
 Retained earnings                     45,368    (5,505)
 Total equity                          52,866    36,820

 

 

The accompanying notes form an integral part of these financial statements.

 

 

 

Consolidated statement of changes in equity

For the year ended 31 December 2020

                                                          Notes  Share     Share     Merger    Share-    Translation  Retained   Total equity

                                                                 capital   premium   reserve   based     reserve      earnings   £000s

                                                                 £000s     account   £000s     payment   £000s        £000s

                                                                           £000s               reserve

                                                                                               £000s
 Balance at 1 January 2019                                       452       24,384    11,088    3,430     882          (11,873)   28,363
 Profit for the year                                             -         -         -         -         -            5,569      5,569
 Other comprehensive income for the year                         -         -         -         -         (208)        -          (208)
 Total comprehensive income                                      -         -         -         -         (208)        5,569      5,361
 Transactions with shareholders
 Shares issued during the year for cash                   16     21        1,406     -         -         -            -          1,427
 Share-based payment charge for the year                         -         -         -         870       -            -          870
 Deferred tax credit taken directly to equity                    -         -         -         -         -            799        799
 Total transactions with shareholders                            21        1,406     -         870       -            799        3,096
 Balance at 31 December 2019                                     473       25,790    11,088    4,300     674          (5,505)    36,820
 Profit for the year                                             -         -         -         -         -            9,682      9,682
 Other comprehensive income for the year                         -         -         -         -         (59)         -          (59)
 Total comprehensive income                                      -         -         -         -         (59)         9,682      9,623
 Transactions with shareholders
 Shares issued during the year for cash                   16     14        1,855     -         -         -            -          1,869
 Share-based payment charge for the year                         -         -         -         742       -            -          742
 Deferred tax credit taken directly to equity                    -         -         -         -         -            2,461      2,461
 Shares issued for non-cash consideration                 16     2         -         1,349     -         -            -          1,351
 Transactions with shareholders - Capital Reduction       16
 Capitalisation of Merger reserve to 'B' Ordinary Shares  16     11,088    -         (11,088)  -         -            -          -
 Cancellation of 'B' Ordinary Shares                      16     (11,088)  -         -         -         -            11,088     -
 Cancellation of Share Premium                            16     -         (27,642)  -         -         -            27,642     -
 Total transactions with shareholders                            16        (25,787)  (9,739)   742       -            41,191     6,423
 Balance at 31 December 2020                                     489       3         1,349     5,042     615          45,368     52,866

 

 

The accompanying notes form an integral part of these financial statements.

 

 

Consolidated cash flow statement

For the year ended 31 December 2020

                                                                           Notes  2020      2019

                                                                                  £000s     £000s
 Cash flows from operating activities
 Profit before taxation                                                           12,628    4,986
 Adjustment for:
 Amortisation and depreciation                                                    4,843     3,712
 Impairment of goodwill, intangibles, equity investments and other assets  5      -         2,427
 Loss on disposal of fixed assets                                                 16        25
 Share-based payment charge                                                       742       870
 Change in the fair value of equity investments                            12     511       286
 Change in the fair value of contingent consideration for acquisition             -         (512)
 RDEC income                                                               6      (1,188)   -
 Finance income                                                                   (8)       (28)
 Finance costs                                                             7      403       273
 Operating cash inflow before changes in working capital and provisions           17,947    12,039
 (Increase)/decrease in trade, other receivables and accrued revenue              (6,137)   1,878
 Increase/(decrease) in trade, other payables and deferred revenue                7,182     (2,380)
 (Decrease)/increase in provisions                                                (18)      126
 Cash generated from operations                                                   18,974    11,663
 Taxation (paid)/received                                                         (926)     124
 Net cash inflow from operating activities                                        18,048    11,787
 Investing activities
 Interest received                                                                8         7
 Acquisition of intangible assets                                          11     (542)     (604)
 Acquisition of property, plant and equipment                                     (432)     (392)
 Receipts from sale of property, plant and equipment                              46        8
 Equity investments received in exchange for services provided             12     -         (1,904)
 Receipts from the sale of equity investments                              12     175       1,099
 Acquisition of subsidiaries, net of cash acquired                         17,18  (12,031)  (115)
 Acquisition related earn-out paid                                                -         (930)
 Net cash outflow from investing activities                                       (12,776)  (2,831)
 Financing activities
 Issue of new shares                                                       16     1,869     1,427
 Finance costs paid                                                               (157)     -
 Proceeds from borrowings                                                  14     15,000    -
 Repayment of borrowings                                                   14     (15,000)  -
 Payment of lease liabilities                                                     (2,189)   (1,677)
 Net cash outflow from financing activities                                       (477)     (250)
 Net change in cash and cash equivalents                                          4,795     8,706
 Effect of foreign currency on cash balances                                      (60)      364
 Cash and cash equivalents at start of year                                       14,259    5,189
 Cash and cash equivalents at end of year                                  14     18,994    14,259

 

The accompanying notes form an integral part of these financial statements.

 

 

Notes to the Financial Statements

For the year ended 31 December 2020

 

1. Basis of preparation

The consolidated financial statements of the Group have been prepared on the
going concern basis in accordance with international accounting standards in
conformity with the requirements of the Companies Act 2006, the IFRS
Interpretations Committee ('IFRS-IC') interpretations and those parts of the
Companies Act 2006 applicable to companies reporting under IFRS.

The consolidated financial statements have been prepared on a historical cost
basis except that the following assets and liabilities are stated at their
fair value: certain financial assets and financial liabilities measured at
fair value, and liabilities for cash-settled share‑based payments.

The same accounting policies, presentation and methods of computation have
been followed in these condensed financial statements as were applied in the
preparation of the Group's financial statements for the year ended 31 December
2020.

The financial statements for 2019 have been delivered to the Registrar of
Companies and the 2020 financial statements will be delivered after the Annual
General Meeting on 10 June 2021.

The Auditor has reported on both sets of accounts without qualification, did
not draw attention to any matters by way of emphasis without qualifying their
report, and did not issue a statement under Section 498(2) or 498(3) of the
Companies Act 2006.

Except as described below, the accounting policies adopted are consistent with
those of the financial statements for the year ended 31 December 2019, as
described in those financial statements.

 

Going concern

The financial statements have been prepared on the going concern basis, which
assumes that the Group and Company will have sufficient funds to continue in
operational existence for the foreseeable future, being a period of no less
than 12 months from the date of signing of the financial statements. The
Directors have reviewed a cash flow forecast for the period 31 December 2023,
which is derived from the 2021 Board approved budget and a medium-term cash
flow forecast through to 31 December 2023, which is an extrapolation of the
approved budget under multiple scenarios and growth rates. The 2021 budget and
medium‑term forecast represents the Directors' best estimate of the Group's
future performance and necessarily includes a number of assumptions, including
the level of revenues. The 2021 budget and medium-term forecast demonstrate
that the Directors have a reasonable expectation that the Group will be able
to meet its liabilities as they fall due for a period of at least 12 months
from the date of approval of the financial statements.

 

On the basis of the above factors and, having made appropriate enquiries, the
Directors have a reasonable expectation that the Company and Group have
adequate resources to continue in operational existence for the foreseeable
future. Accordingly, they continue to adopt the going concern basis in
preparing these financial statements.

 

2. Revenue

The Group's revenue is disaggregated by geographical market and major service
lines:

 

Geographical market and major service lines

2020

                                         Major service lines
                                         CRO      PV       Total

                                         £000s    £000s    £000s
 Geographical market by client location
 UK                                      3,589    8,590    12,179
 Rest of Europe, Middle East and Africa  10,146   13,183   23,329
 North America                           15,828   30,836   46,664
 Asia                                    1,753    2,269    4,022
 Australia                               -        197      197
                                         31,316   55,075   86,391

 

2019

                                         Major service lines
                                         CRO      PV       Total

                                         £000s    £000s    £000s
 Geographical market by client location
 UK                                      5,096    7,590    12,686
 Rest of Europe, Middle East and Africa  17,427   10,910   28,337
 North America                           9,245    16,337   25,582
 Asia                                    1,064    445      1,509
 Australia                               10       131      141
                                         32,842   35,413   68,255

 

 

3. Operating segments

Products and services from which reportable segments derive their revenues

Information reported to the Company's Board, which is the chief operating
decision maker ('CODM'), for the purpose of resource allocation and assessment
of segment performance, is focused on the Group operating as two business
segments, being Clinical Research Services ('CRO') and Pharmacovigilance
('PV'). All revenues arise from direct sales to customers. The segment
information reported below all relates to continuing operations. The PV
segment includes the revenues of Ashfield Pharmacovigilance Inc. ('Ashfield')
following its acquisition by the Group in the year. The CRO segment includes
the revenues of MS Clinical Services, LLC. and its subsidiaries ('MedSource')
following its acquisition by the Group in the year.

 

The accounting policies of the reportable segments are the same as the Group's
accounting policies. Segment profit represents the gross profit earned by each
segment. Other amounts, including selling, general and administration expenses
were not allocated to a segment. This was the measure reported to the CODM for
the purpose of resource allocation and assessment of segment performance.

 

2020

                                                             CRO       PV        Consolidated

                                                             £000s     £000s     total

                                                                                 £000s
 Segment revenues                                            31,316    55,075    86,391
 Cost of sales                                               (12,737)  (25,949)  (38,686)
 Reimbursable expenses                                       (7,584)   (471)     (8,055)
 Segment gross profit                                        10,995    28,655    39,650
 Selling, general and administration expenses                                    (27,518)
  Selling, general and administration expenses comprises:
  Other selling, general and administration expenses                             (24,591)
  Amortisation of acquired fair valued intangible assets                         (1,332)
  Share-based payment charge                                                     (742)
  Acquisition costs                                                              (853)
 Research and development expenses                                               (152)
 Net impairment of trade receivables and contract assets                         (285)
 Other operating income                                                          1,839
 Operating profit                                                                13,534
 Finance income                                                                  8
 Change in fair value of equity investments                                      (511)
 Finance costs                                                                   (403)
 Profit before tax                                                               12,628

 

 

2019

                                                                           CRO       PV        Consolidated

                                                                           £000s     £000s     total

                                                                                               £000s
 Segment revenues                                                          32,842    35,413    68,255
 Cost of sales                                                             (13,045)  (16,745)  (29,790)
 Reimbursable expenses                                                     (8,498)   (442)     (8,940)
 Segment gross profit                                                      11,299    18,226    29,525
 Selling, general and administration expenses                                                  (23,514)
  Selling, general and administration expenses comprises:
  Other selling, general and administration expenses                                           (19,578)
  Amortisation of acquired fair valued intangible assets                                       (671)
  Share-based payment charge                                                                   (870)
  Acquisition-related contingent compensation                                                  (87)
  Change in the fair value of contingent consideration for acquisitions                        512
  Acquisition costs                                                                            (393)
  Exceptional items                                                                            (2,427)
 Research and development expenses                                                             (545)
 Other operating income                                                                        51
 Operating profit                                                                              5,517
 Finance income                                                                                28
 Change in fair value of equity investments                                                    (286)
 Finance costs                                                                                 (273)
 Profit before tax                                                                             4,986

 

 

4. Acquisition costs

                                            2020     2019

                                            £000s    £000s
 Acquisition of Ashfield Pharmacovigilance  14       393
 Acquisition of MedSource                   825      -
 Other acquisition costs                    14       -
                                            853      393

 

 

5. Exceptional items

Exceptional items

In line with the way the Board and chief operating decision maker review the
business, large one-off exceptional costs are shown as exceptional items.

 

                                  2020     2019

                                  £000s    £000s
 Impairment of equity investment  -        2,427

 

During the year ended 31 December 2019, the fair value equity investment in
Modus Therapeutics Holding AB was impaired to £nil resulting in a charge to
exceptional items of £2,427,000 (see note 12).

 

 

6. Other operating income

Research and Development Expenditure Credit (RDEC)

The Group is eligible, within the UK, to claim tax credits against certain
research and development expenditure under the RDEC scheme. During the year
the Group submitted claims in respect of the 2017 and 2018 financial years and
recognised the related profit and loss charge within other operating income in
the current financial year.

 

                       2020     2019

                       £000s    £000s
 Foreign grant income  574      -
 RDEC income           1,188    -
 Other income          77       51
                       1,839    51

 

7. Finance costs

                                  2020     2019

                                  £000s    £000s
 Loan and other interest payable  158      13
 Interest on lease liabilities    245      260
                                  403      273

 

 

8. Earnings per share

The calculation of the basic and diluted earnings per share is based on the
following data:

 

 Earnings                                                                       2020     2019

                                                                                £000s    £000s
 Profit for the purposes of earnings per share - net profit attributable to     9,682    5,569
 owners of the Company
 Adjust for:
 Amortisation of acquired fair valued intangible assets                         1,332    671
 Share-based payment charge                                                     742      870
 Acquisition-related contingent consideration                                   -        87
 Change in fair value of contingent consideration for acquisitions              -        (512)
 Acquisition costs                                                              853      393
 Exceptional items                                                              -        2,427
 Pay in lieu and non-compete compensation                                       232      -
 Change in fair value of equity investments                                     511      286
 RDEC income (2017)                                                             (527)    -
 Grants in recognition of employment creation in Serbia                         (307)    -
 Tax effect of adjusting items                                                  (41)     (509)
 Adjusted earnings for the purposes of adjusted earnings per share (Unaudited)  12,477   9,282

 

 Number of shares                                                               2020        2019

                                                                                Number      Number
 Weighted average number of Ordinary Shares for the purposes of basic earnings  48,323,814  46,599,917
 per share
 Incremental shares in respect of employee share schemes                        2,176,170   2,027,154
 Weighted average number of Ordinary Shares for the purposes of diluted         50,499,984  48,627,071
 earnings per share

 

 

 Earnings per share (EPS)  2020    2019

                           pence   pence
 Basic                     20.0    12.0
 Diluted                   19.2    11.5

 

Unaudited

 Adjusted earnings per share (Adjusted EPS)  2020    2019

                                             pence   pence
 Basic                                       25.8    19.9
 Diluted                                     24.7    19.1

 

 

 

9. EBITDA and Adjusted EBITDA

 Unaudited                                                                  2020      2019

                                                                            £000's    £000's
 Operating profit                                                           13,534    5,517
 Adjusted for:
 Depreciation and amortisation charges within Other selling, general &      3,511     3,041
 administration expenses
 Amortisation of acquired fair valued intangible assets                     1,332     671
 EBITDA                                                                     18,377    9,229
 Adjusted for:
 Share-based payment charge                                                 742       870
 Acquisition related contingent compensation                                -         87
 Change in fair value of contingent consideration for acquisitions          -         (512)
 RDEC income (2017)                                                         (527)     -
 Grants in recognition of employment creation in Serbia                     (307)     -
 Acquisition costs (note 4)                                                 853       393
 Pay in lieu and non-compete compensation                                   232       -
 Exceptional items (note 5)                                                 -         2,427
 Adjusted EBITDA                                                            19,370    12,494

 

10. Goodwill

 Cost                              £000s
 At 1 January 2019                 15,802
 Translation movement              (279)
 At 31 December 2019               15,523
 Arising on business combinations  11,261
 Translation movement              (36)
 At 31 December 2020               26,748
 Impairment provision
 At 1 January 2019 and 2020        2,143
 At 31 December 2019 and 2020      2,143
 Net book value
 At 31 December 2020               24,605
 At 31 December 2019               13,380

 

 

The goodwill arising during the year ended 31 December 2020 relates to the
acquisitions of Ashfield Pharmacovigilance Inc. ('Ashfield') (note 17) and MS
Clinical Services, LLC. and its subsidiaries ('MedSource') (note 18).

 

Goodwill acquired in a business combination is allocated, at acquisition, to
the cash-generating units ('CGUs') that are expected to benefit from that
business combination. The carrying amount of goodwill has been allocated as
follows:

 

 Cash-generating unit  2020     2019

                       £000s    £000s
 CRO                   10,859   3,535
 PV                    13,746   9,845
                       24,605   13,380

 

 

11. Other intangible assets

 Cost                                                    Total

                                                         £000s
 At 1 January 2019                                       24,075
 Additions                                               604
 Translation movement                                    (112)
 At 31 December 2019                                     24,567
 Acquisitions through business combinations              8,730
 Additions                                               542
 Translation movement                                    (63)
 At 31 December 2020                                     33,776
 Amortisation
 At 1 January 2019                                       20,335
 Charge for the year                                     1,503
 Impairment charge                                       -
 Translation movement                                    (26)
 At 31 December 2019                                     21,812
 Charge for the year                                     2,266
 Translation movement                                    80
 At 31 December 2020                                     24,158
 Net book value
 At 31 December 2020                                     9,618
 At 31 December 2019                                     2,755

 

 

12. Equity investments

 2020                            Carrying    Equity              Change in fair value recognised  Impairment of  Disposals  Translation  Carrying

amount at
received in

amount at

                   in the income                    investments    £000s      movement

                                 1 January   exchange for

            31 December

                   statement                        £000s                     £000s

                                 2020        services provided
                                                                       2020

                   £000s

                                 £000s       £000s                                                                                       £000s
 Asarina Pharma AB               -           699                 (511)                            -              (175)      (13)         -
 Modus Therapeutics Holdings AB  -           -                   -                                -              -          -            -
                                 -           699                 (511)                            -              (175)      (13)         -

 

 

 2019                            Carrying    Equity              Change in fair value recognised  Impairment of  Disposals  Translation  Carrying

amount at
received in

amount at

                   in the income                    investments    £000s      movement

                                 1 January   exchange for

            31 December

                   statement                        £000s                     £000s

                                 2019        services provided
                                                                       2019

                   £000s

                                 £000s       £000s                                                                                       £000s
 Asarina Pharma AB               863         567                 (286)                            -              (1,099)    (45)         -
 Modus Therapeutics Holdings AB  1,202       1,337               -                                (2,427)        -          (112)        -
                                 2,065       1,904               (286)                            (2,427)        (1,099)    (157)        -

 

Asarina Pharma AB ('Asarina')

In 2018, Asarina completed a public offering and listing on the Nasdaq First
North Exchange and the investment in equity was publicly traded. Under the
co-development agreement with Asarina, the Group receives shares in Asarina in
return for services provided to them under the co-development programme.
During the year ended 31 December 2020, shares valued at £699,000 (2019:
£567,000) were issued to the Group in exchange for services provided. All the
shares received were sold in the year for proceeds of £175,000 (2019:
£1,099,000).

 

Modus Therapeutics Holding AB ('Modus')

Under the co-development agreement with Modus, the Group receives shares in
Modus in return for its contribution to the co‑development programme. During
the year ended 31 December 2019, shares valued at £1,337,000 were issued to
the Group in exchange for services provided by the Group.

Modus announced the initial results from its Phase II trial on 13 May 2019.
Data from the study failed to show a meaningful benefit in the total study
population. Given the results of the trial and the company's lack of funding,
management have impaired the value of the investment to £nil as at the year
end.

 

 

13. Trade and other receivables

                                              2020     2019

                                              £000s    £000s
 Trade receivables                            19,079   11,235
 Amounts receivable from Group companies      -        -
 Other receivables                            1,241    1,609
 Prepayments                                  1,482    1,144
 Corporation tax receivable                   422      371
                                              22,224   14,359

 

 

14. Cash and cash equivalents

Cash and cash equivalents comprise cash balances and short-term deposits.

 

                   2020     2019

                   £000s    £000s
 Cash at bank      18,994   14,259

 

The Group has a £15 million multi-currency rolling credit facility ('RCF')
with an option to increase by a further £15 million. The RCF was drawn down
on 23 March 2020 and was subsequently repaid on 19 August 2020. The RCF
expires on 13 March 2024.

 

 

15. Trade and other payables

                                         2020     2019

                                         £000s    £000s
 Trade payables                          4,197    2,579
 Amounts payable to related parties      55       58
 Amounts payable to Group companies      -        -
 Social security and other taxes         1,112    629
 Other payables                          1,295    1,086
 Customer advances                       408      537
 Accruals                                8,635    5,484
                                         15,702   10,373

 

 

16. Ordinary share capital

                                                 2020                2019
                                                 Number      £000s   Number      £000s
 Ordinary shares of £0.01 each
 Balance at 1 January                            47,286,289  473     45,175,248  452
 Exercise of share options                       1,433,237   14      2,111,041   21
 Shares to be issued for non-cash consideration  155,558     2       -           -
                                                 48,875,084  489     47,286,289  473

 

                                                          2020                    2019
                                                          Number        £000s     Number  £000s
 B Ordinary shares of £0.23 each
 Balance at 1 January                                     -             -         -       -
 Capitalisation of Merger reserve to 'B' Ordinary Shares  48,717,776    11,088    -       -
 Cancellation of 'B' Ordinary Shares                      (48,717,776)  (11,088)  -       -
                                                          -             -         -       -

 

Options over 1,433,237 (2019: 2,111,041) Ordinary Shares were exercised for
proceeds of £1,869,000 (2019: £1,427,000).

 

Shares to be issued for non-cash consideration

Ordinary shares to be issued as consideration for acquisitions (non-cash
consideration) are included within share capital once the conditions for
issuance have been met. Included within the ordinary share capital at 31
December 2020 are 155,558 Ordinary Shares that will be issued as part
consideration for the acquisition of MS Clinical Services, LLC. and its
subsidiaries and is subject to the satisfaction of certain representations and
warranties. The shares will be issued during the 2021 financial year.

 

Capital reduction

During the year the Directors determined that they would request shareholder
and court approval for a capital reduction for Ergomed plc, whereby the
balance on the Company's share premium account and merger reserves would be
used to eliminate the deficit on the retained earnings reserve.

The Capital Reduction was approved by shareholders at a General Meeting of the
Company held on 19 October 2019. The Capital Reduction was sanctioned by the
High Court of England and Wales on 10 November 2020 and was registered with
the Registrar of Companies on 17 November 2020 whereupon it became effective.

The Capital Reduction comprised: (i) the cancellation of the entire amount
standing to the credit of the Company's share premium account and (ii) the
capitalisation of the entire amount standing to the credit of the Company's
merger reserve by issuing B ordinary shares in the capital of the Company and
the subsequent cancellation of such B ordinary shares (the 'Merger Reserve
Reduction').

 

Share premium

As a result of the Capital Reduction, the entire amount standing to the credit
of the Company's Share premium (£27,642,000) was cancelled on 17 November
2020.

 

Merger reserve

When the Company issues shares in consideration for the shares in an acquired
entity, and on completion of the transaction the Company has secured at least
a 90% equity holding in the other entity, the excess of the fair value of the
shares over the nominal value is credited to the merger reserve ('Merger
Relief').

As a result of the Capital Reduction, the entire amount standing to the credit
of the Company's Merger reserve (£11,088,000) was capitalised on 9 November
2020 by issuing 48,717,776 B ordinary shares of £0.227584 each in the capital
of the Company. The B ordinary shares were subsequently cancelled on 17
November 2020.

On 11 December 2020, 155,558 Ordinary Shares were offered as part
consideration for MS Clinical Services LLC, MedSource UK Ltd and MS Clinical
Services (Canada) Inc ('MedSource') at an agreed market price of £8.76 per
share. The excess of the fair value over the nominal value of £1,349,000 was
credited to the merger reserve. The shares are subject to the satisfaction of
certain representations and warranties and will be issued during the 2021
financial year

 

 

17. Acquisition of subsidiary - PrimeVigilance USA Inc.

On 13 January 2020, the Group acquired all the issued share capital in
Ashfield Pharmacovigilance Inc. for $10,000,000, satisfied in cash.
Immediately after acquisition the subsidiary changed its name to
PrimeVigilance USA Inc. The company is a specialist pharmacovigilance provider
based in the US. The acquisition expands the geographical coverage of
PrimeVigilance, the pharmacovigilance brand of the Ergomed group, and further
develop the Group's broader combined CRO and PV business globally.

 

                                                   Book     Fair          Final

                                                   value    value         valuation

                                                   £000s    adjustments   £000s

                                                            £000s
 Intangible assets                                 159      2,392         2,551
 Property, plant and equipment                     779      -             779
 Right-of-use assets                               987      -             987
 Total non-current assets                          1,925    2,392         4,317
 Trade and other receivables                       1,462    (75)          1,387
 Cash and cash equivalents                         727      -             727
 Current assets                                    2,189    (75)          2,114
 Trade and other payables                          (321)    -             (321)
 Lease liability                                   (1,075)  -             (1,075)
 Tax payable                                       -        -             -
 Deferred tax liability                            (1,945)  1,282         (663)
 Financial liabilities                             (3,341)  1,282         (2,059)
 Total identifiable net assets                     773      3,599         4,372
 Goodwill                                          7,703    (3,692)       4,011
 Total consideration                               8,476    (93)          8,383
 Satisfied by:
 Cash                                                                     7,613
 Cash - working capital advance                                           770
 Total consideration                                                      8,383
 Net cash outflow arising on acquisition
 Cash consideration                                                       8,433
 Less: cash and cash equivalent balances acquired                         (727)
 Less: working capital adjustment                                         (93)
 Transaction expenses                                                     407
                                                                          8,020

 

The fair value of intangible assets relates to customer relationships of
£1,998,000 and contracted orderbook of £553,000. The Group incurred
acquisition related cost of £393,000 related to due diligence and legal
activities in the year ended 31 December 2019 and an additional £14,000 in
the year to 31 December 2020. These costs have been included in acquisition
costs within selling and administrative expenses in the Group's consolidated
income statement.

 

The fair value of acquired receivables was £1,250,000. The gross contractual
amount receivable is £1,325,000 and, at the acquisition date, £75,000 of
contractual cash flows were not expected to be received

 

Ergomed plc has a 12-month measurement period from the date of acquisition,
and therefore the measurement period ended on 13 January 2021.

 

 

18. Acquisition of subsidiary - MedSource

On 11 December 2020, the Group acquired all of the issued share capital in MS
Clinical Services, LLC, MedSource UK Ltd and MS Clinical Services (Canada) Inc
('MedSource') for $16,200,000 in cash, adjusted for net debt, and paid at the
closing of the transaction, with further consideration of $1,800,000 payable
in Ergomed plc equity issued at a price based on the average daily closing
price for 30 days preceding the acquisition (155,558 shares at a price of
£8.76) upon the satisfaction of certain representations and warranties. Up to
a further $7,000,000 is payable, 90% in cash and 10% in equity, depending on
MedSource's financial results in the year to 31 December 2021.

MedSource is a full-service CRO with a focus on complex diseases and study
designs. The acquisition greatly expands the geographical presence of
Ergomed's CRO service offering in the US whilst complementing the current
business specialism in oncology and rare disease. Eric Lund, founder of
MedSource and the primary shareholder, will continue in his current role as
President of MedSource after the acquisition.

 

                                                   Book     Fair          Provisional

                                                   value    value         valuation

                                                   £000s    adjustments   £000s

                                                            £000s
 Intangible assets                                 475      5,704         6,179
 Property, plant and equipment                     89       -             89
 Right-of-use assets                               -        131           131
 Total non-current assets                          564      5,835         6,399
 Trade and other receivables                       3,062    -             3,062
 Cash and cash equivalents                         4,346    -             4,346
 Current assets                                    7,408    -             7,408
 Trade and other payables                          (2,348)  -             (2,348)
 Lease liability                                   -        (131)         (131)
 Deferred Revenue                                  (6,528)  -             (6,528)
 Deferred tax liability                            -        (1,607)       (1,607)
 Financial liabilities                             (8,876)  (1,738)       (10,614)
 Total identifiable net assets                     (904)    4,097         3,193
 Goodwill                                          11,347   (4,097)       7,250
 Total consideration                               10,443   -             10,443
 Satisfied by:
 Cash                                                                     9,092
 Equity                                                                   1,351
 Total consideration                                                      10,443
 Net cash outflow arising on acquisition
 Cash consideration                                                       8,764
 Less: cash and cash equivalent balances acquired                         (4,346)
 Add: working capital adjustment                                          328
 Transaction expenses                                                     825
                                                                          5,571

 

The fair value of intangible assets relates to customer relationships of
£4,077,000, contracted orderbook of £1,186,000 and brand of £916,000.

 

The Group incurred acquisition related cost of £825,000 related to due
diligence and legal activities in the year ended 31 December 2020. These costs
have been included in acquisition costs within selling and administrative
expenses in the Group's consolidated income statement.

 

Ergomed plc has a 12-month measurement period from the date of acquisition,
and therefore the measurement period will end on 11 December 2021.

 

 

 

 

 

 

 

 

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