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Focusing on the 
development of  
regenerative products

Annual Report and Financials  
for year ended 31 December 2020

Stock Code: TRX

 
 
 
 
 
 
 
 
 
 
 
 
 
TISSUE REGENIX GROUP 
(“TISSUE REGENIX”) IS 
AN INTERNATIONAL, 
PIONEERING MEDICAL 
TECHNOLOGY COMPANY

Chairman’s statement 

Who we are 

At a glance 

Highlights 

S Overview
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Our markets

Product pipeline

Strategic report

Capacity Expansion Project

Our divisions 

Business model 

Our strategic growth drivers 

Future milestones:  
strategy in action 

Key performance indicators 

Our management team

CEO  
operational review 

Financial overview 

Risks

Sustainability 

s172 statement

02

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03

04

08

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10

12

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16

20

22

24

28

34

38

44

46

Governance

Profile of the current Directors  50

Corporate governance 

52

Directors’ remuneration report  58

Directors’ report 

Statement of Directors’ 
responsibilities 

60

62

Financials

Independent Auditor’s Report 

63

Consolidated statement  
of comprehensive income 

Consolidated statement  
of financial position 

Consolidated statement  
of changes in equity

Consolidated statement  
of cash flows 

Notes to the consolidated 
financial statements 

Company statement  
of changes in equity 

Company statement  
of financial position

Company statement  
of cash flows

Notes to the Company 
financial statements

Notice of Annual General 
Meeting

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TISSUE REGENIX GROUP PLC

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TISSUE REGENIX GROUP

Focusing on the development of regenerative products using our 
two platform technologies, dCELL®, addressing soft tissue needs, 
and BioRinse®, providing sterile bone allografts.

We are currently helping to transform the treatment 
of patients in key surgical applications: BioSurgery, 
Orthopaedics (sports medicine/spine), Dental, General, Plastic 
Surgery, Urology/Gynaecology, Ophthalmology, and Cardiac.

Investment case

Our values 

1 Two novel regenerative 
0

medicine platforms for the 
treatment of soft tissues, 
bone and birth tissues

Dedication to 
patients

2 International 
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manufacturing  
capabilities

3 Expansive distribution 
0

and commercialisation 
opportunities

4 Innovative product  
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portfolio and pipeline

5 Tissue processing  
science and  
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development expertise

6 Differentiated clinical 
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outcomes

Our vision
To establish Tissue Regenix as a global  
leader in the science and innovation of 
regenerative medicine. Transforming  
patient care and delivering favourable  
health economic outcomes.

Passion for 
innovation

Drive for  
excellence

Uncompromising  
integrity

Group snapshot

 ▶ £12.8m revenue FY2020

 ▶ £9.6m cash at 31 December 2020

 ▶ £13.8m (net) equity fundraise, June 2020

 ▶ Capacity expansion programme  

commenced in San Antonio

 ▶ Distribution via strategic partners, direct 
specialist sales and distribution partners

 ▶ Two new product launches undertaken 

during 2020

02

ANNUAL REPOR T AND ACC OUNTS FOR THE YEAR ENDED 31 DEC EMBER 2020

 
 
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Financial
 ▶ Completed an equity fundraise via placement 
of ordinary shares raising net proceeds of 
£13.8m, June 2020

R&D, Clinical 
 ▶ 19 new DermaPure® clinical case studies 

undertaken for new applications 

 ▶ 2 case studies commenced for BioRinse® 

 ▶ Implemented cost reduction initiatives 

orthopaedic applications 

reducing the overhead cost base by £400,000

Revenue growth by product
Annual growth (including impact of FX)

BioRinse®

dCELL®

FY18

FY19

FY20

31% 

79%

5%

25%

11%

(22)%

£12.8m

Group sales decreased 
(2019: £13.0m) -2%, driven by:

 ▶ Orthopaedics and Dental revenue of £7.4m, 

+11% (£2019: £6.7m)

 ▶ Joint venture GBM-v achieved sales of £2.1m 

(2019: £2.1m) 

 ▶ OrthoPure® XT prospective and two-year follow 
up clinical data white papers publicly available 

 ▶ Continuation of OrthoPure® XT clinical data 

collection 

Commercial
 ▶ New strategic collaboration with a top 10 

global healthcare company for white label 
manufacturing

 ▶ EU and UK distribution agreements signed 

for OrthoPure® XT

 ▶ Additional commercial opportunities 

secured for growth product lines such as 
AmnioWorks™, diversifying the sales portfolio 

Management / Governance 
 ▶ Daniel Lee appointed as Chief Executive 

 ▶ DermaPure® sales decreased by 22% to £3.3m 

Officer 

(2019: £4.2m)

£9.6m

Cash balance at 31 December 2020 

(2019: £2.4m)

Operational
Operations

 ▶ Capacity expansion programme commenced 

in San Antonio, July 2020

 ▶ CE Mark approval for OrthoPure® XT,  

June 2020

 ▶ Relocation of UK facility to Garforth, Leeds, 

October 2020

 ▶ Operational improvement initiatives 
implemented at San Antonio facility 

 ▶ Jonathan Glenn appointed interim  

Non-Executive Chairman 

 ▶ Corporate governance review undertaken 

and initiatives being implemented

Post balance sheet events 
 ▶ Trevor Phillips and Brian Phillips  

(no relation) appointed as Independent  
Non-Executive Directors

 ▶ David Cocke appointed Chief Financial 

Officer, January 2021

 ▶ Restructuring of US Operations, estimated 
to save c.$700k on an annualised basis, 
January 2021

 ▶ Occupation of initial phase of the facility 

expansion in San Antonio, Texas, March 2021

 ▶ Jonathan Glenn appointed Non-Executive 

Chairman, February 2021

77
employees

4
Product Line 
Extensions 
in Pipeline

3
Global  
Manufacturing  
Facilities 

7
Countries 
Supplied to 

03

OVERVIEW’

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With the outbreak of the 
COVID-19 pandemic, 2020 
was always going to be a 
challenging year for the Group, 
however, the management 
team dealt with the demands 
admirably and also achieved 
a significant number of 
milestones. The pandemic 
had a significant impact 
on our ability to grow our 
top line revenue due to the 
postponement of many elective 
surgical procedures, and a 
slowdown of product approvals 
in new hospital institutions. 
Despite this, we were successful 
in achieving several commercial 
milestones upon which the 
Company can build its future 
success. 

Financial performance
The Group reported top-line revenue of 
£12.8m (2019: £13.0m) which is down 2% as a 
result of the COVID-19 pandemic. Despite the 
decline in surgeries caused by the pandemic, 
the BioRinse® portfolio returned 11% growth 
driven mainly by increased penetration of the 
AmnioWorks™ product line.

The DermaPure® portfolio was hit more sharply 
by the pandemic, with revenue dropping 22%, 
as the indications, DermaPure® targets were 
more affected by the cessation of elective 
surgeries in the US.

Our controlled joint venture, GBM-v, 
maintained its revenues at 2019 levels despite 
surgical lockdowns in its German cornea 
business.

As part of its COVID-19 response, the US 
subsidiaries applied and received loans under 
the US Government’s PPP program. These 
loans may be converted into grants if used 
for permitted purposes. The Group believes it 
has met these conditions and has accordingly 
classified the proceeds of £815k as Grant 
Income, in addition to £40k received through 
the UK furlough scheme.

Shareholders and Funding
In June 2020, the Group successfully raised 
£13.8m (net) (£14.6m gross) of funding through 
a placement of equity. This, together with a 
restructuring and optimisation of the cost 
base has ensured the Group is in a significantly 
stronger financial position in 2021 and are 
able to continue to weather the impact of the 
enduring COVID-19 pandemic.

Furthermore, this injection of capital has 
allowed for the commencement of the 
capacity expansion programme in San 
Antonio, Texas. Phase 1 of this programme, 
which commenced in July 2020, is expected to 
increase the BioRinse® processing capacity by 
c.50% once operational, alleviating the capacity 
constraints which have historically impinged 
on the growth of the business. 

In order to facilitate this placing, the Group 
attracted a number of new institutional and 
private investors which has significantly 
changed the size and shape of our shareholder 
base. I would like to thank all of our new and 
existing shareholders for their continued 
support. 

Operations and the impact  
of COVID-19
The COVID-19 pandemic and associated 
restrictions provided an unprecedented and 
complex landscape to navigate, however, we 
successfully maintained all operations at the 
San Antonio facility allowing us to continue to 
service customer demand, whilst also building 
inventory to meet the projected demand 
once a normalised level of procedures has 
returned. Outside of this, as mentioned above, 
the commencement of the first phase of the 
capacity expansion project in July 2020 will 
provide additional capacity from H1 2021. 

Throughout the pandemic, the main priority 
of the Board has been the wellbeing and 
safeguarding of our employees, customers, 
suppliers and all other stakeholders. In the UK, 
operations and technical staff were furloughed 
from March in accordance with the UK 
Government advice. However, with the launch 
of OrthoPure® XT scheduled for Q4 2020 all 
staff were re-engaged in July to ensure this 
timeline could be met. 

Outside of this, the Group continued to 
implement several overhead cost reduction 
initiatives and the decision was made to 
relocate the UK head office and manufacturing 
facility to Garforth, Leeds from October 2020 
which is expected to deliver annualised savings 
of £0.4m from 2021. 

More information on our Financial performance 
can be found on pages 34 and 37

More information on our Operations can be 
found on pages 28 to 33

04

TISSUE REGENIX GROUP PLCANNUAL REPORT AND ACCOUNTS FOR THE YEAR ENDED 31 DECEMBER 2020  
OVERVIEW

“

Our 2020 performance was strong 
against the difficult backdrop of 
COVID-19, and the Group achieved 
significant operational and commercial 
progress. Securing the additional funding 
to invest in starting our US facility 
expansion, coupled with significant 
opportunities that lie before us, has the 
potential to change the trajectory of the 
Group. With the introduction of two new 
non-executive directors and Danny and 
David leading the senior management 
team, the Group is in a strong position for 
future success once healthcare systems 
return to a normalised level of operation.”

Jonathan Glenn 
Chairman

05

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Our strategy
Our strategy has evolved with the main 
focus now being the commercialisation 
of our product pipeline. A key factor in the 
success of this is our ability to attract and 
maintain significant strategic partners and 
key customers. During 2020, we successfully 
launched a new product under a white label 
opportunity with a top 10 global healthcare 
company, signed additional customers, 
particularly focusing on our lesser known 
product lines, and expanded into the UK and 
EU markets with the launch of OrthoPure® XT. 

We continue to seek new partnership 
opportunities and have identified additional 
product line extensions and therapeutic 
areas which will drive market adoption and 
penetration, whilst diversifying the Group’s 
sales portfolio and geographic outreach which 
we can pursue once the additional processing 
capacity is fully operational. 

Management
In November 2020, Gareth Jones, interim 
CEO resigned from his position within the 
Company. After reviewing the strategic 
direction of the business and running a formal 
process with an external recruitment firm, the 
Board made the decision to appoint Daniel 
(Danny) Lee as CEO of the Group. Danny, who 
has over 30 years of industry experience, joined 
as President of US Operations in January 
2019 and has been responsible for leading 
the capacity expansion and optimisation 
programme in San Antonio. 

Following the year end, in January 2021, David 
Cocke was appointed as CFO for the Group and 
is based alongside Danny in San Antonio. David 
has 30 years experience in senior finance and 
operations roles having previously been CFO 

at Aperion Biologics, Inc. and founding NuPak 
Medical in 1997 which was later acquired by 
Katena Products, Inc in 2017.

I would like to take this opportunity to 
welcome both Danny and David to the 
Group and on behalf of the Board, I would 
like to thank Gareth for his commitment and 
leadership throughout what was a particularly 
challenging year for business. 

The Board
The Board of Directors underwent a number of 
other changes during 2020 in order to ensure 
that its size, composition and skill set remained 
relevant to the requirements and strategy of 
the Group. After significant tenures on the 
Board, both Alan Miller and Randeep Grewal 
resigned their positions as Non-Executive 
Directors, following which Trevor Phillips and 
Brian Phillips (no relation) were appointed. 
Brian and Trevor bring a wealth of experience 
particularly regarding operations and 
corporate development in the lifescience 
industry and financial management, which will 
be key in driving the Company’s future success.

In March 2020, John Samuel, former Executive 
Chairman, also resigned from the Board and 
I stepped up to fill the Chairman’s role on an 
interim basis and latterly on a permanent 
basis. With the appointment of Danny Lee as 
permanent CEO, David Cocke as CFO and two 
new Non-Executive Directors, Tissue Regenix 
has a strong new team to lead the Group 
forward. 

Our employees
Our skilled employees are a key stakeholder 
in the success of the Group and I would like to 
thank them for their ongoing hard work and 
commitment. 2020 has been an uncertain 

06

TISSUE REGENIX GROUP PLCANNUAL REPORT AND ACCOUNTS FOR THE YEAR ENDED 31 DECEMBER 2020  
Outlook
During 2020, the Group achieved a number 
of significant milestones and we remain 
focused and committed to creating long-
term, sustainable value for our shareholders 
by increasing our market penetration through 
leveraging relationships with strategic 
partners, and improving our portfolio offering 
with product line extensions for identified, 
underserved clinical applications.

The capacity expansion programme will 
alleviate the supply issues that have previously 
hindered the growth of the Group and 
moving forward will provide a step-change 
in the trajectory of the business as we secure 
additional distribution contracts and have the 
ability to increase our geographic outreach. 

Having successfully entered the UK and 
specific EU markets with OrthoPure® XT, and 
establishing our white label manufacturing 
capabilities with a large global partner, the 
Board has confidence in the prospects of 
the Group once the COVID-19 pandemic has 
subsided and healthcare procedures return to 
a normalised level.

Jonathan Glenn 
Chairman

27 April 2021

year, particularly for the UK employees who 
were furloughed for a period of time due to 
the pandemic, but through their continued 
commitment and focus on maintaining a 
COVID-19 free work environment, the Group 
has emerged in a stronger position to execute 
our strategic growth drivers, increasing our 
market penetration and moving closer to 
profitability.

Post balance sheet events
As we transitioned into 2021, COVID-19 
continued to impact the return of elective 
surgeries. The Group continued to service its 
customers and partners and positioned the 
business to be ready for a resumption of the 
growth it experienced prior to the COVID-19 
outbreak.

The expansion plans for the San Antonio 
facility continued and the initial phase was 
successfully completed and occupied in March 
2021. The expansion enabled the company to 
transfer its distribution and freezer facilities to 
the new building which provides the additional 
capacity for donor tissue, the foundation 
for growth. The new facility provides a more 
centralised and efficient arrangement for 
product distribution needs in the short 
and long term. In our existing building, the 
relocation of the freezer facility now enables us 
to expand our clean rooms which will provide 
additional processing capacity during H1 
2021. The relocation of distribution to the new 
building, provides the departments remaining 
in our existing facility the ability to increase 
their capacity and throughput, as well as the 
space for future needs.

07

OVERVIEWTISSUE REGENIX GROUP PLC

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areas. Four strategic growth drivers.

E Two innovative technology platforms. Multiple clinical application  
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Through our platform technologies, Tissue Regenix is focused 
on the commercialisation of regenerative medicine products, 
helping to transform the treatment of patients in key surgical 
applications:

BioSurgery, Orthopaedics (sports medicine/spine), Dental, 
General, Plastic Surgery, Urology/Gynaecology, Ophthalmology 
and Cardiac.

Innovative platform technologies
Addressing clinical needs through complementary bone and soft tissue platforms

Gentle soft tissue decellularisation process, 
removes DNA and cellular material to reduce 
risk of rejection 

Natural bone void filling solutions verified to 
be osteoinductive to stimulate and regenerate 
native bone 

Differentiated characteristics: 
 ▶ Maintains the natural scaffold structure 
of the tissue and provides an acellular 
structure to allow for cellular proliferation 

Differentiated characteristics: 
 ▶ Maintaining the key natural bone growth 

factors and bone morphogenic proteins that 
promote active regeneration 

 ▶ Supports regeneration of native tissue 

 ▶ Contains 100% allograft bone, proven to 

 ▶ Stored at room temperature

 ▶ Can be applied to both human or animal 

tissue sources

 ▶ Favourable health economic benefits due 
to reduced operation time, reduction in 
rehabilitation required, no anticoagulant 
drugs 

produce better clinical outcomes 

 ▶ Every lot verified to be osteoinductive post 

sterilization

 ▶ Ability to deliver biological scaffolds in 

various physical forms to meet clinical needs

Product portfolio
High growth product lines focused on bone, skin (dermis) and birth tissue:

Bone
BioRinse®

Soft Tissue
dCELL®

Birth Tissue
Proprietary

Flagship Products
ConCelltrate®

Applications 
 ▶ Spine

 ▶ Foot/ankle

 ▶ Dental

Flagship Products
DermaPure®

Applications 
 ▶ Urogynaecology

 ▶ Sports medicine

 ▶ Open wound

 ▶ Orthopaedics

 ▶ Plastics

Flagship Products
AmnioWorks™

Applications 
 ▶ Ophthalmology

 ▶ Wound covering

Differentiators 
 ▶ Induces new bone growth

Differentiators 
 ▶ Clinical outcomes

Differentiators 
 ▶ Clinical outcomes

 ▶ Faster healing

 ▶ No second graft site required

 ▶ Barrier can provide faster 

 ▶ Superior handling

 ▶ Stored at room temperature

 ▶ Reduced flush out

 ▶ Superior handling

healing

 ▶ Stored at room 
temperature

08

ANNUAL REPOR T AND ACC OUNTS FOR THE YEAR ENDED 31 DEC EMBER 2020

 
  
 
 
 
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of clinical indications. 

E The Group has a novel product portfolio to address a number  
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DermaPure® Non-Oriented – 
Decellularised allograft dermal tissue 
with no basement membrane 

DermaPure® – Decellularised allograft 
dermal tissue 

Orthopaedics, trauma, wound care

Urogynaecology, general surgery

Application/indication

Classification 

Product

HCT/Ps

HCT/Ps

I

Primary 
market 

USA 

USA

SurgiPure XD – Decellularised 
xenograft dermal tissue 

OrthoPure® XT – Decellularised 
xenograft tendon

ConCelltrate 100 – Demineralised 
allograft bone matrix 

Matrix OI FlexIt – Demineralised 
cortical bone strip 

Matrix OI 100 DBM – Demineralised 
cortical fibres and fillers with 
mineralised cancellous fibres

Matrix OI Strips & Blocks –  
Cell containment scaffold that 
minimises and compliments the use 
of fixation devices

MatrixCellect 100 DBM – 
Demineralised allograft  
bone putty 

MatrixCellect 100 DBM  
Crunch – Demineralised  
allograft bone matrix  
containing cancellous chips 

Hernia repair

Revision, multiligament ligament  
reconstruction, including primary 
reconstruction when autograft is unavailable

510(k) device 
clearance, Class II

USA 

Class III device, 
CE Mark received

UK and 
EU

Orthopaedics, spine 

HCT/Ps 

Maxillofacial, periodontal defects 

HCT/Ps

Spine, non-structural bone-grafting 

HCT/Ps

USA

USA

USA 

Orthopaedics, spine

HCT/Ps

USA

Orthopaedics, trauma, spine 

HCT/Ps

USA

Orthopaedics, trauma, spine 

HCT/Ps

USA 

Matrix IQ – Decellularised allograft 
dermal tissue 

Dental and maxillofacial 

AmnioWorks™ –  
Allograft Amniotic membrane 

DentalFix – mineralised particulate 
allografts featuring  
a unique elongated shape

Ophthalmology, wound care 

Dental and maxillofacial 

Key: 

Tissue types:

Allograft – donated human 
tissues/bone 

Xenograft – donated porcine 
(pig) tissue 

Amniotic membrane – inner 
most layer of the placenta 
recovered following delivery of 
the child 

Demineralised Cortical bone – 
the dense part of the bone, 
which has been processed 
to retain biologic properties 
including growth factors 

Demineralised Cancellous 
bone – porous bone matrix 
which retains biologic 
properties and provides a 
scaffold to allow growth of the 
patient’s own bone

Classification: 

HCT/Ps – USA classification 

Human cells and tissue-based 
products (HCT/Ps) consisting 
of human cells or tissues 
intended for implantation, 
transplantation, infusion 
or transfer into a human 
recipient.1 Products must be: 

 ▶ Minimally manipulated 

 ▶ Intended for homologous 

use only 

510(k) clearance –  
USA regulatory pathway 

A 510(k) is a premarket 
submission made to FDA to 
demonstrate that the device 
to be marketed is as safe and 
effective, that is, substantially 
equivalent, to a legally 
marketed device.2

HCT/Ps

HCT/Ps

HCT/Ps

USA

USA

USA

CE Mark approval – UK & EU 
regulatory pathway 

Demonstrate that the 
medical device meets the 
requirements in the Medical 
Devices Directive (MDD) or the 
more recent Medical Device 
Regulation (MDR) by carrying 
out a conformity assessment. 
The assessment route depends 
on the classification of the 
device. The CE mark can be 
placed on the product to show 
that the medical device has 
met the requirements when 
it has passed the conformity 
assessment.3

1.  http://www.aabb.org/advocacy/

regulatorygovernment/ct/hctps/
Pages/default.aspx

2.  https://www.fda.gov/medical-devices/

premarket-submissions/premarket-
notification-510k 

3.  https://www.gov.uk/guidance/medical-

devices-conformity-assessment-and-
the-ce-mark

09

OVERVIEW  
TISSUE REGENIX GROUP PLC

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Securing the additional funding in June 2020 allowed the 
Group to commence a capacity expansion programme at the 
facility in San Antonio in July 2020. 

The project is to be split in phases to allow 
for the efficient deployment of capital, as 
well as ensuring to bring capacity online in a 
controlled and managed process. 

Phase 2 of the expansion project will entail up 
to a further potential ten clean rooms in the 
new facility, which would take approximately 
12 months to build. Due to the deferment of 
surgical procedures as a result of COVID-19 and 
the production improvements in the existing 
facility, along with the increased capacity 
offered by phase 1, commencement of phase 
2 has been put under review by the Board to 
ensure that the market demand has recovered 
sufficiently before the investment 
is made. 

Phase 1 commenced in July 2020 and involved 
moving freezer space and distribution 
functions into the new facility, allowing two 
additional sterile packaging clean rooms to be 
Capacity Expansion Project  
installed in the existing facility and increasing 
the BioRinse® processing capacity by c.50%. 
Securing the additional funding in June 2020 allowed the Group to commence a capacity expansion programme at the facility in San Antonio in July 2020.   
This was completed in March 2021 however, 
due to the significant lead time required for 
The project is be split in phases to allow for the efficient deployment of capital, as well as ensuring to bring capacity on-line in a controlled and managed process.   
the osteoinductive testing of our BioRinse® 
Phase one commenced in July 2020 and will involve the moving of freezer space and distribution functions into the new facility, which will in turn allow two additional sterile packaging 
portfolio, the first products processed from 
clean rooms to be installed in the existing facility, increasing the BioRinse processing capacity by c.50%.  This was completed during Q1 2021 however, due to the significant lead time 
phase one of the expansion are expected to be 
required for the osteoinductive testing of our BioRinse portfolio, the first products processed from phase one of the expansion are expected to be available during Q2 2021. 
available during Q3 2021.

Phase 2 of the expansion project will entail a further potential ten clean rooms in the new facility, which would take approximately 12 months to build.  Due to the deferment of surgical 

procedures due to COVID-19 and the production improvements in the existing facility, along with the increased capacity offered by phase one, commencement of phase two has been 

put under review by the Board to ensure that the market demand has recovered sufficiently before the investment is made.  
Phase 1 in new facility

Phase 1  

Phase 1 in new facility 

Phase 1 in Existing Facility

10

ANNUAL REPOR T AND ACC OUNTS FOR THE YEAR ENDED 31 DEC EMBER 2020

Two-room expansion in existing facility 

Global operations infrastructure 
Platform for international expansion 

CellRight Technologies  

San Antonio, Texas 

−  Human Tissue US 

−  Processing dCELL® and BioRinse products 

Tissue Regenix  

Leeds, UK  

−  Porcine Tissue 

−  Processing of OrthoPure XT 

GBM-v Rostock 

Germany  

−  Human Tissue EU 

−  Corneas and working on regulatory approvals for Cardiac products 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
San Antonio, Texas
 ▶ Human Tissue US

 ▶ Processing dCELL® and BioRinse® products

Tissue Regenix Leeds, UK 
 ▶ Porcine Tissue

 ▶ Processing of OrthoPure® XT

GBM-v Rostock Germany 
 ▶ Human Tissue EU

 ▶ Corneas and working on regulatory  

approvals for Cardiac products

STRATEGIC REPOR T

11

R
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S Regenerative medicine
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Regenerative medicine is an interdisciplinary 
field that seeks to develop the science and 
tools that can help repair or replace damaged 
or diseased human cells or tissues to restore 
normal function, and holds the promise of 
revolutionising treatment in the 21st century.1 
The demand for regenerative solutions is 
driven by demographic shifts both in terms 
of lifestyle-related illness such as obesity and 
diabetes, for example, it is projected that by 
2045 the United State will have 30.4m people 
with diabetes;2 and also the expectation to 
maintain one’s quality of life.

Health economics
The expectation amongst patients to maintain 
levels of mobility and health for much longer 
is driving the emergence of new novel 
technologies that can remove the need for 
repeated or ongoing surgeries and medical 
care, ultimately reducing the overall cost of 
this treatment cycle. Although there is a wide 
acceptance of the value of human tissue 
products in areas such as organ donation, and 
minimally manipulated human tissues, there 
are still many insurance companies that will 
not yet sanction coverage of the more novel 
therapies, which can lead to expensive and 
lengthy clinical trials, particularly for xenograft 
(porcine) tissues. 

The impact of COVID-19 
COVID-19 has had a significant impact on the 
healthcare markets. In the US, following the 
Centers for Medicare and Medicaid Services 
(CMS) releasing guidelines recommending 
postponing or cancelling elective, non-
essential medical, surgical, and dental 
procedures to preserve resources for treating 
COVID-19 patients, it is predicted that hospitals 
in the US lost between 30-55% of their elective 
patients between March and April3, a figure 
that likely increased during the second and 
more aggressive wave of the pandemic that 
hit the US in the fall and winter. Although 
it is expected that once a vaccine has been 
significantly rolled-out, elective surgeries will 
return to pre-pandemic levels, the question 
remains however, at what pace.

Market opportunities
The Global Regenerative medicine market 
is projected to reach $151,949m by 2026 
demonstrating a CAGR of 26.1% during 
2019-2026,4 addressing a growing number of 
clinical needs and Tissue Regenix is helping 
to transform the treatment of patients in key 
surgical applications: BioSurgery, Orthopaedics 
(sports medicine/spine, Dental, General, Plastic 
Surgery, Urology, Gynaecology, Ophthalmology 
and Cardiac.

Our products address sports medicine, spine, 
degenerative diseases, traumatic, surgical and 
oral conditions. The Group is now focused on 
commercialisation of its existing product lines 
and also the launch of product line extensions 
for specific applications where a growing 
clinical demand is seen. 

During 2020, the Group launched a new soft 
tissue orthopaedic product under a white 
label distribution agreement in the US with a 
major strategic partner, and OrthoPure® XT, 
a decellularised porcine tendon for the 
reconstruction of knee ligaments in the EU. 
The first market targeted was the UK where 
the addressable market is expected to be 
£27m. 

Regulatory environment 
The medical device and biologics industry is 
highly regulated with specific country and 
institutional regulations for the approval and 
use of products. Our human tissue products 
are regulated under the 361 HCT/P pathway for 
minimally manipulated tissues in the US, whilst 
in Europe where we look to commercialise 
our xenograft tissues, we are subject to the 
Medicines and Healthcare products Regulatory 
Agency (MHRA), and also, the Medical Device 
Regulations, introduced in 2017. The Group has 
worked closely with notified and regulatory 
bodies to ensure that all required certification 
is in place to retain CE mark certification and 
allow the exportation of products, following the 
exit of the UK from the European Union. 

1.  https://mrc.ukri.org/research/initiatives/regenerative-medicine/ 

2.  https://www2.deloitte.com /fr/fr/pages/covid-insights/articles/impact-covid19-healthcare-systems.html 

3. 

“How The COVID-19 Pandemic Has Affected Provision Of Elective Services: The Challenges Ahead, “ Health Affairs Blog, 
October 8, 2020.DOI: 10.1377/hblog20201006.263687 

4.  https://www.fortunebusinessinsights.com/industry-reports/regenerative-medicine-market-100970

12

TISSUE REGENIX GROUP PLCANNUAL REPORT AND ACCOUNTS FOR THE YEAR ENDED 31 DECEMBER 2020  
R
U
O

I

S The Group comprises of three key commercial divisions allowing each to 
function independently and pursue the appropriate commercial strategy, 
N
access to relevant Key Opinion Leaders and experienced management 
O
teams. This also allows for the benefits of operational synergies across  
the Group whilst reporting against each division individually. 
S
V
D

Due to the COVID-19 pandemic, some 2020 commercial milestones have 
rolled forward into 2021. 

I

I

BioSurgery 

GBM-v & Cardiac 

Multi-tissue bank facility, 
supplying corneas and the 
development of  
human tissue

2020 achievements 

 ▶ Restructured Cardiac 
division to recognise 
significant overhead cost 
reductions 

2021 milestones

 ▶ Further expansion into 
the German cornea 
replacement market

 ▶ Consider complementary 

product lines for 
ophthalmic indications

Repair and replacement of  
soft tissue – dCELL®

2020 achievements

 ▶ Full roll out of DermaPure® 

non-oriented 

 ▶ 19 new clinical case studies

 ▶ Gained approval in five new 

large hospital systems 

2021 milestones

 ▶ Further expansion into the 
North American markets 

 ▶ Secure a strategic partner 
for wound care and other 
applications 

 ▶ Launch product line 

extension specifically 
for urogynaecology 
applications 

 ▶ Launch product line 

extension for wound care / 
dermis applications

STRATEGIC REPOR T

Orthopaedics  
& Dental
Repair and augmentation 
of bone and soft tissue – 
BioRinse® & dCELL®

2020 achievements

 ▶ Continued to develop 

efficiencies to increase 
capacity in existing facility 
which resulted in a c.36% 
increase in processing of 
musculoskeletal tissue 

 ▶ Secured additional strategic 
partnerships for both US 
and overseas opportunities

 ▶ Entered a white label 

distribution agreement 
with top 10 global 
healthcare company for 
new soft tissue orthopaedic 
product

 ▶ Commenced phase one 
of the facility expansion 
project

 ▶ Received CE Mark approval 

for OrthoPure® XT

 ▶ Entered UK and European 

distribution agreements for 
OrthoPure® XT 

2021 milestones

 ▶ Further expand European 
rollout of OrthoPure® XT 

 ▶ Bring online phase one 
of capacity expansion 
programme 

 ▶ Work with current strategic 

partners to expand 
distribution of current 
product portfolio and 
identify and launch new 
product line extensions 

 ▶ Secure additional material 
strategic partnerships 

13

  
TISSUE REGENIX GROUP PLC

L
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S
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I

We aim to implement a business model that ensures our product 
portfolios have the market reach and penetration to deliver novel, 
regenerative solutions to patients, and provide returns to our 
shareholders. Through a combination of strategic partnerships, 
distributors and direct sales, we believe we have a balanced and 
robust business model to drive our commercial growth, achieve 
our key performance indicators and transform patient care.

Our key resources

 Our offering

People
Our employees are key 
to our continued growth 
due to their experience, 
qualifications and 
commitment.

IP

Provides protection for the 
technologies at the heart of 
our business; a fundamental 
resource for our growth.

Working capital 
Supports the product 
development pipeline 
and enables us to make 
investments that support 
our future growth.

Manufacturing capabilities
Fundamental in ensuring 
the production and 
development of our 
products on a global scale.

Strategic partnerships
Allowing faster market 
penetration, physician 
conversion and delivering 
revenue growth.

Licensing and  
distribution agreements
Ensuring we can expand our 
reach and serve the global 
market potential.

BioRinse® Technology
Natural bone filler solutions tested 
for osteoinductivity to stimulate and 
regenerate native bone growth.

This process has the potential to provide 
superior clinical outcomes as it contains 100% 
allograft bone, demonstrating the presence 
of the key natural bone growth factors, and in 
a natural carrier available in various physical 
forms.

dCELL® Technology
Gentle soft tissue decellularisation 
process, removing DNA and cellular 
material to encourage integration 
and minimise the risk of rejection.

The dCELL® process involves the creation 
of biological scaffolds, which are essentially 
inert. By removing DNA and cellular material 
from biological tissues, the patient’s cells 
can repopulate and colonise, creating new, 
like-for-like tissue, which is recognised and 
accepted by the body, significantly reducing 
the risk of rejection, and stimulating a natural 
healing process.

In order to continue to 
create value for our 
stakeholders, we invest in 
the Group’s key resources. 
For example, improving our 
manufacturing capabilities.

14

ANNUAL REPOR T AND ACC OUNTS FOR THE YEAR ENDED 31 DEC EMBER 2020

  
Our key activities

Our competitive advantages

We create value for our 
stakeholders

1
0

Commercialisation
Currently we have a 
portfolio of 14 primary 
product lines on the 
market (excluding white 
label), with new product 
line extensions in the 
pipeline. It is also our 
intention to expand into 
new geographic territories.

2
0

Optimisation
Ensuring that we maintain 
product differentiation, 
optimise our margins and 
have a competitive market 
offering.

3
0

Distribution and licensing
Building a network of key 
strategic partners and 
distributors and evaluating 
licensing opportunities 
for new products and 
geographic territories.

Distributor network
We can leverage 
cross-selling 
opportunities 
through our 
distributor network 
and industry 
relationships.

Team
Our experienced 
management team, 
well qualified and 
skilled employees, 
and knowledgeable 
Board ensure we 
have the capabilities 
to deliver future 
growth.

Innovation
We have an 
innovative product 
pipeline with multiple 
opportunities 
to develop the 
commercialisation 
of our platform 
technologies.

Products
Performance of 
our products in the 
clinical environment 
provides us with 
a competitive 
advantage over 
competitors.

Manufacturing
We have international 
manufacturing 
capabilities and 
an expanding 
geographic presence.

Patients
Providing a return to a better 
quality of life, differentiated 
clinical outcomes and optimised 
healthcare costs.

Partners
Strong strategic partnerships 
with large scale businesses and 
continued growth opportunities 
in the long term.

Physicians and healthcare 
providers
Products with ease of use that 
will benefit their patients and 
provide economic benefits to the 
whole healthcare system.

Shareholders
Investment in a Company with 
growth opportunities that is 
focused on creating sustainable 
value for both shareholders and 
addressing wider socio-economic 
issues.

Employees
We provide training and 
development opportunities, 
promote a positive professional 
culture, and support a healthy 
work/life balance.

 Read more about Sustainability 
on pages 44 to 45

15

STRATEGIC REPORTStrategic objective Description

2020 performance

Focus and goals for 2021+

Link to KPIs

Link to risks

Commentary

Accelerate 
US market 
penetration

The US is the largest 
healthcare market in 
the world and where 
we see the greatest 
opportunity. 

We intend to 
leverage our platform 
technologies dCELL® 
and BioRinse® to 
further our market 
penetration through a 
hybrid sales model, a 
combination of direct 
sales, distribution and 
OEM agreements.

Our current 
commercialisation 
efforts are focused 
on the US markets; 
however, there is 
the opportunity and 
market demand 
for us to enter new 
geographic territories.

Exploit global 
market potential

 ▶ Commenced 
phase one of 
capacity expansion 
programme 

 ▶ Bring onstream 
phase one of 
capacity expansion 
programme 

 ▶ Group sales growth 

 ▶ Finance – Insufficient 

Although COVID-19 may 

 ▶ Increase number of 

strategic partnership and 

funds to invest in the 

required expansion 

have slowed the commercial 

expansion of the Company 

distribution opportunities

 ▶ Operational – The Group 

 ▶ Launch new 
product line 
extensions and 
SKUs

 ▶ Assess the 

commencement 
of phase two of 
capacity expansion 
programme 

 ▶ Increase collection 

of real world clinical 
data highlighting 
our product 
differentiators 

 ▶ Entered white 

label distribution 
agreement

 ▶ Strengthened 

relationships with 
strategic partners 

 ▶ Extended roll out of 
DermaPure® non-
oriented product

 ▶ Expanded 

distribution 
network 

 ▶ With the increased 

supply chain 
and production 
capabilities, 
expanded 
distribution of 
amniotic products 
to further diversify 
product mix

 ▶ Commenced 

phase one of the 
capacity expansion 
programme

 ▶ Bring onstream 
phase one of 
capacity expansion 
programme 

 ▶ Entered into UK 

 ▶ Secure additional 

and EU distribution 
agreements for 
OrthoPure® XT 

 ▶ Expanded network 

of distributors 
outside of the main 
US market

 ▶ Identified 

potential licensing 
opportunities in 
other geographic 
areas 

distribution 
partners for 
the roll out of 
OrthoPure® XT

 ▶ Ramp up market 
awareness of 
BioRinse® products 
outside of US 
market

 ▶ Enter distribution 

arrangements with 
overseas partners 
for the supply of 
our dCELL® product 
range 

 ▶ Continue to pursue 
potential licensing 
opportunities in 
other geographic 
territories

is unable to expand in line 

with demand 

 ▶ Clinical and Regulatory 

– Changes in regulatory 

pathways for products

the injection of Capital 

from the equity fundraise 

in June has allowed us 

to commence the facility 

expansion programme in 

San Antonio and will provide 

sufficient working capital to 

support Company growth 

and drive towards profitability. 

Therefore, although we do 

not consider cash resources 

a major risk, should the 

pandemic continue this could 

become a more pressing 

concern. During 2021, we 

will focus on exploiting 

the milestones achieved in 

2020 and pursuing further 

opportunities with product 

line extensions and additional 

capacity.

the Group’s ability to produce 

sufficient product to service 

demand outside of the core 

US markets. However, with 

the capacity constraints being 

alleviated by the capacity 

expansion programme, we 

envisage that the Group will 

be able to expand its outreach 

into additional geographic 

territories during 2021 and 

beyond. 

 ▶ Group sales growth 

 ▶ Operational – The Group 

Historically, capacity 

is unable to expand in line 

constraints have impacted 

 ▶ Increase number of 

strategic partnerships and 

with demand

distribution opportunities 

 ▶ Clinical and Regulatory – 

Loss of license or 

restriction due to 

regulatory failings

 ▶ Significant change in 

political or economic 

landscape

I

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16

TISSUE REGENIX GROUP PLCANNUAL REPORT AND ACCOUNTS FOR THE YEAR ENDED 31 DECEMBER 2020 
  
 
 
Strategic objective Description

2020 performance

Focus and goals for 2021+

Link to KPIs

Link to risks

Commentary

The US is the largest 

 ▶ Commenced 

 ▶ Bring onstream 

healthcare market in 

the world and where 

we see the greatest 

phase one of 

phase one of 

capacity expansion 

capacity expansion 

programme 

programme 

Accelerate 

US market 

penetration

opportunity. 

We intend to 

leverage our platform 

technologies dCELL® 

 ▶ Strengthened 

label distribution 

agreement

 ▶ Entered white 

 ▶ Launch new 

relationships with 

 ▶ Assess the 

 ▶ Group sales growth 

 ▶ Increase number of 

strategic partnership and 
distribution opportunities

 ▶ Finance – Insufficient 
funds to invest in the 
required expansion 

 ▶ Operational – The Group 

is unable to expand in line 
with demand 

 ▶ Clinical and Regulatory 
– Changes in regulatory 
pathways for products

Exploit global 

market potential

Our current 

commercialisation 

efforts are focused 

on the US markets; 

however, there is 

the opportunity and 

market demand 

for us to enter new 

geographic territories.

 ▶ Commenced 

 ▶ Bring onstream 

phase one of the 

phase one of 

capacity expansion 

capacity expansion 

programme

programme 

 ▶ Entered into UK 

 ▶ Secure additional 

and EU distribution 

agreements for 

OrthoPure® XT 

 ▶ Expanded network 

distribution 

partners for 

the roll out of 

OrthoPure® XT

of distributors 

 ▶ Ramp up market 

outside of the main 

awareness of 

 ▶ Group sales growth 

 ▶ Operational – The Group 

 ▶ Increase number of 

strategic partnerships and 
distribution opportunities 

is unable to expand in line 
with demand

 ▶ Clinical and Regulatory – 

Loss of license or 
restriction due to 
regulatory failings

 ▶ Significant change in 
political or economic 
landscape

product line 

extensions and 

SKUs

commencement 

of phase two of 

capacity expansion 

programme 

 ▶ Increase collection 

of real world clinical 

data highlighting 

our product 

differentiators 

and BioRinse® to 

further our market 

penetration through a 

hybrid sales model, a 

combination of direct 

sales, distribution and 

OEM agreements.

strategic partners 

 ▶ Extended roll out of 

DermaPure® non-

oriented product

 ▶ Expanded 

distribution 

network 

 ▶ With the increased 

supply chain 

and production 

capabilities, 

expanded 

distribution of 

amniotic products 

to further diversify 

product mix

US market

 ▶ Identified 

potential licensing 

opportunities in 

other geographic 

areas 

BioRinse® products 

outside of US 

market

 ▶ Enter distribution 

arrangements with 

overseas partners 

for the supply of 

our dCELL® product 

range 

 ▶ Continue to pursue 

potential licensing 

opportunities in 

other geographic 

territories

Although COVID-19 may 
have slowed the commercial 
expansion of the Company 
the injection of Capital 
from the equity fundraise 
in June has allowed us 
to commence the facility 
expansion programme in 
San Antonio and will provide 
sufficient working capital to 
support Company growth 
and drive towards profitability. 
Therefore, although we do 
not consider cash resources 
a major risk, should the 
pandemic continue this could 
become a more pressing 
concern. During 2021, we 
will focus on exploiting 
the milestones achieved in 
2020 and pursuing further 
opportunities with product 
line extensions and additional 
capacity.

Historically, capacity 
constraints have impacted 
the Group’s ability to produce 
sufficient product to service 
demand outside of the core 
US markets. However, with 
the capacity constraints being 
alleviated by the capacity 
expansion programme, we 
envisage that the Group will 
be able to expand its outreach 
into additional geographic 
territories during 2021 and 
beyond. 

Read more about 
our KPIs on pages 
22 and 23

Read more about 
our Risks on pages 
38 and 43

17

STRATEGIC REPORT 
Strategic objective Description

2020 performance

Focus and goals for 2021+

Link to KPIs

Link to risks

Commentary

Broaden 
strategic 
partnerships

Strengthen 
portfolio

 ▶ Ramp up market 

penetration 
of our smaller 
product lines in 
collaboration with 
strategic partners 

 ▶ Launch new 
product 
developments with 
strategic partners 

 ▶ Enter new clinical 

applications 
and geographic 
territories with 
new and existing 
strategic partners 

 ▶ Entered white label 
manufacturing 
agreement for new 
product with top 10 
global healthcare 
company

 ▶ Secured additional 

strategic and 
distribution 
partners for 
existing product 
portfolio 

 ▶ Launched 

OrthoPure® XT 
into the European 
market securing 
distribution 
partners in the 
UK, Poland and 
Portugal 

 ▶ Expand 

opportunities for 
OrthoPure® XT in 
the UK and select 
European markets

 ▶ Launch new 
product 
developments with 
strategic partners, 
specifically for 
urogynaecology 
and wound care 
applications 

 ▶ Commence post 

marketing clinical 
studies 

 ▶ Launched new 
product in 
collaboration 
with top 10 
global healthcare 
company 

 ▶ Received CE 

Mark approval for 
OrthoPure® XT 
to commence 
European roll out 

 ▶ Collated two year 
clinical data for 
OrthoPure® XT, now 
publicly available 

 ▶ 19 new DermaPure® 
clinical case studies 

 ▶ Two new BioRinse® 
clinical case studies 

Our commercial 
strategy focuses on 
establishing and 
building strategic 
partnerships to 
further our market 
penetration. 

This allows for the 
potential to increase 
OEM agreements and 
initiate discussions 
around joint IP 
collaborations, as 
well as extending 
our geographic 
reach. Key to this, is 
also increasing our 
real world clinical 
data collection to 
highlight our clinical 
differentiators 
for customers, 
reimbursement 
agencies, and 
strategic partners. 

Our success is reliant 
upon the ability to 
commercialise our 
current product 
portfolio and 
the potential for 
augmenting this 
with product line 
extensions and new 
innovative products. 

We look to establish 
a database of 
compelling clinical 
data to validate our 
technology platforms 
and further our 
physician conversion 
rates. 

These clinical data 
portfolios are also 
imperative when 
we seek new 
strategic partnership 
opportunities 
for negotiating 
favourable 
reimbursement 
pricing and when 
navigating regulatory 
clearance in new 
territories.

 ▶ Group sales growth 

 ▶ Operational - The Group 

Despite the challenges 

 ▶ Clinical data collection

is unable to expand in line 

that COVID-19 presented to 

with demand

 ▶ Commercial - Competitor 

product could reach the 

market first, offer pricing 

advantages or outperform 

the Group’s products

 ▶ Clinical – Risk of loss of 

license or restrictions 

the commercial landscape 

during 2020, the Group was 

successful in broadening our 

base of strategic partnerships 

and OEM agreements, and 

remains well positioned to 

build on these relationships 

moving forward. 

 ▶ Clinical data collection 

 ▶ Clinical and Regulatory – 

During 2020, we brought to 

 ▶ Improve breath of product 

portfolio and pipeline 

 ▶ IP collaboration 

Loss of license or 

restriction due to 

regulatory failings

 ▶ Commercial – Competitor 

product could reach the 

market first or outperform 

the Group’s products 

market two new products 

that diversify our product 

portfolio and also provide 

additional opportunities 

with new strategic partners 

and expand our geographic 

footprint. 

 ▶ Finance – Insufficient 

During 2021, we intend 

funds to commence or 

to expand the market 

complete trials 

 ▶ Operational – The Group 

is unable to expand in line 

with demand

 ▶ Clinical and Regulatory – 

Changes to the regulatory 

landscape for our products 

penetration and opportunities 

for these products as well as 

develop further product line 

extensions to address specific 

clinical applications where 

we see a market opportunity 

and have the capabilities to 

execute quickly. 

D
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S
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I

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18

TISSUE REGENIX GROUP PLCANNUAL REPORT AND ACCOUNTS FOR THE YEAR ENDED 31 DECEMBER 2020 
  
 
Strategic objective Description

2020 performance

Focus and goals for 2021+

Link to KPIs

Link to risks

Commentary

 ▶ Group sales growth 

 ▶ Operational - The Group 

 ▶ Clinical data collection

is unable to expand in line 
with demand

 ▶ Commercial - Competitor 
product could reach the 
market first, offer pricing 
advantages or outperform 
the Group’s products

 ▶ Clinical – Risk of loss of 
license or restrictions 

Despite the challenges 
that COVID-19 presented to 
the commercial landscape 
during 2020, the Group was 
successful in broadening our 
base of strategic partnerships 
and OEM agreements, and 
remains well positioned to 
build on these relationships 
moving forward. 

Our success is reliant 

 ▶ Launched new 

 ▶ Expand 

 ▶ Clinical data collection 

 ▶ Clinical and Regulatory – 

 ▶ Improve breath of product 

portfolio and pipeline 

 ▶ IP collaboration 

Loss of license or 
restriction due to 
regulatory failings

 ▶ Commercial – Competitor 
product could reach the 
market first or outperform 
the Group’s products 

 ▶ Finance – Insufficient 

funds to commence or 
complete trials 

 ▶ Operational – The Group 

is unable to expand in line 
with demand

 ▶ Clinical and Regulatory – 

Changes to the regulatory 
landscape for our products 

During 2020, we brought to 
market two new products 
that diversify our product 
portfolio and also provide 
additional opportunities 
with new strategic partners 
and expand our geographic 
footprint. 

During 2021, we intend 
to expand the market 
penetration and opportunities 
for these products as well as 
develop further product line 
extensions to address specific 
clinical applications where 
we see a market opportunity 
and have the capabilities to 
execute quickly. 

Broaden 

strategic 

partnerships

Strengthen 

portfolio

 ▶ Entered white label 

 ▶ Ramp up market 

manufacturing 

agreement for new 

product with top 10 

global healthcare 

company

penetration 

of our smaller 

product lines in 

collaboration with 

strategic partners 

 ▶ Secured additional 

 ▶ Launch new 

strategic and 

distribution 

partners for 

existing product 

portfolio 

 ▶ Launched 

OrthoPure® XT 

into the European 

market securing 

distribution 

partners in the 

UK, Poland and 

product 

developments with 

strategic partners 

 ▶ Enter new clinical 

applications 

and geographic 

territories with 

new and existing 

strategic partners 

highlight our clinical 

Portugal 

product in 

collaboration 

with top 10 

global healthcare 

company 

 ▶ Received CE 

Mark approval for 

OrthoPure® XT 

to commence 

European roll out 

 ▶ Collated two year 

clinical data for 

opportunities for 

OrthoPure® XT in 

the UK and select 

European markets

 ▶ Launch new 

product 

developments with 

strategic partners, 

specifically for 

urogynaecology 

and wound care 

applications 

studies 

 ▶ 19 new DermaPure® 

clinical case studies 

 ▶ Two new BioRinse® 

clinical case studies 

technology platforms 

publicly available 

marketing clinical 

OrthoPure® XT, now 

 ▶ Commence post 

Our commercial 

strategy focuses on 

establishing and 

building strategic 

partnerships to 

further our market 

penetration. 

This allows for the 

potential to increase 

OEM agreements and 

initiate discussions 

around joint IP 

collaborations, as 

well as extending 

our geographic 

reach. Key to this, is 

also increasing our 

real world clinical 

data collection to 

differentiators 

for customers, 

reimbursement 

agencies, and 

strategic partners. 

upon the ability to 

commercialise our 

current product 

portfolio and 

the potential for 

augmenting this 

with product line 

extensions and new 

innovative products. 

We look to establish 

a database of 

compelling clinical 

data to validate our 

and further our 

physician conversion 

rates. 

These clinical data 

portfolios are also 

imperative when 

we seek new 

strategic partnership 

opportunities 

for negotiating 

favourable 

reimbursement 

pricing and when 

navigating regulatory 

clearance in new 

territories.

Read more about 
our KPIs on pages 
22 and 23

Read more about 
our Risks on pages 
38 and 43

19

STRATEGIC REPORT:

S
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A
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Strategic objectives

Accelerate US 
market penetration
Focus 
Drive sales growth of 
product portfolios in the US 
market through current and 
potential direct and indirect 
distribution channels and 
increasing GPO relationships 
and penetration

Near 6–12 months
 ▶ Bring onstream phase 1 

of the capacity expansion 
programme

 ▶ Assess commencement 

of phase 2 of the capacity 
expansion programme

 ▶ Bring to market new 

product line extensions 

 ▶ Further develop strategic 
partnerships and identify 
additional partnerships 
which will complement 
our growing portfolio

 ▶ Increase collection of real 

world clinical data

Mid 12–18 months
 ▶ Look to secure new 
significant strategic 
partnerships 

 ▶ Continue to identify 

product opportunities and 
commercial partnerships

Long 18+ months
 ▶ Further collaboration 

with strategic partners 
for future product 
development, including 
combination products 

Exploit global 
market potential
Focus 
Continue to build global sales 
reach through expansion of 
distribution partnerships and 
licensing agreements 

Broaden strategic 
partnerships
Focus 
Pursue further, and develop 
existing distribution, 
licensing or IP collaboration 
partnerships 

Near 6–12 months
 ▶ Continued expansion 

Near 6–12 months
 ▶ Enter new clinical 

of UK and EU BioRinse® 
distribution opportunities

 ▶ Roll out of OrthoPure® XT 
distribution partnerships 
in the EU 

Mid 12–18 months
 ▶ Expand network of 

distributors outside of the 
main US and EU markets

 ▶ Pursue licensing and 

partnership opportunities 
to expand geographic 
reach

Long 18+ months
 ▶ Focus on business 
development for 
geographic expansion

application areas and 
launch product line 
extensions with existing 
partners 

 ▶ Sign agreements with 
additional strategic 
partners

Mid 12–18 months
 ▶ Increase licensing and 
strategic partnerships

Long 18+ months
 ▶ Pursue further joint IP 

opportunities

20

TISSUE REGENIX GROUP PLCANNUAL REPORT AND ACCOUNTS FOR THE YEAR ENDED 31 DECEMBER 2020 
  
 
 
Strategic objectives

Strengthen 
Portfolio
Focus 
Bring new products and 
product line extensions 
to market from pipeline 
of products currently in 
development

Near 6–12 months
 ▶ Launch new product line 

developments

 ▶ Expand rollout of 

OrthoPure® XT in the 
UK and select European 
markets

Mid 12–18 months
 ▶ Pursue internal and 

external opportunities to 
broaden product portfolio

Long 18+ months
 ▶ Collaboration with 
strategic partners 
for future product 
development 

21

STRATEGIC REPORTS
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KPI

Financial

Cash position

Definition

Why this is important

Commentary

Link to strategic 

growth drivers 

Maintaining sufficient cash resources 
to enable the business to develop.

Ensuring sufficient cash resources to support the 
investment and working capital requirements of 
the Group for the long-term success of the business.

In June 2020, the Group secured £13.8m (net) of equity funding which has allowed for the commencement of 

phase one of the capacity expansion programme in the US and offers sufficient working capital to support the 

A blend of all four 

strategic growth 

Group for the foreseeable future. Cash must now be carefully managed to ensure the efficient deployment of 

drivers 

Group sales 
growth

An increase in top-line revenue 
delivered across key commercial 
divisions. 

In order to reach sustainable long-term objectives, 
Group sales must increase to justify investment 
into further development and make returns to 
shareholders. 

Clinical

Clinical data 
collection

IP 
collaboration 
and 
exploitation

Commercial

Improve 
product 
portfolio and 
pipeline 

Increase 
number of 
strategic 
partners and 
distribution 
opportunities

Operational

Increase  
manufacturing 
capacity 

HR

Staff 
retention and 
development

Clinical data is increasing in 
importance as physicians and 
healthcare providers seek the best 
products for both clinical outcomes 
and economic value.

The regulatory pathways for our porcine products 
is dependent upon the ability to produce, run and 
monitor a successful clinical trial. Clinical data is 
collected in post marketing studies for our allograft 
and xenograft products to demonstrate our 
differentiating factors and reinforce the economic 
and clinical benefits, driving clinical adoption. 

Intellectual property is at the heart 
of our business for both dCELL® and 
BioRinse® portfolios. 

Our business is built around two platform 
technologies and our ability to successfully protect, 
commercialise and differentiate our products. 

Collaboration allows us to expand the 
potential of these IP platforms as we 
explore licensing deals and future 
R&D opportunities. 

IP collaboration allows us to leverage our R&D 
capabilities while utilising the large marketing and 
distribution arms of our partners. 

In order to ensure the business can 
continue to develop there is a need 
to continually assess, and when 
appropriate, develop and launch 
product line extensions where market 
needs are identified.

Strategic partnerships are key to our 
commercialisation strategy, allowing 
us to access partners’ distribution 
networks, potential licensing 
opportunities and R&D collaboration.

In order to improve our competitive advantage, it is 
important that we augment our product portfolio 
with product line extensions, which address market 
needs, increase our market penetration and 
complement the existing product portfolio; these 
line extensions generally have an expedited route 
to market, established distribution pathways and 
favourable margins.

To enable our products to reach the largest possible 
audience, it is important that we continually 
develop our routes to market and expand our 
network with new partners.

We must ensure that we have 
enough processing capacity to 
meet the growing demand, with the 
correct technical and operational 
experts to facilitate this. 

As we look to grow our top-line revenue, and further 
market penetration with our strategic partners, we 
must be able to process enough inventory to meet 
demand. 

Without this, we risk losing potential partners as 
they move their requirements elsewhere.

The retention and development 
of employees is key as we invest 
in relevant training, qualifications 
and career development, while also 
ensuring that succession plans are 
in place. 

Our industry is highly skilled and reliant upon 
employees with the correct qualifications, training 
and experience. Therefore, staff retention is key and 
the ability to attract and maintain the best talent in 
the industry provides us with a competitive edge. 

Environmental Sustainability 

Responsible 
energy 
consumption

With increasing scrutiny on 
businesses’ environmental footprints, 
it is imperative that we take all 
available measures to reduce our 
energy consumption and operate in a 
sustainable and responsible manner. 

Our facilities require specific storage, temperature 
and air quality, all of which can consume a large 
volume of energy, especially when required 24 
hours a day. We must ensure that we take all 
available options to reduce our energy consumption 
and increase our environmental sustainability. 

capital and an appropriately sized overhead cost base. 

2020 was a challenging year commercially due to the impact of COVID-19 on the healthcare markets, but despite 

A blend of all four 

this, we maintained our overall top-line revenue. However, with the launch of two new product lines, additional 

strategic growth 

strategic partnerships and the commencement of the capacity expansion programme, the Group is now better 

drivers 

positioned to grow top-line revenue during 2021 and beyond once healthcare markets and elective procedures 

return to a more normalised level.

Real world clinical data is increasingly important to our commercial success as we showcase the differentiating 

Accelerate market 

properties of our novel product portfolios. During 2020 we continued to collect clinical data for OrthoPure® XT and 

penetration 

made publicly available the pre-clinical and two-year follow-up data. A number of case studies were undertaken 

by our Key Opinion Leaders (‘KOL’) for DermaPure® highlighting the different clinical applications in which it can 

be successfully utilised. As we continue to grow the availability of clinical data for our BioRinse® portfolio, we have 

Strengthen 

portfolio

commenced a number of case studies both with our strategic partners, and KOLs, results of which we would 

expect to publish during 2021. 

We continuously review our IP portfolio to ensure that we have in place the correct level of protection for patents 

Strengthen 

and processes and to monitor and ensure that infringement does not occur. 

Although the dCELL® process is patent protected, we keep the BioRinse® process as a trade secret to protect this IP.

Accelerate market 

portfolio 

penetration 

Securing the equity funding in June 2020 allowed for the commencement of phase one of the capacity expansion 

Accelerate US 

programme in San Antonio. The addition of new freezer facilities will triple the Company’s donor tissue storage 

market penetration

capacity and the new distribution area will enable the Company to integrate distribution and finished goods into 

a more efficient operating space. Commencement of phase two will be monitored and initiated when appropriate 

to ensure that the capital investment is deployed efficiently and capacity constraints are not experienced in the 

future. 

Exploit global 

market potential 

Broaden strategic 

partnerships

2020 provided many challenges commercially due to the impact of COVID-19. However, we continued to 

Broaden strategic 

strengthen our relationships with key strategic partners as well as securing additional opportunities, demonstrated 

partnerships

by our white label manufacturing agreement. With a focus on augmenting our sales portfolio we also pursued a 

number of additional opportunities for our amniotic membrane product and secured distribution partners in key 

European territories for OrthoPure® XT. 

During 2020, we launched two new product lines which augment our sales portfolio. Firstly, a soft tissue 

Strengthen 

orthopaedics product under a white label manufacturing agreement with a top 10 global healthcare company, in 

portfolio 

the US market; and OrthoPure® XT, a decellularised porcine tendon, for distribution in select European markets. 

Accelerate market 

penetration 

Following the restructuring of the employee base in 2019, our staff retention throughout 2020 has been extremely 

A blend of all four 

high. The change at the Executive management level, with Daniel Lee stepping into the CEO position, and later 

strategic growth 

David Cocke joining as CFO, will provide stability in the leadership moving forward and the departure of Mike Izon 

drivers 

as R&D Director at the end of the year allowed for the promotion of Christine Rowley to Technical and Operations 

Director, UK. 

As we look to increase our manufacturing capabilities we remain conscious about how this will impact our 

environmental footprint. Throughout 2020, we have continued with the upgrade of lighting in our offices, clean 

A blend of all four 

strategic growth 

rooms and sterile packaging clean rooms to LED. The replacement of our air compressor and drying unit to a more 

drivers 

efficient unit was undertaken to reduce this energy consumption by 70%. Alongside this, there were a number of 

design improvements implemented throughout the new building process to address these issues. 

TISSUE REGENIX GROUP PLCANNUAL REPORT AND ACCOUNTS FOR THE YEAR ENDED 31 DECEMBER 2020 
  
KPI

Financial

Clinical

Clinical data 

collection

IP 

and 

exploitation

Commercial

Improve 

product 

portfolio and 

pipeline 

Increase 

number of 

strategic 

partners and 

distribution 

opportunities

Operational

Increase  

capacity 

HR

Staff 

retention and 

development

Cash position

Maintaining sufficient cash resources 

Ensuring sufficient cash resources to support the 

to enable the business to develop.

investment and working capital requirements of 

the Group for the long-term success of the business.

Group sales 

growth

An increase in top-line revenue 

In order to reach sustainable long-term objectives, 

delivered across key commercial 

Group sales must increase to justify investment 

divisions. 

into further development and make returns to 

shareholders. 

Clinical data is increasing in 

importance as physicians and 

The regulatory pathways for our porcine products 

is dependent upon the ability to produce, run and 

healthcare providers seek the best 

monitor a successful clinical trial. Clinical data is 

products for both clinical outcomes 

collected in post marketing studies for our allograft 

and economic value.

and xenograft products to demonstrate our 

differentiating factors and reinforce the economic 

and clinical benefits, driving clinical adoption. 

Intellectual property is at the heart 

Our business is built around two platform 

collaboration 

of our business for both dCELL® and 

technologies and our ability to successfully protect, 

BioRinse® portfolios. 

commercialise and differentiate our products. 

Collaboration allows us to expand the 

IP collaboration allows us to leverage our R&D 

potential of these IP platforms as we 

capabilities while utilising the large marketing and 

explore licensing deals and future 

distribution arms of our partners. 

R&D opportunities. 

Definition

Why this is important

Commentary

In June 2020, the Group secured £13.8m (net) of equity funding which has allowed for the commencement of 
phase one of the capacity expansion programme in the US and offers sufficient working capital to support the 
Group for the foreseeable future. Cash must now be carefully managed to ensure the efficient deployment of 
capital and an appropriately sized overhead cost base. 

2020 was a challenging year commercially due to the impact of COVID-19 on the healthcare markets, but despite 
this, we maintained our overall top-line revenue. However, with the launch of two new product lines, additional 
strategic partnerships and the commencement of the capacity expansion programme, the Group is now better 
positioned to grow top-line revenue during 2021 and beyond once healthcare markets and elective procedures 
return to a more normalised level.

Link to strategic 
growth drivers 

A blend of all four 
strategic growth 
drivers 

A blend of all four 
strategic growth 
drivers 

Real world clinical data is increasingly important to our commercial success as we showcase the differentiating 
properties of our novel product portfolios. During 2020 we continued to collect clinical data for OrthoPure® XT and 
made publicly available the pre-clinical and two-year follow-up data. A number of case studies were undertaken 
by our Key Opinion Leaders (‘KOL’) for DermaPure® highlighting the different clinical applications in which it can 
be successfully utilised. As we continue to grow the availability of clinical data for our BioRinse® portfolio, we have 
commenced a number of case studies both with our strategic partners, and KOLs, results of which we would 
expect to publish during 2021. 

Accelerate market 
penetration 

Strengthen 
portfolio

We continuously review our IP portfolio to ensure that we have in place the correct level of protection for patents 
and processes and to monitor and ensure that infringement does not occur. 

Strengthen 
portfolio 

Although the dCELL® process is patent protected, we keep the BioRinse® process as a trade secret to protect this IP.

In order to ensure the business can 

In order to improve our competitive advantage, it is 

continue to develop there is a need 

important that we augment our product portfolio 

to continually assess, and when 

with product line extensions, which address market 

appropriate, develop and launch 

needs, increase our market penetration and 

product line extensions where market 

complement the existing product portfolio; these 

needs are identified.

line extensions generally have an expedited route 

to market, established distribution pathways and 

favourable margins.

Strategic partnerships are key to our 

To enable our products to reach the largest possible 

commercialisation strategy, allowing 

audience, it is important that we continually 

us to access partners’ distribution 

develop our routes to market and expand our 

networks, potential licensing 

network with new partners.

opportunities and R&D collaboration.

Securing the equity funding in June 2020 allowed for the commencement of phase one of the capacity expansion 
programme in San Antonio. The addition of new freezer facilities will triple the Company’s donor tissue storage 
capacity and the new distribution area will enable the Company to integrate distribution and finished goods into 
a more efficient operating space. Commencement of phase two will be monitored and initiated when appropriate 
to ensure that the capital investment is deployed efficiently and capacity constraints are not experienced in the 
future. 

2020 provided many challenges commercially due to the impact of COVID-19. However, we continued to 
strengthen our relationships with key strategic partners as well as securing additional opportunities, demonstrated 
by our white label manufacturing agreement. With a focus on augmenting our sales portfolio we also pursued a 
number of additional opportunities for our amniotic membrane product and secured distribution partners in key 
European territories for OrthoPure® XT. 

We must ensure that we have 

As we look to grow our top-line revenue, and further 

manufacturing 

enough processing capacity to 

market penetration with our strategic partners, we 

meet the growing demand, with the 

must be able to process enough inventory to meet 

During 2020, we launched two new product lines which augment our sales portfolio. Firstly, a soft tissue 
orthopaedics product under a white label manufacturing agreement with a top 10 global healthcare company, in 
the US market; and OrthoPure® XT, a decellularised porcine tendon, for distribution in select European markets. 

correct technical and operational 

demand. 

experts to facilitate this. 

Without this, we risk losing potential partners as 

they move their requirements elsewhere.

Accelerate market 
penetration 

Accelerate US 
market penetration

Exploit global 
market potential 

Broaden strategic 
partnerships

Broaden strategic 
partnerships

Strengthen 
portfolio 

Accelerate market 
penetration 

The retention and development 

Our industry is highly skilled and reliant upon 

of employees is key as we invest 

employees with the correct qualifications, training 

in relevant training, qualifications 

and experience. Therefore, staff retention is key and 

and career development, while also 

the ability to attract and maintain the best talent in 

ensuring that succession plans are 

the industry provides us with a competitive edge. 

Following the restructuring of the employee base in 2019, our staff retention throughout 2020 has been extremely 
high. The change at the Executive management level, with Daniel Lee stepping into the CEO position, and later 
David Cocke joining as CFO, will provide stability in the leadership moving forward and the departure of Mike Izon 
as R&D Director at the end of the year allowed for the promotion of Christine Rowley to Technical and Operations 
Director, UK. 

A blend of all four 
strategic growth 
drivers 

in place. 

Environmental Sustainability 

Responsible 

energy 

consumption

With increasing scrutiny on 

Our facilities require specific storage, temperature 

businesses’ environmental footprints, 

and air quality, all of which can consume a large 

it is imperative that we take all 

volume of energy, especially when required 24 

available measures to reduce our 

hours a day. We must ensure that we take all 

energy consumption and operate in a 

available options to reduce our energy consumption 

sustainable and responsible manner. 

and increase our environmental sustainability. 

As we look to increase our manufacturing capabilities we remain conscious about how this will impact our 
environmental footprint. Throughout 2020, we have continued with the upgrade of lighting in our offices, clean 
rooms and sterile packaging clean rooms to LED. The replacement of our air compressor and drying unit to a more 
efficient unit was undertaken to reduce this energy consumption by 70%. Alongside this, there were a number of 
design improvements implemented throughout the new building process to address these issues. 

A blend of all four 
strategic growth 
drivers 

23

STRATEGIC REPORTTISSUE REGENIX GROUP PLC

We have a senior management team with extensive experience in 
the healthcare industry. They are challenged and supported by an 
experienced and well-balanced Board of Non-Executive Directors, 
together with the teams of employees that they lead.

Daniel Lee
Chief Executive Officer  
(CEO)

David Cocke
Chief Financial Officer
(CFO)

Daniel Lee has nearly 30 years’ 
experience in the medical device 
and biologics industry, ranging 
from product innovation to 
commercialisation to corporate 
management. Daniel was appointed 
CEO in November 2020 after initially 
joining Tissue Regenix Group as 
President of U.S. Operations in 
January 2019. Prior to this, Danny was 
the Chief Executive Officer for Scaffold 
Biologics and Aperion Biologics. 
His previous senior management 
roles include global marketing for 
OsteoBiologics (acquired by Smith 
& Nephew Endoscopy in 1996) and 
marketing activities for Regeneration 
Technologies (now RTI Surgical), a 
leading allograft tissue processor. 

Danny spent the first 10 years of his 
career in R&D with the U.S. Surgical 
Corporation (now Medtronic). Danny 
received his B.E.S. degree in Materials 
Science and Engineering from the 
Johns Hopkins University, and his M.S. 
in Biomedical Engineering from the 
University of Alabama at Birmingham. 
He has 13 patents on implants and 
instruments used in orthopaedic and 
general surgery.

Danny is also a Certified Tissue Bank 
Specialist (CTBS) from the American 
Association of Tissue Banks (AATB). 

David C. Cocke has over 29 years of 
experience in the medical device 
industry holding senior finance and 
operations positions. In 1997, David 
was a founding partner of NuPak 
Medical, an ISO-certified contract 
manufacturer of sterile disposable 
medical devices. NuPak Medical was 
acquired by Katena Products, Inc. in 
2017 and David remained with the 
business post-acquisition until joining 
Tissue Regenix in January 2021. David 
was also Chief Financial Officer at 
Aperion Biologics from 2008-2017. 
Prior to this, David was Senior Director 
for Finance and Operations at Kinetic 
Concepts from 1993-1996. 

David began his career in the 
corporate finance sector, working at 
GE Capital in its Corporate Finance 
Group and at Salomon Brothers Inc in 
its Investment Banking Group. 

David received his B.B.A in Business 
Honors (magna cum laude) from the 
University of Texas at Austin and his 
M.B.A from the University of Virginia’s 
Darden Graduate School of Business 
Administration. He has two patents 
covering medical devices.

Gerald Sharpe

Vice President - Strategic 

Partnerships

Christine Rowley

Technical and Operations  

Director, UK 

Gerald Sharpe has over 10 

years’ experience in the 

orthobiologics industry, working 

for two differentiated allograft 

tissue processors. His focus is 

commercialisation and business 

development. He joined CellRight 

Technologies as Regional Sales 

Christine has over 16 years’ experience 

in the medical device biologics 

industry, joining Tissue Regenix in 

2010. She has worked in all areas 

of product development and 

commercialisation, and has led the 

development of the OrthoPure® 

XT device from product feasibility 

Manager in September 2014, before 

through to market approval and 

being appointed as Vice President - 

launch. Christine’s experience covers 

Strategic Partnerships in January 2019. 

a wide range of activities, including 

Gerald is proficient in spine, sports 

new product development, process 

medicine, foot and ankle, dental, and 

optimisation and design transfer, 

ocular aspects of the business.

Prior to joining CellRight, Gerald was 

Regional Sales Manager and Director 

of Client Services for TissueNet. His 

previous sales roles include Vice 

for SolomonFX.

Gerald received his Bachelor of 

Science degree in Marketing from the 

University of Central Florida. 

President of Business Development 

Christine has held leadership roles 

design verification and validation, 

clinical trial design and execution, 

regulatory submissions, and quality 

control, almost exclusively working 

with class III xenograft implants.

within the product development, 

regulatory, clinical and quality sectors, 

and has achieved market clearance of 

xenograft medical devices in multiple 

countries worldwide. Christine has 

several patents associated with the 

decellularisation and manipulation 

of collagenous tissues for potential 

health care benefits. Christine 

has a Bachelor of Science degree 

in Biological Sciences from the 

University of Exeter (UK).

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ANNUAL REPORT AND ACCOUNTS FOR THE YEAR ENDED 31 DECEMBER 2020 
  
 
Daniel Lee

Chief Executive Officer  

(CEO)

David Cocke

Chief Financial Officer

(CFO)

Daniel Lee has nearly 30 years’ 

experience in the medical device 

and biologics industry, ranging 

from product innovation to 

commercialisation to corporate 

management. Daniel was appointed 

David C. Cocke has over 29 years of 

experience in the medical device 

industry holding senior finance and 

operations positions. In 1997, David 

was a founding partner of NuPak 

Medical, an ISO-certified contract 

CEO in November 2020 after initially 

manufacturer of sterile disposable 

joining Tissue Regenix Group as 

President of U.S. Operations in 

medical devices. NuPak Medical was 

acquired by Katena Products, Inc. in 

January 2019. Prior to this, Danny was 

2017 and David remained with the 

the Chief Executive Officer for Scaffold 

business post-acquisition until joining 

Biologics and Aperion Biologics. 

His previous senior management 

roles include global marketing for 

OsteoBiologics (acquired by Smith 

& Nephew Endoscopy in 1996) and 

Tissue Regenix in January 2021. David 

was also Chief Financial Officer at 

Aperion Biologics from 2008-2017. 

Prior to this, David was Senior Director 

for Finance and Operations at Kinetic 

marketing activities for Regeneration 

Concepts from 1993-1996. 

Technologies (now RTI Surgical), a 

leading allograft tissue processor. 

Danny spent the first 10 years of his 

career in R&D with the U.S. Surgical 

David began his career in the 

corporate finance sector, working at 

GE Capital in its Corporate Finance 

Group and at Salomon Brothers Inc in 

Corporation (now Medtronic). Danny 

its Investment Banking Group. 

received his B.E.S. degree in Materials 

Science and Engineering from the 

Johns Hopkins University, and his M.S. 

in Biomedical Engineering from the 

University of Alabama at Birmingham. 

He has 13 patents on implants and 

instruments used in orthopaedic and 

general surgery.

Danny is also a Certified Tissue Bank 

Specialist (CTBS) from the American 

Association of Tissue Banks (AATB). 

David received his B.B.A in Business 

Honors (magna cum laude) from the 

University of Texas at Austin and his 

M.B.A from the University of Virginia’s 

Darden Graduate School of Business 

Administration. He has two patents 

covering medical devices.

Gerald Sharpe
Vice President - Strategic 
Partnerships

Christine Rowley
Technical and Operations  
Director, UK 

Gerald Sharpe has over 10 
years’ experience in the 
orthobiologics industry, working 
for two differentiated allograft 
tissue processors. His focus is 
commercialisation and business 
development. He joined CellRight 
Technologies as Regional Sales 
Manager in September 2014, before 
being appointed as Vice President - 
Strategic Partnerships in January 2019. 
Gerald is proficient in spine, sports 
medicine, foot and ankle, dental, and 
ocular aspects of the business.

Prior to joining CellRight, Gerald was 
Regional Sales Manager and Director 
of Client Services for TissueNet. His 
previous sales roles include Vice 
President of Business Development 
for SolomonFX.

Gerald received his Bachelor of 
Science degree in Marketing from the 
University of Central Florida. 

Christine has over 16 years’ experience 
in the medical device biologics 
industry, joining Tissue Regenix in 
2010. She has worked in all areas 
of product development and 
commercialisation, and has led the 
development of the OrthoPure® 
XT device from product feasibility 
through to market approval and 
launch. Christine’s experience covers 
a wide range of activities, including 
new product development, process 
optimisation and design transfer, 
design verification and validation, 
clinical trial design and execution, 
regulatory submissions, and quality 
control, almost exclusively working 
with class III xenograft implants.

Christine has held leadership roles 
within the product development, 
regulatory, clinical and quality sectors, 
and has achieved market clearance of 
xenograft medical devices in multiple 
countries worldwide. Christine has 
several patents associated with the 
decellularisation and manipulation 
of collagenous tissues for potential 
health care benefits. Christine 
has a Bachelor of Science degree 
in Biological Sciences from the 
University of Exeter (UK).

STRATEGIC REPOR T

25

TISSUE REGENIX GROUP PLC

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Tina Trimble 
VP, Donor Services, US 

Lance Johnson
VP, Quality and  
Regulatory, US 

Kirsten Lund

Group Finance Director  

and Company Secretary 

Patti Gary

Vice President,  

Clinical Affairs 

Tina Trimble has 30+ years’ of tissue 
banking industry experience and 
joined CellRight Technologies as VP, 
Donor Services in March 2019. Tina 
has worked with other tissue banks in 
leadership roles such as Community 
Tissue Services, Regeneration 
Technologies, Tutogen Medical and 
most recently, Bone Bank Allografts. 

Tina is a Certified Tissue Bank 
Specialist, and currently serves on the 
American Association of Tissue Banks 
(AATB) Exam Committee, American 
Board of Accredited Tissue Banks, 
Birth Tissue Council and most recently 
on the AATB Board of Governors 
2018-2020 and Chair of the Processing 
and Distribution Council. Prior to that, 
Tina served on the AATB Accreditation 
Committee, VC Processing and 
Distribution Council, Education and 
Program committees and is currently 
a member of AORN and ASQ.

Lance Johnson has over 30 years’ 
experience in FDA Requirements 
and Quality Systems. His experience 
includes over 10 years at the executive 
level for primarily class III medical 
device implant companies. Prior to 
joining CellRight Technologies as VP, 
QA/RA, Lance was the Vice President 
of Quality for EndoStim Inc, an active 
implant device manufacturer located 
in Austin, TX. Lance also worked in 
the xenograft device industry as VP 
of Quality for Aperion Biologics, and 
in the orthopedic spine industry as 
Quality Manager for Zimmer Spine 
and Abbott Spine. 

In addition to his industry experience, 
he spent 16 years as an active 
investigator with the FDA. Lance 
specialised in medical device 
compliance and worked in both the 
San Francisco and Dallas districts. 
He spent 12 years as the resident 
in charge of the Austin, Texas field 
office and as contributor to the FDA 
international cadre. 

Lance received his Bachelor of 
Science degree in Biotechnology from 
Oklahoma State University. 

Kirsten Lund was promoted to the 

position of Group Finance Director 

Patti J. Gary has nearly 30 years of 

experience in the medical device 

in November 2019 after being Group 

and tissue industry. Her experience 

Financial Controller for over a year. 

Kirsten supports the CFO and leads 

the finance teams in both the UK 

and US, and advised the Board on 

all financial matters relating to the 

Group. 

provides a unique combination of 

sales and clinical roles. She joined 

Tissue Regenix as Senior Director 

of Clinical Affairs in July 2013, before 

being appointed to VP of Clinical 

Affairs in March 2015.

After joining Tissue Regenix in 2010 as 

Prior to joining Tissue Regenix, Patti 

Finance and Administration Assistant, 

was Sales Director for PolyRemedy. 

Kirsten successfully completed 

the ACCA qualification, achieving 

chartered status in 2015. Kirsten has 

been a key member of the team 

Her previous roles include Professional 

Education Manager, Corporate 

Healthcare Director and Director 

of Clinical Services for Systagenix 

throughout the last 10 years. Utilising 

(acquired by Acelity). Prior to 

the knowledge acquired over the 

Systagenix, Patti was Post-Acute 

years in the healthcare sector, Kirsten 

National Accounts Director and 

provides invaluable experience and 

District Sales Manager for Acelity. Her 

understanding around the Company 

journey in industry began at Hill-Rom 

structure and routes to market, and 

as an Account Manager. Patti was also 

works closely with the management 

the owner and President of Positive 

team to help drive forward the 

strategy of the business.

Outcomes, Inc. where she developed 

clinical and financial tools (HealQuest, 

HealPROtocols and Healware) to drive 

standardized processes for wound 

management. HealPROtocols was 

acquired by Acelity. Her depth of 

knowledge spans clinical, regulatory, 

reimbursement and sales, all of which 

have contributed to her success. Patti 

is a Registered Nurse and a Certified 

Wound Care Nurse. She graduated 

from Louisiana State University Health 

Sciences Center School of Nursing. 

ANNUAL REPORT AND ACCOUNTS FOR THE YEAR ENDED 31 DECEMBER 2020 
  
 
Tina Trimble 

VP, Donor Services, US 

Lance Johnson

VP, Quality and  

Regulatory, US 

Tina Trimble has 30+ years’ of tissue 

banking industry experience and 

Lance Johnson has over 30 years’ 

experience in FDA Requirements 

joined CellRight Technologies as VP, 

and Quality Systems. His experience 

Donor Services in March 2019. Tina 

includes over 10 years at the executive 

has worked with other tissue banks in 

level for primarily class III medical 

leadership roles such as Community 

device implant companies. Prior to 

Tissue Services, Regeneration 

Technologies, Tutogen Medical and 

joining CellRight Technologies as VP, 

QA/RA, Lance was the Vice President 

most recently, Bone Bank Allografts. 

of Quality for EndoStim Inc, an active 

Tina is a Certified Tissue Bank 

Specialist, and currently serves on the 

American Association of Tissue Banks 

(AATB) Exam Committee, American 

Board of Accredited Tissue Banks, 

Birth Tissue Council and most recently 

on the AATB Board of Governors 

implant device manufacturer located 

in Austin, TX. Lance also worked in 

the xenograft device industry as VP 

of Quality for Aperion Biologics, and 

in the orthopedic spine industry as 

Quality Manager for Zimmer Spine 

and Abbott Spine. 

2018-2020 and Chair of the Processing 

In addition to his industry experience, 

and Distribution Council. Prior to that, 

he spent 16 years as an active 

Tina served on the AATB Accreditation 

investigator with the FDA. Lance 

Committee, VC Processing and 

specialised in medical device 

Distribution Council, Education and 

compliance and worked in both the 

Program committees and is currently 

San Francisco and Dallas districts. 

a member of AORN and ASQ.

He spent 12 years as the resident 

in charge of the Austin, Texas field 

office and as contributor to the FDA 

international cadre. 

Lance received his Bachelor of 

Science degree in Biotechnology from 

Oklahoma State University. 

Kirsten Lund
Group Finance Director  
and Company Secretary 

Patti Gary
Vice President,  
Clinical Affairs 

Kirsten Lund was promoted to the 
position of Group Finance Director 
in November 2019 after being Group 
Financial Controller for over a year. 
Kirsten supports the CFO and leads 
the finance teams in both the UK 
and US, and advised the Board on 
all financial matters relating to the 
Group. 

After joining Tissue Regenix in 2010 as 
Finance and Administration Assistant, 
Kirsten successfully completed 
the ACCA qualification, achieving 
chartered status in 2015. Kirsten has 
been a key member of the team 
throughout the last 10 years. Utilising 
the knowledge acquired over the 
years in the healthcare sector, Kirsten 
provides invaluable experience and 
understanding around the Company 
structure and routes to market, and 
works closely with the management 
team to help drive forward the 
strategy of the business.

Patti J. Gary has nearly 30 years of 
experience in the medical device 
and tissue industry. Her experience 
provides a unique combination of 
sales and clinical roles. She joined 
Tissue Regenix as Senior Director 
of Clinical Affairs in July 2013, before 
being appointed to VP of Clinical 
Affairs in March 2015.

Prior to joining Tissue Regenix, Patti 
was Sales Director for PolyRemedy. 
Her previous roles include Professional 
Education Manager, Corporate 
Healthcare Director and Director 
of Clinical Services for Systagenix 
(acquired by Acelity). Prior to 
Systagenix, Patti was Post-Acute 
National Accounts Director and 
District Sales Manager for Acelity. Her 
journey in industry began at Hill-Rom 
as an Account Manager. Patti was also 
the owner and President of Positive 
Outcomes, Inc. where she developed 
clinical and financial tools (HealQuest, 
HealPROtocols and Healware) to drive 
standardized processes for wound 
management. HealPROtocols was 
acquired by Acelity. Her depth of 
knowledge spans clinical, regulatory, 
reimbursement and sales, all of which 
have contributed to her success. Patti 
is a Registered Nurse and a Certified 
Wound Care Nurse. She graduated 
from Louisiana State University Health 
Sciences Center School of Nursing. 

STRATEGIC REPOR T

27

The completion of the £14.6m (gross) equity 
fundraise in June 2020 has provided a strong 
cash position for the Group, with these 
resources allowing for investment into phase 
1 of the capacity expansion programme 
in San Antonio. It will provide sufficient 
working capital to support the Group for the 
foreseeable future. 

Read more about our Financial overview  
on pages 34 and 37

Operations 
Operationally, 2020 was a successful year 
for the Group with the additional funding 
allowing for the commencement of the 
capacity expansion programme in San Antonio. 
Previously, the Group was hindered by a lack of 
freezer storage and distribution facilities which 
restricted the number of donors we could 
hold on site for processing; and efficiencies 
in our ability to ship finished goods in-line 
with peak demand. The new distribution 
facility consolidates this function into a single 
location and provides labour and time savings 
in processing orders. Phase 1 of the capacity 
expansion will move all freezer space into the 
new facility increasing our capacity. This in turn 
will allow for two additional sterile packaging 
clean rooms to be installed in the space 
formerly occupied by freezers in the original 
building. These changes alone should provide 
additional flexibility and increase our BioRinse® 
portfolio processing capacity by c.50%, which 
we expect will be easily absorbed by the 
demand we see from existing partners and 
customers. This expansion will also improve 
the efficiency for processing the DermaPure® 
portfolio of products. Furthermore, we intend 
to build up to an additional 10 clean rooms in 
the new facility in phase 2, which will allow 
for the continued expansion of our customer 
base, product portfolio and geographic 
reach. Due to the impact of COVID-19 on the 
healthcare markets, the initiation of this phase 
has been placed under review to ensure the 
efficient deployment of capital and a return 
to normalised market conditions. Once 
Phase 2 is fully operational, it is expected that 
this expansion programme will meet our 
processing requirements for the next 5-7 years.

The relocation of our UK facility was 
undertaken in October 2020 once the required 
inventory for the launch of OrthoPure® XT had 
been processed. As part of this relocation, 
many aspects of the production process have 
been successfully outsourced reducing our 
dependency on in-house manufacturing. 

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The Group performed strongly 
during 2020 despite the 
COVID-19 backdrop, delivering 
top-line revenues consistent 
with 2019 and achieving 
significant operational and 
commercial success. We 
improved our performance 
against key performance 
indicators in a year where 
many companies experienced 
a downturn in demand as 
hospital resources were 
redirected, and this is a 
testament to our products, 
partners and employees.

Financial Performance
Our Orthopaedics and Dental division 
is comprised primarily of our BioRinse® 
portfolio, reported sales of £7,446K (2019: 
£6,724K), an increase of 11% driven largely by 
strong performances by our partners, the 
diversity of our markets, and the addition of 
distributors for smaller product lines. The most 
significant increase was seen in our amniotic 
membrane product line which was achieved 
primarily through strategic partnerships in 
ophthalmology, a growth opportunity for 
the Company. Over time, sales from the 
OrthoPure® XT product line will be captured 
under this division however, with its launch in 
November 2020 the contribution to the 2020 
revenue line was not material. 

The BioSurgery division maintained its 
increased focus on soft tissue orthopaedic 
and urogynaecology procedures which were 
established during 2019, however, these areas 
were more significantly impacted by the 
postponement and cancellation of elective 
surgical procedures caused by the COVID-19 
pandemic, and consequently lead to a 22% 
reduction for revenues under this division. We 
continue to work closely with our customers, 
distributors and strategic partners and it 
is expected that once these procedures 
recommence, the demand for our DermaPure® 
and DermaPure® non-oriented products will 
continue to increase. 

Alongside this, the Group initiated a number 
of overhead cost reduction initiatives, which 
reduced our overhead cost base by £1.7m, and 
the full annualised saving of c.£400k from the 
UK facility move in October 2020 will not be 
fully realised until 2021. We have continued to 
focus on our overhead cost base and following 
the year end announced restructuring of the 
US business which once annualised will realise 
a further c.$700k saving. 

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TISSUE REGENIX GROUP PLCANNUAL REPORT AND ACCOUNTS FOR THE YEAR ENDED 31 DECEMBER 2020 
  
STRATEGIC REPOR T

“

I am honoured to have been appointed as CEO 
to lead the Group through its next stages of 
development. 2020 was a challenging year, 
but under the circumstances, a successful 
period for the Group. The year was primarily 
highlighted by our financial performance relative 
to other industry participants, and securing the 
necessary funding to support the organisation 
and invest in the required capacity expansion 
programme. Alongside this, we secured a 
number of additional distribution and white label 
agreements for organic growth in the US and 
extending our geographical outreach through 
the receipt of the CE Mark for OrthoPure®XT 
which allowed us to begin our commercialisation 
efforts within the EU. Having been with 
the Group for two years as President of US 
Operations, I was familiar with much of  
the business. However, since moving into this 
role, I can see expansive opportunities that 
lie before us to enable our global growth in 
regenerative medicine.”

Daniel Lee 
Chief Executive Officer

29

In January 2020, the Group was the victim of 
a cyber attack, which temporarily affected our 
ability to process at the facility in San Antonio. 
We quickly implemented an action plan to 
provide forensic data, remediate our services 
and mitigate the potential consequences. 
Although there was a short-term impact on our 
ability to service customer demand as we were 
unable to release inventory for distribution 
in-line with the necessary quality regulations, 
during the weeks that followed the attack, the 
San Antonio team worked to catch up with this 
demand. The Company reported the attack 
to all relevant authorities, has reviewed its IT 
service providers and implemented additional 
data security procedures to reduce the risk of a 
similar incident occurring in the future. 

The impact of COVID-19 
The pandemic stunted the surgical 
marketplace when hospitals, governments 
and health care providers halted elective 
procedures across all specialties. The 
postponement of surgical procedures, 
which was initially most evident in the 
urogynaecology and dental applications, 
has led to business disruption in terms of 
unpredictable inventory and manufacturing 
forecasts.

By undertaking certain initiatives, which 
were updated throughout the year based on 
guidelines issued by the government and 
other credible sources, there was minimal 
disruption to the processing undertaken at 
the facility in San Antonio, which continued to 
show strong production throughput. Although 
COVID-19 did not impact production in San 
Antonio, it did have an impact on our supply 
chain of donors. To address the delays in donor 
sourcing, we broadened our donor sourcing 
agencies by taking into account factors such 
as geography and recovery structures. As the 
impact of COVID-19 became more evident, 
we monitored and adapted our approach 
through a combination of communication 
with partners and altering our processing 
and production priorities. During Q3, regional 
markets started to regain momentum but 
COVID-19 continued to have an impact 
nationally as 2020 came to an end.

Strategy 
Whilst in the position as President of US 
Operations, I was involved in shaping the 
strategic direction for the US business and the 
required capacity expansion project. Therefore, 
the strategy as highlighted by the previous 
Executive management at the time of the 
fundraise is one that I continue to endorse and 
look to our strategic growth drivers as the map 
to our future success. During 2020, we were 
successful in securing a number of commercial 
and operational milestones and improving 
our performance against key performance 
indicators, such as increasing our strategic 
partnerships and therefore, US market 
penetration. 

Commercial and R&D
Following the restructuring of the business 
in late 2019, we continue to pursue the 
commercialisation of current product lines 
as our top priority and look to augment this 
with product line extensions that are faster 
to market and address a specific clinical 
application and need. One of these areas was 
a focus on our amnion based products which 
has increased nearly four-fold year on year.

During 2020, we launched OrthoPure® XT 
into the UK and select European markets 
following the receipt of CE mark certification. 
OrthoPure® XT is used in the reconstruction 
of the Anterior Cruciate Ligament following 
re-rupture, the reconstruction of other knee 
ligaments in multi-ligament procedures 
following trauma, and primary ACL procedures 
where the autograft is unavailable or 
inadequate.

The Group has been working to launch this 
product for a number of years and successfully 
undertook a comprehensive clinical trial, 
resulting in white papers describing the pre-
clinical and two-year clinical follow-up.

We also strengthened our white label 
manufacturing which will supplement our 
own branded portfolio, increase market 
opportunities and provide revenue generating 
streams for the business. In May, we 
announced that we had signed a white label 
agreement with a top 10 global healthcare 
company for a new soft tissue orthopaedic 
product; this was the culmination of two years 
work between our R&D and commercial teams 
alongside our new partner. Although there 
has been a positive response to this product, 
it is expected that the full impact of this 
product line will not be seen until 2021 once 
the COVID-19 pandemic has subsided. The 
additional capacity provided by the expansion 
programme will allow us to expand our white 
label offering and it is this type of activity which 
we hope to replicate with additional strategic 
partners in the future. During the year we 

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TISSUE REGENIX GROUP PLCANNUAL REPORT AND ACCOUNTS FOR THE YEAR ENDED 31 DECEMBER 2020 
  
also added several additional private label 
agreements for our growth product lines, such 
as AmnioWorks™, which have the potential to 
generate revenue and diversify our spectrum 
of products and specialties moving forward. 

One of our focus areas during 2020 was the 
identification of product line extensions to 
strengthen both our product portfolio and 
market position. We expect that during 2021 
a number of these identified product line 
extensions or improvement opportunities from 
our product portfolio will come to fruition, 
driving the organic growth rate, specifically 
as we look to tailor our soft tissue offering to 
clinical applications where we see a lack of 
suitable biologic alternatives and meet market 
expectations. 

Culture
The Group is reliant upon our employees to 
ensure that the value of our novel technology 
platforms realises its true potential and 
becomes the clinician’s product of choice 
to improve the lives of as many patients as 
possible. 

Central to this is the corporate culture we 
create, and I strongly support the Group’s 
vision, mission, values and behaviours which 
we expect every employee to uphold and 
which guides the corporate strategy and 
decision making. 2020 also provided the 
challenge of COVID-19, requiring a combination 
of remote and on-site working to ensure a safe 
and healthy workplace. This culture ensured 
that the Company is fair, ethical and supportive 
towards all employees and stakeholders, 
making it a place where people want to work, 
and excel, as well as being a Company that 
customers and industry peers want to partner 
with. 

2021 priorities 
The COVID-19 pandemic continues to have a 
significant impact on the healthcare industry. 
However, we remain focused on developing 
the aspects of the business within our control, 
continuing our efforts to more effectively utilise 
our resources and position the Group with a 
competitive edge once the situation begins to 
normalise. 

This includes the completion of Phase 1 of 
the capacity expansion programme and 
ensuring that all operational procedures are 
implemented to allow for a smooth transition 
to the increased processing capacity. With 
this increased capacity, we can continue the 
positive discussions that have commenced 
with existing and new strategic partners. 

Alongside this, we will be in a position to 
commence the processing and launch of 
product line extensions that have been 
identified due to market demand which will 
augment our product portfolio.

31

STRATEGIC REPORTOur commercial focus to this point has 
primarily been on the US market where 
there is significant demand. However, with 
the increased capacity and expansion of 
distribution networks, during 2021 and beyond 
we will seek to expand our geographic 
outreach into new territories for our dCELL® 
and BioRinse® portfolios. Following the 
successful launch of OrthoPure® XT into the UK 
and select EU markets during Q4 2020, we will 
continue to rollout this product into additional 
target markets. 

Post balance sheet events 
As we moved into 2021, the Company was 
still impacted by the COVID-19 pandemic 
as elective surgical procedures in many 
institutions were still on hold and postponed. 
Commercial representatives were prevented 
from entering institutions to meet with 
clinicians and administrators. Many patients 
also delayed surgeries due to COVID-19 
fears, family finances, lost time at work, lack 
of insurance or employment, and other 
considerations. The arrival of vaccines and 
the drop in positivity rates brought hope 
and optimism. There were indications of the 
return of normal market conditions but many 
expect disruptions to continue to mid 2021. 
It remains difficult to predict at what pace a 
return to pre-pandemic procedure levels will 
occur. All of our divisions continued to exercise 
caution and protect the safety and well-being 
of our employees. By continuing the initiatives 

we began in 2020 and implementing any 
relevant government policies, no disruptions in 
operations and no positions were impacted by 
the pandemic. 

On 5 January, we continued to enhance 
our organisational excellence with the 
confirmation of Brian Phillips and Trevor 
Phillips as independent Non-Executive 
Directors of Tissue Regenix. Brian Phillips 
assumed the Chair of the Audit Committee 
and Trevor Phillips assumed the Chair of the 
Remuneration Committee. 

On 21 January, we added David Cocke as our 
Chief Financial Officer and Executive Board 
member. David has over 29 years of experience 
in the medical device industry holding senior 
finance and operations positions. David 
founded NuPak Medical, an ISO-certified 
contract manufacturer of sterile disposable 
medical devices, which was acquired by 
Katena Products, Inc. in 2017. David remained 
with the business post-acquisition until early 
2021, leading the expansion to double the 
clean room capacity and assembly space on 
time and on budget. I had the opportunity to 
work with David at Aperion Biologics where 
he was the Chief Financial Officer and where 
we successfully supported the Board in 
raising $21m from venture capital and private 
investors. David’s experience in financial 
systems, management and operations will be 
invaluable to the Group as we undertake the 
next stages of our growth programme. 

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TISSUE REGENIX GROUP PLCANNUAL REPORT AND ACCOUNTS FOR THE YEAR ENDED 31 DECEMBER 2020 
  
Work has also started on the construction of 
two additional clean rooms at the existing San 
Antonio facility, bringing the total number 
of clean rooms to seven and providing 
additional capacity and flexibility. The move 
of distribution and finished goods to the 
new building provides expansion space for 
supporting departments in our existing facility. 
These developments, which will complete 
phase 1 of the expansion project, are scheduled 
for completion during H1 2021. The decision 
to do this in phases was advantageous by 
enabling us to be efficient with our capital and 
plan our expansion in line with the return to 
pre-pandemic procedure levels. We anticipate 
as the markets normalise and demand 
returns, we can justify the investment into the 
additional phase of the capacity expansion.

Daniel Lee 
Chief Executive Officer

27 April 2021

In late January further re-structuring of the 
US business was undertaken to rationalise 
resources across the business. It is expected to 
reduce the overhead cost base by c.$700k on 
an annualised basis.

On 26 February, we announced that the Board 
had appointed Jonathan Glenn to the position 
of Non-Executive Chairman. Jonathan joined 
the Group in January 2016 and his leadership 
had been invaluable as a Board member and 
as Interim Chairman. We look forward to his 
continued contribution to the Group.

On 18 March, we announced that we have 
completed the initial phase of our expansion 
plans at our San Antonio Texas facility. This 
expansion into the 21,000 sq. ft facility adjacent 
to our existing facility was the first stage of 
our plans to address manufacturing capacity 
constraints. This initial part of the expansion 
project comprised of relocating facilities 
designated for distribution and frozen tissue 
storage, both of which had outgrown their 
existing space in the San Antonio facility. The 
new freezer facility triples the Company’s 
current storage capacity allowing Tissue 
Regenix to hold more donor tissue on site. The 
new distribution area enables the Company to 
integrate distribution and finished goods into a 
more efficient operating space.

33

STRATEGIC REPORTI

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In the year ended 31 December 2020 revenue 
decreased by 2% on an underlying basis or 
0% constant currency basis to £12,829k (2019: 
£13,033k). 

The financial performance for the year was 
impacted by the ongoing COVID-19 pandemic 
which became evident from Q2 onwards, 
together with material cash constraints that 
the business experienced in the first half of the 
period. Notwithstanding this, the Orthopaedics 
& Dental segment successfully grew top 
line sales by 11%, to £7,446k (2019: £6,724k) 
largely driven by a strong Q1 performance. In 
addition, it maintained strong relationships 
with strategic partners and saw an increase in 
the utilisation of a newer, growth product line, 
AmnioWorks™, which will be utilized in surgical 
specialties such as ophthalmology. 

Revenue from DermaPure®, under the 
BioSurgery division, was more significantly 
impacted by the pandemic and associated 
restrictions, as US hospitals postponed elective 
surgical procedures, such as urogynaecology 
and soft tissue orthopaedics, where the 
DermaPure® products would be utilized, 
resulting in a 22% decrease in revenues to 
£3,308k (2019: £4,233k) for this division. There 
is beginning to be a slight uptick in the 
recommencement of these procedures as 
the US vaccine roll-out continues and patient 
confidence returns, however, it remains 
difficult to predict at what pace a return to pre-
pandemic procedural levels will occur. 

The Group’s joint venture, GBM-V, based in 
Rostock, has been impacted by the German 
lockdown restrictions that were in place for 
much of the last year, however, the business 
unit continued to service the cornea market 
where possible and maintained revenues of 
£2,075k (2019: £2,076k) in line with prior year 
results. 

Grant income
During the year, the US subsidiaries of the 
group were successful in the application of the 
US Government PPP loans. The loans have a 
two year term and carry a 1% annual interest 
rate deferred for six months, however, under 
the loan agreement, the total amount of the 
loan will not require repayment if the funds are 
used to support employee payroll, healthcare, 
utilities and rent payment within the US 
during the six months post funding. The Group 
believes they have met the conditions and 
have classified the proceeds £815k (2019: nil) 
as Grant Income. The UK furlough scheme 
also provided support for the Group during 
COVID-19, which amounted to £40k in Grant 
Income.

34

Exceptional items
Restructuring costs for the year totalled 
£353K (2019: £21K) with £252k relating to the 
reduction in staff and consultants in the 
Central segment were charged in the year.

Restructuring costs of £101k due to the 
reduction in staff and consultants were 
charged to the Cardiac & Other segment in 
2020.

Exceptional items includes a £6,130k non-cash 
impairment charge arising from the annual 
impairment test on the CellRight Technologies 
cash generating unit. The uncertainty created 
by the COVID-19 pandemic necessarily resulted 
in more conservative forecasting of future cash 
flows which in turn gave rise to the reported 
impairment. Further details on the impairment 
test can be found in note 12.

Cost of sales and gross profit
Gross profit for the year is £5,896k (2019: 
£6,019k). Gross margin percentage remained 
the same at 46% (2019: 46%).

Included in costs of sales is cost of product 
£5,990k (2019: £5,803k) and third party 
commissions of £943k (2019: £1,211k).

Administrative expenses
During 2020, administrative expenses 
before exceptional items decreased by 
£3,132k to £10,066k (2019: £13,198k), largely 
due to a reduction of £2,600k in spending 
at the Central overhead function to £1,325k 
(2019: £3,925k). This reduction was driven by 
the downsizing in Q4 2019 which resulted 
in 18 positions being made redundant in 
addition to £736k reduced depreciation and 
amortisation after the impairment recorded 
in 2019. In addition, certain expenses related 
to ongoing clinical trials of OrthoPure® XT 
(£215k) are now capitalised due to the recently 
received CE Mark. Historically these expenses 
were expensed as incurred, but accounting 
standards require these to be capitalised 
once relevant conditions have been met. 
Administrative expenses at the BioSurgery 
division decreased £1,069k to £2,660k (2019: 
£3,729k) due primarily to reduced staffing 
levels which decreased £756k to £2,106k (2019: 
£2,862k).

Finance income/charges
Finance income of £2k (2019: £17k) represented 
interest earned on cash deposits. Finance 
charges for the year were reported at £445k 
(2019: £477k) and related to interest charges 
and associated costs for the MidCap loan 
arrangement of £245k (2019: £384k) in addition 
to interest arising due to the adoption of IFRS16 
of £200k (2019: nil).

TISSUE REGENIX GROUP PLCANNUAL REPORT AND ACCOUNTS FOR THE YEAR ENDED 31 DECEMBER 2020  
Taxation
The Group continues to invest in developing 
its product offering, and as such, is eligible to 
submit enhanced research and development 
tax claims in the UK, enabling it to exchange 
tax losses for a cash refund. In the year to 
December 2020, a refund of £440k was 
receivable (2019: £488k). The year-on-year 
reduction was a result of the business 
continuing to move its resources away 
from research and development to more 
commercial activities.

Gross tax losses carried forward in the UK were 
£51,104k (2019: £43,533k). The Group does not 
currently pay tax in the UK. A deferred tax 
asset has not been recognised as the timing 
and recoverability of the tax losses remain 
uncertain. Corporation tax payable in the US 
amounted to £0k (2019: £29k).

Loss for the year
The loss for the year was £9,708k (2019 loss: 
£7,106k) resulting in a basic loss per share of 
(0.22p) (2019 loss per share: 0.60p). 

Balance sheet
At December 2020, the Group had net assets of 
£27,847k (2019: £24,595k) of which cash in hand 
totalled £9,550k (2019: £2,380k).

Inventory increased by £2,887k to £7,072k 
(2019: £4,185k) as the BioSurgery and 
Orthopaedics & Dental segments added to 
stock levels to support projected business 
growth.

Property, plant and equipment increased by 
£895k to £3,252k (2019: £2,357k) related to the 
expansion of the US manufacturing facility.

A Right of Use asset was recorded in 2020 of 
£2,458k in accordance with IFRS 16, Leasing 
(2019: nil). The Group took on property leases in 
the US and UK, resulting in a Right of Use Asset 
and a related Lease liability on the balance 
sheet.

Intangible assets decreased to £10,931k (2019: 
£17,999k) through amortisation charges in 
the year and the non-cash charge against 
Goodwill of £6,130k (2019: nil). A further £215k of 
development costs were capitalised in the year.

Working capital increased in the year to 
£7,277k (2019: £4,644k) driven by increased 
inventory (£2,887k increase). The balance sheet 
included corporation tax receivable of £825k 
(2019: £1,035k) in respect of UK research and 
development tax credits. 

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STRATEGIC REPORTI

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Borrowings
Non-current liabilities represent the £2,790k 
debt facility. This includes £1,473k of the 
term loan and £1,507k of the revolving credit 
facility, net of £190k of capitalised debt issue 
costs. The debt facilities mature in 2024 with 
quarterly principal repayments on the term 
loan of $500k per quarter starting in July 2023. 
The Group is in compliance with the financial 
covenants related to the debt facilities as of the 
date of this report.

 More information on these obligations is 
provided on page 91.

Dividend
No dividend has been proposed for the year to 
31 December 2020 (2019: Nil).

Accounting policies
Following the departure from the EU, the 
Group’s consolidated financial information 
has been prepared in accordance with 
International Accounting Standards in 
conformity with the UK Companies Act 2006.
The Group’s significant accounting policies, 
which have been applied consistently 
throughout the year, are set out on pages 73 
to 77.

Going concern
The Group financial statements have been 
prepared on a going concern basis based on 
cash flow projections approved by the Board 
for the Group for the period to 31 December 
2022 (the “Cash Flow Projections”). 

Funding requirements are reviewed on a 
regular basis by the Group’s Chief Executive 
Officer and Chief Financial Officer and are 
reported to the Board at each Board meeting, 
as well as on an ad hoc basis, if requested. The 
Cash Flow Projections show that the Group will 
continue to consume cash over the forecast 
period. Until sufficient cash is generated from 
its operations, the Group remains reliant on 
cash reserves of £9.6m at 31 December 2020 
and the ongoing support of MidCap Financial 
Trust (“MidCap”)(borrowings of £2.8m at 31 
December 2020) to meet its working capital 
requirements, capital investment programme 
and other financial commitments. 

The COVID-19 pandemic has affected most 
businesses during 2020. As a result of the 
reprioritisation of healthcare professionals 
during this time, there has been a decline 
in elective procedures undertaken across a 
number of medical specialities that use our 
products. Given the uncertainty around the 
level and duration of disruption from COVID-19, 
it is difficult to determine how long the current 
situation may last, and the time taken to 
catch-up any postponed surgical procedures 
thereafter. 

However, the Board, in compiling the Cash 
Flow Projections, has considered a downside 
scenario regarding the effect of reduced and 
delayed revenues due to COVID-19 and, has 
undertaken market soundings regarding the 
likely timeframe for the recommencement 
of procedures. It has concluded that there 
will not be a significant long-lasting impact 
on the capability of the business to carry 

36

TISSUE REGENIX GROUP PLCANNUAL REPORT AND ACCOUNTS FOR THE YEAR ENDED 31 DECEMBER 2020  
out its commercial activities. The Cash Flow 
Projections prepared by the board, including 
the downside scenario, indicate that the Group 
will still have cash reserves at the end of the 
forecast period.

The Group’s Cash Flow Projections also 
assume that the MidCap facilities are available 
throughout the forecast period as they are 
repayable in 2024. The availability of these 
facilities is dependent upon compliance with a 
rolling twelve month revenue covenant which 
is measured on a monthly basis. The Cash 
Flow Projections indicate compliance with this 
covenant throughout the forecast period. The 
scenario reflecting very low growth indicates 
that this covenant may be breached in the 
second half of 2022. That scenario also shows 
that the MidCap facility could be repaid from 
cash reserves in the event that repayment was 
demanded by MidCap.

In summary, the Directors have considered 
their obligations in relation to the assessment 
of the going concern basis for preparation of 
the financial statements of the Group and 
have reviewed the Cash Flow Projections. 
On the basis of their assessment, they have 
concluded that the going concern basis 
remains appropriate for use in these financial 
statements.

Post balance sheet events
The Group has remained committed to 
appropriately sizing its overhead cost base 
and expenditure. To this end, further re-
structuring of the US business was undertaken 
in January 2021 to rationalise resources 

across the business which is expected to 
reduce the overhead cost base by c. $700k 
on a normalised, annualised basis. With 
respect to the COVID-19 pandemic, there is 
beginning to be a slight development in the 
recommencement of surgical procedures 
in the United States as the vaccine roll-out 
continues and patient confidence returns, 
however, it remains difficult to predict at what 
pace a return to pre-pandemic procedural 
levels will occur.

Principal risks & uncertainties
The principal risks and uncertainties facing the 
Group are set out on pages 38 to 43.

Cautionary statement
The strategic report, containing the strategic 
and financial reports of the Group contain 
forward-looking statements that are subject 
to risk factors associated with, amongst other 
things, economic and business circumstances 
occurring from time to time within the 
markets in which the Group operates. 
The expectations expressed within these 
statements are believed to be reasonable but 
could be affected by a wide variety of variables 
beyond the Group’s control. These variables 
could cause the results to differ materially 
from current expectations. The forward-
looking statements reflect the knowledge 
and information available at the time of 
preparation. 

David Cocke  
Chief Financial Officer

27 April 2021

37

STRATEGIC REPORTTISSUE REGENIX GROUP PLC

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Our risk management framework
Accountability for reviewing and monitoring

The Board
The Board is responsible for  
maintaining a sound system of internal  
control. The Board implements measures  
that are designed to manage, not eliminate,  
risk, and such a system provides reasonable,  
but not absolute, assurance against  
material misstatement or loss. The Board 
confirms that it has established the  
procedures necessary to implement the 
guidance under  
the QCA Corporate  
Governance Code.

Operational
At an operational level, we monitor  
monthly performance against objectives  
allowing us to track performance and 
 identify any potential improvements to our 
structure and operational efficiencies, as  
well as monitoring and updating 
any existing or potential risks and 
corresponding mitigating actions. 

Responsibility  
for implementation
The Board reviews and updates risks on a regular  
basis, maintains a risk register and addresses each  
potential risk in terms of likelihood and impact on the  
business. In accordance with our governance practices, the  
Audit Committee supports the Board of Directors in  
monitoring the Group’s risks.

We have identified six areas of potential risk: Finance & IT, 
Operational, Clinical & Regulatory, Commercial, HR and the wider 
political and social environments. The Board believes the following 
risks are the most significant for the Group, however, they  
may not necessarily comprise all the associated or potential risks 
attached to the Group. Alongside risks associated with  
changes in the market or economic conditions, the political 
landscape, legal, regulatory or tax implications, there may  
also be risks that the Directors are currently unaware of but  
that could have a significant effect on the Group’s ability  
to carry out its business. 

A list of the principal risks and  
mitigating factors facing the Group at this  
time are listed below. 

38

ANNUAL REPOR T AND ACC OUNTS FOR THE YEAR ENDED 31 DEC EMBER 2020

Risk

Potential impact

Mitigating factors

Trend

 Finance and IT

Risk that there 
are insufficient 
funds to deliver 
products to the 
market, invest in 
required expansion 
or provide the 
working capital 
required 

We require investment into 
our infrastructure to bring 
our product portfolios to 
market and service the 
increasing demand from 
our current and future 
customers. Without this, 
the Group will be unable 
to deliver the anticipated 
future revenue growth.

Risk that there is 
a lack of financial 
contingencies 
or adverse 
performance leads 
to a lack of liquidity 

Risk that the Group 
will be subject to 
a cyber security 
breach, failure 
of IT systems, or 
a catastrophic 
failure resulting in 
a significant data 
loss 

Should there be a lack of 
financial contingencies 
in place, the Group could 
be affected by limited 
cash resources to support 
the working capital and 
investment requirements. 
Similarly, should the Group 
have an adverse financial 
performance, this would 
impact the financial 
resources of the Company 
and its ability to reach 
profitability. 

The Company is reliant 
upon systems to allow for, 
amongst other things, 
the accurate records and 
reporting of donors. Any 
potential failure of systems 
could impact the Group’s 
ability to process and 
distribute products, lead 
to a data security breach, 
loss of financial information 
and have potential financial 
implications. 

The equity fundraise in June 2020 provides 
both investment and working capital 
required by the Group for the foreseeable 
future however, the ongoing impact of 
COVID-19 on the healthcare markets may 
alter the investment or working capital 
deployment timetables.

The Board has oversight of all significant 
cash spends and a well-established 
control environment, which includes 
internal forecasting, monthly reporting 
and approval limits on all purchase orders. 

In order to maintain the cash position, 
the Company reviews business priorities 
and demands to ensure that funds are 
invested in the most appropriate manner 
to deliver a return on investment and 
grow the business. 

Alongside the recent fundraise which 
provides the Group with the opportunity 
to grow both its operational and 
commercial opportunities significantly, 
a robust overhead cost reduction 
programme was also undertaken during 
2020. It is expected that this will continue 
during 2021 and in conjunction with the 
capacity expansion programme and 
development of strategic partnerships 
and other customers, will drive the Groups 
performance and ensure a suitable level of 
financial contingency remains. 

The Group was subject to a cyber security 
incident in January 2020. No ongoing 
material impact to the business was 
experienced, however, processing and 
production was temporarily halted at the 
San Antonio facility while the restoration 
and testing of systems was completed. 
The Group has since reviewed its IT service 
providers and implemented additional 
security procedures and continues to do 
so on an ongoing basis moving forward. 
The Group has an established disaster 
recovery plan and ensures that secure 
back ups are held off-site in case of any 
potential breach. 

Key

 Increasing 

 Decreasing 

 No change

39

STRATEGIC REPORTD
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Risk

Potential impact

Mitigating factors

Trend

 Operational

Risk that the Group 
may experience 
an adverse event 
resulting in a loss 
of license or facility 
shutdown e.g. 
damage due to fire, 
arson, flood or other 
adverse events, or 
retraction of licence 
from the FDA, 
AATB, HTA or other 
regulatory body 

As the Group manufactures 
most products in-house the 
loss of a manufacturing facility 
would have a detrimental 
effect on the ability to meet 
customer demand. Should an 
adverse event happen there 
would be a loss of stock and 
raw materials, which would 
have significant financial 
implications. 

The Group has a track record of positive 
feedback following audits and inspections 
and has established control environments 
and procedures. Facility insurance is in place 
in case of adverse events and second source 
manufacturing options have been identified. 
Once the new facility in San Antonio is 
fully operational, this will offer a separate 
manufacturing facility which will further 
reduce the risk.

COVID-19 provided a real-time test however, 
by implementing initiatives operations at 
the facility in San Antonio were successfully 
maintained throughout the course of the 
pandemic. 

Following the relocation of the UK facility in 
October 2020, it was successfully audited and 
accredited by the regulatory authorities in Q1 
2021.

Risk of over 
dependency on 
single supplier 
including failure to 
secure sufficient 
tissue, or in-house 
processing

Risk that products 
supplied by sub-
contractor is of 
inferior quality 

Risk that the 
business is unable to 
expand in line with 
growing demand 

With the novel technology 
processes requiring specific 
raw materials, the loss 
of a supplier could have 
a detrimental effect on 
the ability to produce the 
media required for the 
decellularisation techniques. As 
the products are based around 
animal or human tissues, 
failure to source good quality, 
ethically handled tissues 
would result in the inability to 
produce products in line with 
specifications and therefore 
incur reputational damage, 
customer dissatisfaction and 
potential regulatory breaches. 

Business interruption insurance is in place 
and alternative suppliers are identified to 
ensure that there is always a secondary 
source for raw materials. We have an 
experienced donor recovery manager who 
has expanded the number of donor services 
agencies that we work with in the US, 
whilst in the UK we have two suppliers for 
the required porcine tissues. All suppliers 
are comprehensively qualified to meet the 
Company’s internal standards and those 
imposed by third party moderators. A 
percentage of our DermaPure® processing 
is outsourced to a processing partner CTS 
and as above, once the new facility in San 
Antonio is fully operational, this will offer a 
separate manufacturing facility reducing 
the dependence on one facility in-house 
processing. 

Due to the capacity constraints 
that have historically impinged 
the growth of the Company, 
additional manufacturing 
resources were secured via 
a third party. If the product 
supplied by this partner is 
of inferior quality to that 
processed in-house there is the 
risk of reputational damage 
and financial losses to the 
Company. 

Regular audits are undertaken at key 
suppliers and sub-contractors and all 
suppliers and sub-contractors are subjected 
to a qualification process. In addition raw 
materials are inspected prior to use to 
ensure they conform to specifications. We 
also undertake regular quality checks of the 
finished products and commit sufficient time 
to training and supporting the processing 
teams to ensure that processing techniques 
are standardised and technicians are fully 
trained. 

Our commercial strategy is 
built around the establishment 
of successful strategic and 
distribution partnerships, 
which increase the demand 
on our production and 
manufacturing capabilities. 
If we are unable to expand 
in line with this demand 
this could result in a loss of 
business through customer 
dissatisfaction and reputational 
damage. 

The Group identified capacity constraints 
as an issue and took steps such as 
initiating a second shift and outsourcing a 
percentage of the DermaPure® processing 
to initially alleviate these constraints. 
Following the fundraise in June 2020, the 
Group commenced a capacity expansion 
programme in the US which should come 
onstream during H1 2021 and provide a c.50% 
uplift on the current BioRinse® processing 
levels. The capacity expansion programme 
has been split into phases with the 
additional uplift provided by phase two yet to 
commence. 

TISSUE REGENIX GROUP PLCANNUAL REPORT AND ACCOUNTS FOR THE YEAR ENDED 31 DECEMBER 2020Risk

Potential impact

Mitigating factors

Trend

 Clinical and regulatory 

Risk that products 
fail and cause 
death or injury on 
implantation into 
patients 

Should a product fail upon 
implantation or incur an 
adverse reaction due to 
the product properties, the 
Group would be at risk of 
legal action, potential loss of 
earnings through product 
retraction from the market 
and reputational damage. 

Risk of loss 
of license or 
restrictions due to 
regulatory failings 

As the Group operates in a 
highly regulated environment 
the loss of a license to 
manufacture or sell products 
within a territory would result 
in reputational and financial 
damage to the Company.

Before commercialisation, a series 
of clinical and safety checks are run 
dependent on the nature of the 
product. For our porcine products 
that require a full clinical trial, this 
will initially be within an animal 
model to confirm its safety before 
progressing to the regulated clinical 
trial to judge the performance of 
the product. An external regulatory 
body review is undertaken and 
once market clearance is gained, 
comprehensive training is provided 
for sales representatives and 
surgeons prior to utilisation of the 
product. For our human tissue 
products, qualification and validation 
studies are commenced prior to 
commercialisation and all products 
are issued with detailed instructions 
for use. 

The Group employs regulatory 
experts for each territory in which 
manufacturing takes place, or 
where the Group looks to navigate a 
regulatory clearance for a product. 
The Group also has a track record of 
positive feedback following external 
audits and inspections and operates 
in established control environments. 

Key

 Increasing 

 Decreasing 

 No change

41

STRATEGIC REPORTRisk

Potential impact

Mitigating factors

Trend

 Commercial

Risk that a 
competitor 
product reaches 
the market first 
and/or products 
outperform Tissue 
Regenix products, 
and the business 
fails to keep up 
with developments 
and new products 
coming to the 
market

Risk of 
overdependence 
on a single 
customer, the loss 
of which would be 
significant 

 HR

Risk of potential 
loss of key staff 
resulting in a loss 
of key information, 
contacts or know-
how, or skills 
shortages which 
may lead to over-
reliance on key 
individuals 

Should there be a competitive 
product that outperforms one 
of the Tissue Regenix products 
we could lose customers and 
distribution opportunities. 
Should a competitor bring a 
product to market before us 
they could potentially have an 
advantage in gaining market 
share. 

We continually monitor the commercial 
and competitive landscape and look to stay 
ahead of the trend with innovative product 
development and line extensions. The Group 
works with partners to identify potential 
market opportunities. The Group also 
continues to collect post marketing clinical 
data to ensure that the product offering 
remains differentiated. 

The Group has a number of key 
customer’s however, should 
the Group be overdependent 
on a single customer and 
not maintain a diversified 
customer base, the Group 
could become exposed if 
that customer reduced their 
ordering pattern or move 
their business elsewhere. In 
this case, the Group could 
be subject to material losses 
in terms of revenue and 
also experience a backlog 
of inventory that had been 
processed in line with 
expectations. 

The dCELL® process is patent 
protected, however, the 
BioRinse® process is based on 
know-how and the Company 
has several trade secrets 
that it looks to protect. As 
our commercial pipeline is 
based upon key strategic and 
distribution partnerships, as 
well as direct sales, there is the 
potential that customers may 
feel a loyalty to a person rather 
than the brand. The industry 
that we operate in is highly 
skilled and it is important that 
we can continue to attract 
and retain the highly skilled 
individuals required. 

The Group is augmenting its product portfolio 
with additional product line extensions and 
product launches, which diversify the clinical 
applications and customer base. During 2020, 
the Group signed a white label manufacturing 
agreement with a significant distribution 
partner as well as securing a number of 
additional customers for smaller products 
lines. Furthermore, following the launch of 
OrthoPure® XT, the Group has extended its 
distribution network into the EU.

The Remuneration Committee is in place to 
ensure that salaries and incentive schemes 
are benchmarked against industry standards 
and reviewed on an annual basis.

Contracts of employment are drafted to 
include the necessary confidentiality and 
non-compete clauses. Any potential skill 
shortages in our employee base are identified 
and we continuously monitor the market 
to ensure that suitable individuals can be 
recruited. Internally, we look to ensure that 
succession planning is implemented to 
minimise the potential impact should any 
senior level roles choose to exit the business. 

D
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42

TISSUE REGENIX GROUP PLCANNUAL REPORT AND ACCOUNTS FOR THE YEAR ENDED 31 DECEMBER 2020Risk

Potential impact

Mitigating factors

Trend

 Political and economic landscape 

Risk of significant 
change in political 
or economic 
landscape

The UK and the US have both 
experienced recent periods of 
political uncertainty, primarily 
due to Brexit negotiations, 
Presidential Elections and 
COVID-19. There is the potential 
that this could affect our ability to 
commercialise and import/export 
our products. 

We have applied for and maintain 
the relevant licenses necessary 
for import/export of our products, 
including HTA and FDA approvals.

We have worked closely with the 
notified and regulatory bodies in 
the UK and Europe to ensure that 
we hold the required certification 
to continue commercialisation with 
the EU following the Brexit transition 
period. 

 Social and environmental

Risk of unexpected 
social or 
environmental 
event that could 
affect the Group’s 
ability to process or 
commercialise its 
product portfolio

As seen with the COVID-19 
pandemic in 2020, there may 
be events that are outside of 
the control of the Group that 
have social or environmental 
impacts on the ability of the 
Group to continue to process its 
products due to, amongst other 
things, lack of suitable donor 
materials, personal protective 
equipment for staff or inability 
of staff to attend the workplace. 
Such events may also have an 
impact on the level of applicable 
procedures being undertaken 
by healthcare professionals and 
therefore impact the Group’s 
revenue expectations.

The Group ensures to maintain 
sufficient stock of all required 
personal protective equipment and 
donor materials to allow for the 
continuation of processing should 
supply of these items become 
temporarily compromised. Due to 
the nature of the processing and 
facilities, hygiene and cleanliness 
is always of the highest priority. 
During the COVID-19 pandemic, 
processing continued at the facility 
in San Antonio with a transition to 
work from home for certain staff and 
staggered shift patterns to minimise 
the number of employees on site 
at once with individual working in 
the clean rooms ensuring that we 
continue to have product supply to 
meet the expected demand. 

Key

 Increasing 

 Decreasing 

 No change

43

STRATEGIC REPORTTISSUE REGENIX GROUP PLC

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Corporate
The Group recognises that it holds a corporate 
responsibility to its employees, customers, 
partners, suppliers and shareholders. To this 
end, the Group ensures to set and maintain 
the highest employment, ethical and 
management standards. 

The Group follows the QCA Corporate 
Governance Code and relies on its experienced 
management team and Board of Directors to 
ensure that all regulatory requirements across 
all business functions are met. 

Ethics and compliance 
Operating in an industry based upon the 
processing of donated human or animal 
tissues demands the highest ethical standards 
throughout every facet of the Group. The 
Group aspires to implement and maintain 
these standards across all business functions 
and relations. The Group undertakes regular 
audits of partners, suppliers and employees 
to ensure that they comply with the 
ethical standards and operate to meet our 
expectations. Furthermore, the nature of the 
industry means that, as a business we are held 
to the highest standards by regulatory bodies, 
and likewise receive audits and inspections 
from external organisations such as the US 
Food and Drug Administration, Human Tissue 
Authority and American Association of Tissue 
Banks. The Group has a positive track record 
of passing all regulatory inspections and 
where recommendations are made to improve 
the control environment, the Group looks 
to implement where applicable, as soon as 
practically possible. 

Modern slavery statement 
The Group is committed to respecting human 
rights across all its operations and aims to 
work at the highest international standards 
in addition to local requirements. The Group 
fully supports the Modern Slavery Act 2015 
and seeks to ensure the Group’s activities and 
those in its supply chains do not infringe on, or 
encourage, human rights abuses. 

Anti-corruption and  
anti-bribery matters
Group policies are in place for topics such 
as anti-bribery and anti-corruption. These 
policies are regularly reviewed by the Executive 
management team and HR departments, 
copies of policies are provided to all employees 
during their induction and changes or updates 
are communicated to staff accordingly. 

Employees
At the core of our business is our talented 
employee base, which drives the success of 
the Group. Through our values and behaviours, 
we look to develop a working environment 
in which employees are supported, continue 
to develop and can perform to the best of 
their abilities. We encourage teamwork 
and openness in the workplace, through 
Company-wide policies and procedures, and by 
addressing the individual needs of employees 
to provide a functional working environment 
that enables a healthy work/life balance.

Equal opportunities
The Group is committed to ensuring that 
equal opportunities are provided to all 
employees and potential employees, and do 
not discriminate on the basis of age, gender, 
ethnicity, religion, disability, sexual orientation 
or marital status. All employees are expected to 
conduct themselves in an appropriate manner 
adhering to our non-discrimination policy. 

In all aspects of our business the Group looks 
to act in ways that are compliant with the 
necessary laws and regulations, providing our 
employees with a work environment that is 
professional, ethical and fair. 

Environmental sustainability
As with all businesses the emphasis on 
environmental sustainability is of the utmost 
importance and is subject to increasing 
scrutiny and regulation. It is the responsibility 
of all employees to follow the initiatives 
implemented to decrease our carbon footprint, 
energy consumption and environmental 
sustainability efforts.

During 2020, the Group continued to 
implement environmental sustainability 
initiatives: 

 ▶ Continued to upgrade to LED lighting 

alternatives in our offices, clean rooms and 
sterile packaging areas

 ▶ Switched to plastic bins rather than 

cardboard boxes in our WIP storage area 
which will reduce our cardboard waste

 ▶ Replacement of our air compressor and 

drying unit with a smaller, more efficient 
unit which is expected to reduce this energy 
consumption by c.70% 

 ▶ In our facility expansion, the design included 

energy saving LED lighting with self-
dimming or motion sensors throughout 
the facility, higher efficiency heating and 
cooling units, and greater use of solid 
flooring versus carpeting. Regarding 
equipment, we will be implementing high 
efficiency ultra-low temperature freezers 
which use natural refrigerants

44

ANNUAL REPOR T AND ACC OUNTS FOR THE YEAR ENDED 31 DEC EMBER 2020

Corporate social 
responsibilities (“CSR”)
Operating in a highly regulated environment, 
with particular sensitivities and responsibilities 
around human donor processing, the Group 
ensures to operate with a high level of CSR 
across the business every day. Through the 
gift of tissue donation we have the ability 
to positively impact hundreds of patients’ 
lives, therefore, we must treat each gift with 
the utmost respect and provide the next 
of kin with information around how many 
patients the donation has helped, if requested; 
something that can often help in the grieving 
process.

Health and safety 
We see the development and maintenance 
of a robust health and safety framework as a 
necessity in order to protect our employees, 
customers, suppliers and external stakeholders. 
The Board reviews a health and safety report 
as part of the monthly Board pack, which 
contains information on any near miss 
events, accidents, incidents and preventative 
measures implemented. During 2020, no 
serious adverse events were experienced. 

Improved patient care and 
health economic outcomes 
Tissue Regenix technology platforms dCELL® 
and BioRinse®, process products that can 
enable improvements in patient care, 
enhancing or restoring their quality of life, 
which can often be transformative. 

On top of this, it allows for economic 
advantages in the cost of care by reducing the 
hospital stay or additional treatments, better 
clinical outcomes and minimised rehabilitation 
- in some orthopaedic cases - a reduction 
in reoccurring operations, and in many 
circumstances, a reduction in associated pain. 

Engagement and 
communication 
The Group endeavours to undertake 
engagement and communications with 
all stakeholder groups whether they are 
employees, investors, partners, suppliers, 
customers, donor families or key opinion 
leaders, and considers how the day-to-day 
activities of the Group, and the principal 
decisions taken throughout the year, could 
affect each stakeholder group. 

The Group has an established vision, mission, 
values and behaviours that form an integral 
part of the Tissue Regenix Group ethos and 
culture. 

During 2020, the Group also looked to improve 
its communication and engagement with 
retail investors by allowing participation in the 
equity fundraise through a PrimaryBid offering 
and undertaking Company presentations 
through the investor meet platform. 

Values and behaviours
Our values and behaviours align with our vision 
and mission, driving a culture that will enable 
the Group to achieve our strategic objectives 
and KPIs.

 Dedication to patients 

Our patients are at the heart of 
everything we do, and we are 
committed to delivering life-changing 
solutions

 Passion for innovation 

We harness creativity across all areas 
of our business to generate novel and 
effective solutions

 Uncompromising integrity 

We take pride in what we do and are 
committed to the highest standards of 
ethics, honesty and fairness to earn the 
respect of all our stakeholders

 Driving for excellence

We continually seek excellence by 
delivering against our objectives and 
holding each other to account to 
perform to the best of our ability

Vision and mission

Physicians

We will partner with 
physicians to provide 
trusted solutions that 
deliver superior clinical and 
health economic outcomes 
utilising our core technology 
platforms for both  
allograft and xenograft  
tissue.

Customer

We will deliver 
to our customers via 
unparalleled service, 
innovative solutions that 
challenge the existing market 
place assumptions on 
clinical efficacy and value 
and maximise the gift 
of allograft tissue 
donation.

Patient

Mission
Restoring 
 patient  
function and 
vitality

Employees

We will foster a vibrant 
and diverse culture that 
rewards performance and 
accountability, nurturing 
career development.

Shareholders

We will deliver market 
performances that make 
Tissue Regenix a focus 
of strategic investment 
for investors, providing 
sustained and predictable 
growth with above  
category returns.

45

STRATEGIC REPORTindividually and together, that they have acted in the way they 
consider, in good faith, would be most likely to promote the 
success of the Company for the benefit of its members as a 
whole (having regard to the stakeholders and matters set out 
in s.172(1)(a-f) of the Act) in the decisions taken during the year 
ended 31 December 2020.

T The Directors of Tissue Regenix Group plc consider, both 
N
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S

Stakeholder 
group

Why?

How?

What were the key topics of engagement and consideration in principal decisions, 2020

Investors

Employees

We strive to engage with our investor base 
and obtain investor buy-in and confidence 
in our commercial strategy and strategic 
objectives, which is discussed in more 
detail on pages 16 to 19.

A supportive base of investors interested in 
a long-term holding in the Group provides 
the stability required to allow us to execute 
the agreed strategy and deliver improved 
financial results. 

The Board is fully committed to having 
open and transparent dialogues with 
all shareholders. Throughout the year, 
management and Directors look to meet 
with, and update, institutional and retail 
investors through a variety of platforms; 
whether it be by face-to-face meeting, 
telephone conversation, AGM, retail 
investor forum or presentation, website or 
social media, or news announcements. 

Throughout the year management hold 
a number of town hall meetings where 
employees are fully briefed on Company 
developments and have an open forum to 
ask questions. 

Email updates are also issued as Company 
news is announced to ensure that 
all employees are aware of the latest 
developments. 

Team meetings are encouraged at least 
once a week, with line managers then 
reporting directly into the CEO every week 
to ensure cohesion across the business. 
This also allows any concerns from 
employees to be raised with line managers 
and escalated to the Executive team in a 
timely manner if required. 

The long-term success of the Company 
is built around our highly skilled and 
experienced workforce. 

Our technicians are highly specialised, 
and we have world class processing and 
development expertise at all facilities. We 
continue to expand our network of partner 
and distributor relationships who are 
managed by our experienced commercial 
teams. 

We look to create an environment where 
all employees can excel and value both 
practical experience as well as academic 
qualifications. We believe in investing in 
our workforce to maintain a low turn-
over rate and build an agile and adaptive 
workforce who can successfully navigate 
the ever-evolving industry landscape to 
maintain our competitive positioning. We 
support employees with further education 
and qualifications, in-house support for 
the development of managerial roles 
and provide a remuneration and benefits 
framework that supports a healthy work/
life balance and is competitive with 
industry standards. 

Key topics of engagement for investors throughout the year was around: 

The equity fundraise and financing and investment required for the future of the business.

The changes to the Executive management team.

Changes to the Non-Executive Directors.

The response and implications of the COVID-19 pandemic. 

Full year and interim financial results and reports.

Consideration in principal decisions: 

The Board consulted with shareholders regarding the future funding of the Group and provided frequent 

updates to the market around the cash runway and requirements of the Group. The Board also ensured that 

shareholders were aware of the capacity expansion project, the investment that this would require and the 

potential shareholder value created. During the year there was also a number of changes to the Executive 

management and Board composition, the Board considered the skill set and experience required to lead 

the business successfully through the next stages of commercialisation and achieve the long term Group 

strategy and employed changes accordingly to achieve the best results. 

Key topics of engagement for employees throughout the year was around: 

The change of Executive management as Daniel Lee was appointed to the position of CEO. 

The financial position of the Group and the requirement for future funding. 

The response to the COVID-19 pandemic and the decision to furlough UK members of staff. 

The commencement of the capacity expansion project in San Antonio. 

The relocation of the UK facility from Swillington, Leeds to Garforth, Leeds. 

Health and safety protocols and procedures. 

Updates to quality management systems and training records. 

Consideration in principal decisions: 

The most significant decision affecting our employees during 2020 was the Group’s response to the COVID-19 

pandemic. In the UK the decision was made to furlough operations and technical employees during the 

first UK lockdown, all employees were re-engaged in July and have successfully been retained throughout 

subsequent lockdowns. In the US, we maintained operations throughout and implemented additional 

operating procedures to ensure that employees were properly safeguarded from any potential risks. 

Alongside this, as part of the overhead cost reduction initiatives the decision was made to relocate the UK 

facility. In order to retain our skilled workforce, it was important that any move remain within a commutable 

distance from the facility in Swillington. The move to nearby Garforth was undertaken in October 2020 and 

as part of this, elements of the production cycle were outsourced to allow for the downsizing which had to be 

carefully managed to ensure no future impact on the business. 

The changes to the Executive management team were carefully communicated to the employees to ensure 

that all were comfortable with the change from a UK based CEO to US however, as Danny Lee had been a 

part of the senior management team for a period of time, this change was widely accepted. 

2
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TISSUE REGENIX GROUP PLCANNUAL REPORT AND ACCOUNTS FOR THE YEAR ENDED 31 DECEMBER 2020 
  
Section 172 of the UK’s Companies Act 
describes a company director’s general duty 
to promote the success of the company: A 
director of a company must act in the way 
they consider, in good faith, would be most 
likely to promote the success of the company 
for the benefit of its members as a whole, 
and in doing so have regard (amongst other 
matters) to: the likely consequences of any 
decisions in the long term; the interests of 
the company’s employees; the need to foster 
the company’s business relationships with 

suppliers, customers and others; the impact of 
the company’s operations on the community 
and the environment; the desirability of the 
company maintaining a reputation for high 
standards of business conduct; and the need to 
act fairly as between members of the company. 

Overview of how the Board  performed its 
duty to promote the success of the Group 
The following table summarises how the Board 
has met the s172 obligations throughout the 
year for the various stakeholder groups. 

How?

What were the key topics of engagement and consideration in principal decisions, 2020

Key topics of engagement for investors throughout the year was around: 
The equity fundraise and financing and investment required for the future of the business.
The changes to the Executive management team.
Changes to the Non-Executive Directors.
The response and implications of the COVID-19 pandemic. 
Full year and interim financial results and reports.

Consideration in principal decisions: 
The Board consulted with shareholders regarding the future funding of the Group and provided frequent 
updates to the market around the cash runway and requirements of the Group. The Board also ensured that 
shareholders were aware of the capacity expansion project, the investment that this would require and the 
potential shareholder value created. During the year there was also a number of changes to the Executive 
management and Board composition, the Board considered the skill set and experience required to lead 
the business successfully through the next stages of commercialisation and achieve the long term Group 
strategy and employed changes accordingly to achieve the best results. 

Key topics of engagement for employees throughout the year was around: 
The change of Executive management as Daniel Lee was appointed to the position of CEO. 
The financial position of the Group and the requirement for future funding. 
The response to the COVID-19 pandemic and the decision to furlough UK members of staff. 
The commencement of the capacity expansion project in San Antonio. 
The relocation of the UK facility from Swillington, Leeds to Garforth, Leeds. 
Health and safety protocols and procedures. 
Updates to quality management systems and training records. 

Consideration in principal decisions: 
The most significant decision affecting our employees during 2020 was the Group’s response to the COVID-19 
pandemic. In the UK the decision was made to furlough operations and technical employees during the 
first UK lockdown, all employees were re-engaged in July and have successfully been retained throughout 
subsequent lockdowns. In the US, we maintained operations throughout and implemented additional 
operating procedures to ensure that employees were properly safeguarded from any potential risks. 

Alongside this, as part of the overhead cost reduction initiatives the decision was made to relocate the UK 
facility. In order to retain our skilled workforce, it was important that any move remain within a commutable 
distance from the facility in Swillington. The move to nearby Garforth was undertaken in October 2020 and 
as part of this, elements of the production cycle were outsourced to allow for the downsizing which had to be 
carefully managed to ensure no future impact on the business. 

The changes to the Executive management team were carefully communicated to the employees to ensure 
that all were comfortable with the change from a UK based CEO to US however, as Danny Lee had been a 
part of the senior management team for a period of time, this change was widely accepted. 

Stakeholder 

group

Why?

Investors

We strive to engage with our investor base 

The Board is fully committed to having 

and obtain investor buy-in and confidence 

open and transparent dialogues with 

in our commercial strategy and strategic 

all shareholders. Throughout the year, 

objectives, which is discussed in more 

management and Directors look to meet 

detail on pages 16 to 19.

A supportive base of investors interested in 

a long-term holding in the Group provides 

the stability required to allow us to execute 

the agreed strategy and deliver improved 

financial results. 

with, and update, institutional and retail 

investors through a variety of platforms; 

whether it be by face-to-face meeting, 

telephone conversation, AGM, retail 

investor forum or presentation, website or 

social media, or news announcements. 

Employees

The long-term success of the Company 

Throughout the year management hold 

is built around our highly skilled and 

a number of town hall meetings where 

experienced workforce. 

employees are fully briefed on Company 

developments and have an open forum to 

Our technicians are highly specialised, 

and we have world class processing and 

ask questions. 

development expertise at all facilities. We 

Email updates are also issued as Company 

continue to expand our network of partner 

news is announced to ensure that 

and distributor relationships who are 

all employees are aware of the latest 

managed by our experienced commercial 

developments. 

teams. 

Team meetings are encouraged at least 

We look to create an environment where 

once a week, with line managers then 

all employees can excel and value both 

reporting directly into the CEO every week 

practical experience as well as academic 

to ensure cohesion across the business. 

qualifications. We believe in investing in 

This also allows any concerns from 

our workforce to maintain a low turn-

employees to be raised with line managers 

over rate and build an agile and adaptive 

and escalated to the Executive team in a 

workforce who can successfully navigate 

timely manner if required. 

the ever-evolving industry landscape to 

maintain our competitive positioning. We 

support employees with further education 

and qualifications, in-house support for 

the development of managerial roles 

and provide a remuneration and benefits 

framework that supports a healthy work/

life balance and is competitive with 

industry standards. 

47

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Stakeholder 
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Why?

Customers and 
Key Opinion 
Leaders

We, including our strategic partners, 
work with several prestigious key opinion 
leaders across clinical settings in order 
to assist with physician conversion and 
drive the clinical discussion around the 
differentiating properties of our product 
portfolio. 

This type of engagement and clinical 
advocacy is crucial as we work to grow our 
clinical data portfolio, improve product 
and brand recognition and increase the 
number of patients who can benefit from 
our market-leading product portfolio.

Suppliers 

Suppliers are fundamental to the Group’s 
ability to source high-quality raw materials 
and ethically sourced and handled tissues. 
We look to partner with suppliers who 
can augment our internal capabilities and 
build long-term beneficial relationships, 
ultimately delivering end customer value. 

During 2020, ensuring strong relationships 
with suppliers was a key priority to ensure 
delivery and payment practices were 
transparent and business expectations and 
requirements could be met. 

The Board monitors risks associated 
with suppliers and ensures that second 
sourcing options are available to minimise 
any business disruption should a supplier 
relationship fail.

How?

What were the key topics of engagement and consideration in principal decisions, 2020

Our clinical affairs team work closely with 
our key opinion leaders and engage with 
them for a number of clinical case studies, 
which can then be used as evidence when 
discussing with new potential customers.

Due to the COVID-19 pandemic, our 
methods of interacting with our key 
opinion leaders and customers has evolved 
to accommodate travel restrictions and 
the cancellation of face-to-face meetings. 
In place we have undertaken a number of 
meetings and training opportunities over 
social media and digital meeting platforms. 

The TRX BioSurgery Distributor Depot was 
also launched, a dedicated secure website 
hosting all of the information and training 
aids potentially required by customers and 
distributors in one easily accessible location. 

The Group has in place a code of conduct 
and integrity that it expects all suppliers 
to meet. Audits of suppliers take place to 
ensure that donated porcine or human 
tissue is handled ethically and in line with 
the Group’s standards. The Executive 
management review supplier payment 
practices and ensure that all suppliers are 
paid in a timely manner, and costs of such 
supplies are in line with industry standards. 

Key topics of engagement for customers and key opinion leaders throughout the year was around: 

Changing practices and expectations regarding performance of clinical solutions. 

Different ordering patterns due to COVID-19.

New product development opportunities.

Consideration in principal decisions:

When deciding the Group’s course of action in response to the COVID-19 pandemic, management liaised 

closely with customers and key opinion leaders to plan out processing and inventory requirements. 

The Group also launched a new soft tissue orthopaedic product into the US market in May 2020, in 

collaboration with a top 10 global healthcare company. Due to the wider market dynamics and the group’s 

cash position at that time, the Board carefully considered the implications of launching a product at this 

time. 

Key topics of engagement for suppliers throughout the year was around: 

The implication of the COVID-19 pandemic. Including different ordering patterns, availability of supplies 

(especially PPE), and any payment practices. 

Consideration in principal decisions: 

The Board consider and review suppliers when approving the Groups strategy and commercial expansion 

plans to ensure that enough high-quality materials are sourced at reasonable prices to allow for continuation 

and ramp up of processing. 

Consultation with key suppliers was undertaken ahead of a commitment to continue processing during the 

COVID-19 pandemic to ensure that donors and supplies of all required materials and PPE could be sourced 

and maintained. 

The Board was presented with the overall plan and proposals from multiple contractors as well as 

management’s recommendation, with a decision being made based on cost, timing and references. 

Society 
(including 
environment)

The Group is committed to operating 
with a high level of corporate social 
responsibility and environmental 
sustainability, minimising its environmental 
impact to benefit society as a whole. 

The Group ensures to monitor and improve 
its environmental impact and sustainability 
through upgrading current practices and 
implementing new initiatives during the 
capacity expansion project. 

Consideration in principle decisions:

During the planning of the capacity expansion project in San Antonio, careful consideration was given to the 

energy usage and environmental impact of the new building. 

Likewise, with the relocation of the UK facility the Group looked to implement initiatives to ensure that the 

new production processes did not have a negative impact on the Group’s environmental footprint. 

The Group also looks to engage with the 
local communities and support relevant 
charities wherever possible. 

48

TISSUE REGENIX GROUP PLCANNUAL REPORT AND ACCOUNTS FOR THE YEAR ENDED 31 DECEMBER 2020 
  
Stakeholder 

group

Why?

How?

What were the key topics of engagement and consideration in principal decisions, 2020

Customers and 

Key Opinion 

Leaders

We, including our strategic partners, 

Our clinical affairs team work closely with 

work with several prestigious key opinion 

our key opinion leaders and engage with 

leaders across clinical settings in order 

them for a number of clinical case studies, 

to assist with physician conversion and 

which can then be used as evidence when 

drive the clinical discussion around the 

discussing with new potential customers.

differentiating properties of our product 

portfolio. 

Due to the COVID-19 pandemic, our 

methods of interacting with our key 

This type of engagement and clinical 

opinion leaders and customers has evolved 

advocacy is crucial as we work to grow our 

to accommodate travel restrictions and 

clinical data portfolio, improve product 

the cancellation of face-to-face meetings. 

and brand recognition and increase the 

In place we have undertaken a number of 

number of patients who can benefit from 

meetings and training opportunities over 

our market-leading product portfolio.

social media and digital meeting platforms. 

The TRX BioSurgery Distributor Depot was 

also launched, a dedicated secure website 

hosting all of the information and training 

aids potentially required by customers and 

distributors in one easily accessible location. 

Suppliers 

Suppliers are fundamental to the Group’s 

The Group has in place a code of conduct 

ability to source high-quality raw materials 

and integrity that it expects all suppliers 

and ethically sourced and handled tissues. 

to meet. Audits of suppliers take place to 

We look to partner with suppliers who 

ensure that donated porcine or human 

can augment our internal capabilities and 

tissue is handled ethically and in line with 

build long-term beneficial relationships, 

the Group’s standards. The Executive 

ultimately delivering end customer value. 

management review supplier payment 

practices and ensure that all suppliers are 

paid in a timely manner, and costs of such 

supplies are in line with industry standards. 

During 2020, ensuring strong relationships 

with suppliers was a key priority to ensure 

delivery and payment practices were 

transparent and business expectations and 

requirements could be met. 

The Board monitors risks associated 

with suppliers and ensures that second 

sourcing options are available to minimise 

any business disruption should a supplier 

relationship fail.

Key topics of engagement for customers and key opinion leaders throughout the year was around: 
Changing practices and expectations regarding performance of clinical solutions. 
Different ordering patterns due to COVID-19.
New product development opportunities.

Consideration in principal decisions:
When deciding the Group’s course of action in response to the COVID-19 pandemic, management liaised 
closely with customers and key opinion leaders to plan out processing and inventory requirements. 

The Group also launched a new soft tissue orthopaedic product into the US market in May 2020, in 
collaboration with a top 10 global healthcare company. Due to the wider market dynamics and the group’s 
cash position at that time, the Board carefully considered the implications of launching a product at this 
time. 

Key topics of engagement for suppliers throughout the year was around: 
The implication of the COVID-19 pandemic. Including different ordering patterns, availability of supplies 
(especially PPE), and any payment practices. 

Consideration in principal decisions: 
The Board consider and review suppliers when approving the Groups strategy and commercial expansion 
plans to ensure that enough high-quality materials are sourced at reasonable prices to allow for continuation 
and ramp up of processing. 

Consultation with key suppliers was undertaken ahead of a commitment to continue processing during the 
COVID-19 pandemic to ensure that donors and supplies of all required materials and PPE could be sourced 
and maintained. 

The Board was presented with the overall plan and proposals from multiple contractors as well as 
management’s recommendation, with a decision being made based on cost, timing and references. 

Society 

(including 

environment)

The Group is committed to operating 

The Group ensures to monitor and improve 

with a high level of corporate social 

its environmental impact and sustainability 

responsibility and environmental 

through upgrading current practices and 

sustainability, minimising its environmental 

implementing new initiatives during the 

impact to benefit society as a whole. 

capacity expansion project. 

Consideration in principle decisions:
During the planning of the capacity expansion project in San Antonio, careful consideration was given to the 
energy usage and environmental impact of the new building. 

Likewise, with the relocation of the UK facility the Group looked to implement initiatives to ensure that the 
new production processes did not have a negative impact on the Group’s environmental footprint. 

The Group also looks to engage with the 

local communities and support relevant 

charities wherever possible. 

Non-financial information 
The below table summarises where non-financial information is included in the Annual Report  
and Accounts: 

Reporting requirements 

Page location

Environmental matters 

Environmental KPI on page 22 and performance on page 44

Employees 

Human rights 

As discussed in sustainability pages 44 to 45

Modern slavery statement on page 44 

Anti-corruption and anti-bribery matters 

Ethics and compliance on page 44 

Social matters 

Business model 

Principal risks 

Non-financial KPIs 

As discussed in sustainability pages 44 to 45

Business model on pages 14 to 15 

Risk management on pages 38 to 43 

Key performance indicators on pages 22 to 23 

The Strategic Report on pages 10 to 49 was approved by the Board on 27 April 2021.

Daniel Lee 
Chief Executive Officer, Tissue Regenix Group

49

STRATEGIC REPORTTISSUE REGENIX GROUP PLC

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50

Jonathan Glenn

Non-Executive Chair

Daniel Lee 
Chief Executive Officer 

David Cocke 
Chief Financial Officer 

Shervanthi  

Trevor Phillips 

Brian Phillips 

Non-Executive Director 

Non-Executive Director 

Homer-Vanniasinkam

Non-Executive Director

Joined the group: January 2016

Joined the group: January 2019

Joined the group: January 2021

Joined the group: June 2016

Joined the group: January 2021

Joined the group: January 2021

Committees: 

Committees: N/A

Committees: N/A

Committees: 

Committees: 

Committees: 

External appointments: N/A

External appointments: N/A

External appointments: N/A

Jonathan was most recently CEO 
of Consort Medical from December 
2007 until its acquisition for 
£505m by Recipharm AB in early 
2020. Jonathan originally joined 
Consort Medical as Group Finance 
Director from September 2006 
to December 2007, and prior to 
this, Jonathan was global Head 
of Finance at Celltech Group plc, 
and later Chief Financial Officer of 
Akubio Ltd, a Cambridge-based 
developer of instrumentation for 
the life sciences industry. Jonathan 
is a member of the Institute of 
Chartered Accountants in England 
and Wales.

Daniel R. Lee has nearly 30 years 
experience in the medical device 
and biologics industry ranging 
from product innovation to 
commercialisation to corporate 
management. He joined Tissue 
Regenix Group as President of US 
Operations in January 2019, before 
being appointed as CEO of the 
Tissue Regenix Group in November 
2020. 

Prior to joining this, Danny was the 
Chief Executive Officer for Scaffold 
Biologics and Aperion Biologics. 
His previous senior management 
roles included global marketing 
for OsteoBiologics (acquired by 
Smith & Nephew Endoscopy in 
1996) and marketing activities for 
Regeneration Technologies (now 
RTI Surgical), a leading allograft 
tissue processor. Danny spent the 
first ten years of his career in R&D 
with the U.S. Surgical Corporation 
(now Medtronic). Danny received 
his B.E.S. degree in Materials 
Science and Engineering from the 
Johns Hopkins University and his 
M.S. in Biomedical Engineering 
from the University of Alabama at 
Birmingham. He has 13 patents on 
implants and instruments used in 
orthopedic and general surgery. 
Danny Is also a Certified Tissue 
Bank Specialist (CTBS) from the 
American Association of Tissue 
Banks (AATB).

David C. Cocke has over 29 years of 
experience in the medical device 
industry holding senior finance 
and operations positions. In 1997, 
David was a founding partner of 
NuPak Medical, an ISO-certified 
contract manufacturer of sterile 
disposable medical devices. 
NuPak Medical was acquired by 
Katena Products, Inc. in 2017 and 
David remained with the business 
post-acquisition until joining 
Tissue Regenix in January 2021. 
David was also Chief Financial 
Officer at Aperion Biologics from 
2008-2017. Prior to this, David was 
Senior Director for Finance and 
Operations at Kinetic Concepts 
from 1993-1996. 

David began his career in the 
corporate finance sector, working 
at GE Capital in its Corporate 
Finance Group and at Salomon 
Brothers Inc in its Investment 
Banking Group. 

David received his B.B.A in 
Business Honors (magna cum 
laude) from the University of Texas 
at Austin and his M.B.A from the 
University of Virginia’s Darden 
Graduate School of Business 
Administration. He has two patents 
covering medical devices.

External appointments: 

Chairman of the Board at 

NEPeSMO

Trevor Phillips is the current 

Chairman of the Board at 

NEPeSMO and has extensive 

experience in the UK and US in 

corporate development, M&A and 

operations in the pharmaceutical 

and life science industries, 

including previously held positions 

as Executive Chairman of hVIVO 

(2017-2020), Chief Operating 

Officer for Vectura Group plc 

(2011-2017) and former CEO and 

COO of Critical Therapeutics, Inc. 

(2002-2008). Trevor holds a BSc, 

Microbiology from the University 

of Reading, a PhD, Microbial 

Biochemistry from Swansea 

University and an MBA from 

Henley Business School.

External appointments: N/A

Brian Phillips is an entrepreneurial 

investment professional with 

over 25 years’ experience. Brian 

is the current Principal of Ethos 

partners which he co-founded 

in 2018 to assist individuals in 

establishing a portfolio of assets 

under private equity investments. 

Prior to this, Brian was Chief 

Investment Officer at Greenhill 

Capital Partners Europe LLP where 

he was responsible for setting 

up their UK business (2006-2010) 

and Managing Director of LGV 

Capital (2000-2006). Brian holds 

a B.Acc from Glasgow University 

and qualified as a Chartered 

Accountant with KMPG. 

External appointments: N/A

Shervanthi Homer-Vanniasinkam 

graduated in medicine from 

Mysore University Medical School 

in India, and is a Fellow of both 

the Royal College of Surgeons of 

Edinburgh, and the Royal College 

of Surgeons of England. She was 

appointed Consultant Vascular 

Surgeon at Leeds General Infirmary 

in 1995, a post she continues to 

hold. Her concomitant posts 

include: Founding Co-Director of 

the novel medical undergraduate 

scholarship programme, 

EXSEL@Leeds; Founding 

Professor of Surgery, University 

of Warwick Medical School & 

University Hospitals Coventry 

and Warwickshire; Professor of 

Engineering & Surgery, University 

College London.

Professor Homer-Vanniasinkam 

has published over 100 papers and 

book chapters, delivered over 300 

presentations, and has a significant 

research grant portfolio (several £m, 

to date). She has an outstanding 

track record of national (Universities 

of Leeds, London, Warwick) and 

international (Harvard, Yale, 

Singapore, India) collaborative 

research programmes that 

encompass basic, translational and 

clinical studies. Professor Homer-

Vanniasinkam is currently a Visiting 

Scholar at Harvard University 

and the Yeoh Ghim Seng Visiting 

Professor of Surgery at the National 

University of Singapore.

ANNUAL REPORT AND ACCOUNTS FOR THE YEAR ENDED 31 DECEMBER 2020 
 
  
 
 
 
 
 
 
 
 
 
 
Jonathan Glenn

Non-Executive Chair

Daniel Lee 

David Cocke 

Chief Executive Officer 

Chief Financial Officer 

Shervanthi  
Homer-Vanniasinkam
Non-Executive Director

Trevor Phillips 
Non-Executive Director 

Brian Phillips 
Non-Executive Director 

Joined the group: January 2016

Joined the group: January 2019

Joined the group: January 2021

Joined the group: June 2016

Joined the group: January 2021

Joined the group: January 2021

Committees: 

Committees: N/A

Committees: N/A

Committees: 

Committees: 

Committees: 

External appointments: N/A

External appointments: N/A

External appointments: N/A

Jonathan was most recently CEO 

Daniel R. Lee has nearly 30 years 

David C. Cocke has over 29 years of 

of Consort Medical from December 

experience in the medical device 

experience in the medical device 

2007 until its acquisition for 

and biologics industry ranging 

industry holding senior finance 

£505m by Recipharm AB in early 

from product innovation to 

and operations positions. In 1997, 

2020. Jonathan originally joined 

commercialisation to corporate 

David was a founding partner of 

Consort Medical as Group Finance 

management. He joined Tissue 

NuPak Medical, an ISO-certified 

Director from September 2006 

Regenix Group as President of US 

contract manufacturer of sterile 

to December 2007, and prior to 

Operations in January 2019, before 

disposable medical devices. 

this, Jonathan was global Head 

being appointed as CEO of the 

NuPak Medical was acquired by 

of Finance at Celltech Group plc, 

Tissue Regenix Group in November 

Katena Products, Inc. in 2017 and 

and later Chief Financial Officer of 

2020. 

Akubio Ltd, a Cambridge-based 

developer of instrumentation for 

the life sciences industry. Jonathan 

is a member of the Institute of 

Chartered Accountants in England 

and Wales.

Prior to joining this, Danny was the 

Chief Executive Officer for Scaffold 

Biologics and Aperion Biologics. 

His previous senior management 

roles included global marketing 

for OsteoBiologics (acquired by 

Smith & Nephew Endoscopy in 

1996) and marketing activities for 

David remained with the business 

post-acquisition until joining 

Tissue Regenix in January 2021. 

David was also Chief Financial 

Officer at Aperion Biologics from 

2008-2017. Prior to this, David was 

Senior Director for Finance and 

Operations at Kinetic Concepts 

from 1993-1996. 

Regeneration Technologies (now 

David began his career in the 

RTI Surgical), a leading allograft 

corporate finance sector, working 

tissue processor. Danny spent the 

at GE Capital in its Corporate 

first ten years of his career in R&D 

Finance Group and at Salomon 

with the U.S. Surgical Corporation 

Brothers Inc in its Investment 

(now Medtronic). Danny received 

Banking Group. 

his B.E.S. degree in Materials 

Science and Engineering from the 

Johns Hopkins University and his 

M.S. in Biomedical Engineering 

from the University of Alabama at 

Birmingham. He has 13 patents on 

implants and instruments used in 

orthopedic and general surgery. 

Danny Is also a Certified Tissue 

Bank Specialist (CTBS) from the 

American Association of Tissue 

Banks (AATB).

David received his B.B.A in 

Business Honors (magna cum 

laude) from the University of Texas 

at Austin and his M.B.A from the 

University of Virginia’s Darden 

Graduate School of Business 

Administration. He has two patents 

covering medical devices.

External appointments: 
Chairman of the Board at 
NEPeSMO

Trevor Phillips is the current 
Chairman of the Board at 
NEPeSMO and has extensive 
experience in the UK and US in 
corporate development, M&A and 
operations in the pharmaceutical 
and life science industries, 
including previously held positions 
as Executive Chairman of hVIVO 
(2017-2020), Chief Operating 
Officer for Vectura Group plc 
(2011-2017) and former CEO and 
COO of Critical Therapeutics, Inc. 
(2002-2008). Trevor holds a BSc, 
Microbiology from the University 
of Reading, a PhD, Microbial 
Biochemistry from Swansea 
University and an MBA from 
Henley Business School.

External appointments: N/A

Brian Phillips is an entrepreneurial 
investment professional with 
over 25 years’ experience. Brian 
is the current Principal of Ethos 
partners which he co-founded 
in 2018 to assist individuals in 
establishing a portfolio of assets 
under private equity investments. 
Prior to this, Brian was Chief 
Investment Officer at Greenhill 
Capital Partners Europe LLP where 
he was responsible for setting 
up their UK business (2006-2010) 
and Managing Director of LGV 
Capital (2000-2006). Brian holds 
a B.Acc from Glasgow University 
and qualified as a Chartered 
Accountant with KMPG. 

External appointments: N/A

Shervanthi Homer-Vanniasinkam 
graduated in medicine from 
Mysore University Medical School 
in India, and is a Fellow of both 
the Royal College of Surgeons of 
Edinburgh, and the Royal College 
of Surgeons of England. She was 
appointed Consultant Vascular 
Surgeon at Leeds General Infirmary 
in 1995, a post she continues to 
hold. Her concomitant posts 
include: Founding Co-Director of 
the novel medical undergraduate 
scholarship programme, 
EXSEL@Leeds; Founding 
Professor of Surgery, University 
of Warwick Medical School & 
University Hospitals Coventry 
and Warwickshire; Professor of 
Engineering & Surgery, University 
College London.

Professor Homer-Vanniasinkam 
has published over 100 papers and 
book chapters, delivered over 300 
presentations, and has a significant 
research grant portfolio (several £m, 
to date). She has an outstanding 
track record of national (Universities 
of Leeds, London, Warwick) and 
international (Harvard, Yale, 
Singapore, India) collaborative 
research programmes that 
encompass basic, translational and 
clinical studies. Professor Homer-
Vanniasinkam is currently a Visiting 
Scholar at Harvard University 
and the Yeoh Ghim Seng Visiting 
Professor of Surgery at the National 
University of Singapore.

GOVERNA NC E

Key

Committees

   Audit 

Committee

   Chair of Audit 
Committee

   Remuneration 
Committee

    Chair of 

Remuneration 
Committee

51

 
 
 
 
 
 
 
 
 
There is a clear division of responsibility 
between the Chair of the Board and CEO 
position. The Chair advises and leads the Board, 
as well as making themself available to meet 
with shareholders and Company management, 
as required. The CEO is responsible for the day-
to-day execution of the agreed strategy and 
ensuring operational compliance. 

The Board aims to meet formally at least 10 
times a year, with provision being made to 
join via telephone if a member of the Board is 
unable to attend in person. During 2020, due to 
the social distancing and lockdown restrictions 
imposed in response to COVID-19, Board 
meetings were held via video conferencing 
and telephone. It is expected that as the CEO 
and CFO are now based in the US, Board 
meetings will continue in this format. Outside 
of the scheduled meetings, the Board will 
meet to discuss ad hoc business events where 
necessary, and the CEO keeps the Board fully 
informed of any business developments that 
could positively or negatively impact the 
performance or value of the Company; any 
business decisions that require formal Board 
approval, or any event that could impact the 
Board or individual member carrying out 
their duties and regulatory responsibilities. 
Training is made available to each Non-
Executive Director (NED) to ensure that they 
are completely aware of their regulatory 
responsibilities and requirements.

The Board also operates two sub-committees, 
the Audit and Remuneration Committees, to 
ensure compliance with market regulations. 

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Board of Tissue Regenix Group 
recognises the importance of 
N
strong corporate governance 
A
and business ethics. The Group 
N
adopted the latest Quoted 
R
Company Alliance (QCA) 
Corporate Governance Code, 
E
and has implemented these 
V
guidelines as far as possible. 
O
The QCA Code is based around 
10 principles which it considers 
G
to be appropriate for small 
to mid-size companies, with 
companies following this code 
expected to comply with these 
principles or explain why they 
should deviate away from the 
principle and disclosures. 

The Board is ultimately accountable to the 
Group’s shareholders for good corporate 
governance, and this report along with the 
audit, remuneration and risk reports, highlight 
the steps taken to ensure that the Group takes 
action to comply with the expected standards.

The roles and responsibilities 
of the Board
The Board is responsible for ensuring that a 
successful business strategy is implemented 
across the Group to drive commercial success 
and deliver value for shareholders.

The Board is comprised of three independent 
Non-Executive Directors, the Non-Executive 
Chairman, and two Executive Directors, 
the Chief Executive Officer and the Chief 
Financial Officer. The Board reviewed its size, 
composition and balance of skills during 2020 
and following the resignation of Randeep 
Grewal and Alan Miller, subsequently 
appointed Trevor Phillips and Brian Phillips 
to the Board as independent Non-Executive 
Directors. The Board considers that its 
composition is now in line with the current 
requirements of the Group, with a mix of 
financial, clinical, commercial and operational 
expertise to advise the Group on its chosen 
commercial strategy. 

52

TISSUE REGENIX GROUP PLCANNUAL REPORT AND ACCOUNTS FOR THE YEAR ENDED 31 DECEMBER 2020  
The Audit Committee
Details of all Board members can be found on 
pages 50 to 51. 

The Audit Committee’s primary responsibilities 
are to monitor the integrity of the financial 
affairs and statements of the Group, to ensure 
that the financial performance of the Group 
and any subsidiary is properly measured 
and reported, and to review reports from 
the Group’s external auditors relating to the 
accounting and internal controls. The Audit 
Committee also recommends to the Board the 
appointment and reappointment of external 
auditors. The Audit Committee considers 
the scope and results of the external audit 
and its cost effectiveness. It also reviews 
the fees, independence and objectivity of 
the external auditors by discussing with the 
auditors their annual assessment regarding 
their independence, policies and procedures, 
and analysing the audit and non-audit work. 
The Audit Committee also plays a key role in 
supporting the Board with the ongoing risk 
assessment and management framework for 
the Group. 

The Group’s external auditors have unrestricted 
access to the Audit Committee and attend the 
Audit Committee meetings throughout the 
year. The Executive Directors attend the Audit 
Committee meeting by invitation only. 

The Audit Committee comprises of Brian 
Phillips, who acts as Chairman of the 
Committee, Trevor Phillips and Jonathan 
Glenn.

Brian  
Phillips

Trevor  
Phillips

Jonathan 
Glenn

Details of the perceived risk appetite of the 
Board is available on pages 38 to 43. 

The Remuneration  
Committee Report 
The Remuneration Committee report is 
available on pages 58 to 59. 

The Remuneration Committee comprises of 
Trevor Phillips, who acts as Chairman of the 
Committee, Brian Phillips and Shervanthi 
Homer-Vanniasinkam. 

Trevor  
Phillips

Brian  
Phillips

Shervanthi 
Homer-
Vanniasinkam

The roles of the Board 
Jonathan Glenn – Non-Executive Chair

 ▶ Ensures the effectiveness of the Board in all 

decision-making

 ▶ Provides guidance to the CEO on key 

business decisions 

 ▶ Facilitates discussions of the Board 

and ensures that all contributions from 
Executive and Non-Executive Directors are 
considered 

 ▶ Makes himself available to all shareholders, 
and Company management, to ensure 
effective communications 

Daniel Lee - CEO 

 ▶ Responsible for the overall operational 

effectiveness of the business 

 ▶ Manages the day-to-day business and 

leads the strategic direction of the Group as 
advised by the Chair of the Board and Non-
Executive Directors

 ▶ Proactively meets with existing and 

potential investors to relay the corporate 
story and investment case

 ▶ Ensures effective communication with all 
employees and promotes collaborative 
working and cohesion between all members 
of the global leadership team 

 ▶ Ensures that the Chair of the Board and 

Non-Executive Directors are provided with 
a comprehensive and accurate business 
update every month via both Board packs 
and, when applicable, Board meetings

David Cocke - CFO

 ▶ Working with the CEO, responsible for the 

strategic vision of the Group

 ▶ Act as an onsite sounding board for the 
CEO, providing advice on operational 
matters

 ▶ Responsible for the oversight of the overall 

financial management of the Group, 
including establishing budgets and 
forecasts

 ▶ Monitors the Group’s performance against 

budgets and forecasts and reports on those 
to the Board

 ▶ Responsible for clear communications with 
providers of capital, both debt and equity

 ▶ Advises the Board on funding strategies for 
the Group as well as the appropriate capital 
structure to promote corporate growth

Kirsten Lund - Company Secretary 

 ▶ Responsible to the Board and ensuring 

compliance with all statutory regulations 

 ▶ Responsible for advising the Board on 

Corporate Governance matters 

 ▶ Responsible under the direction of the 

CEO, for ensuring that the Board receives 
accurate and timely information

53

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Non–Executive Directors 

 ▶ Help to develop the business strategy and 

bring an independent outlook 

 ▶ Chair and participate in the Audit and 

Remuneration Committees

 ▶ Challenge and support the Executive 

Director on the main issues affecting the 
Group 

 ▶ Bring a range of complementary experience 

to the Board to assist with business 
decision-making 

 ▶ Are available if shareholders want to 

raise concerns that normal channels of 
communication have failed to resolve

Internal control
The Board is responsible for maintaining 
a sound system of internal controls. These 
measures are designed to minimise any 
potential risks identified and provide 
reasonable, but not absolute assurance 
against material misstatement or loss. The 
Board confirms that it has established a sound 
system of internal controls. Some key features 
of the internal control system are: 

 ▶ well established financial reporting and 

control systems

 ▶ the Board actively identifies, evaluates and 
monitors the risks inherent in the business 
and ensure that appropriate controls and 
procedures are in place to manage these 
risks

 ▶ there is a clearly designed organisation and 

reporting structure

 ▶ the Company has operational, accounting 

and employment policies in place

In addition, the Board regularly assess the 
internal control environment under which 
the business operates and where appropriate 
implements additional measures to ensure 
that adequate controls are maintained.

Quoted Company Alliance 
Corporate Governance Code 
The Board has concluded that the most 
applicable corporate governance framework 
for the Group to follow is the Quoted Company 
Alliance Corporate Governance Code, which 
the Group implemented in September 2018. 
Below is an overview as to how the Group 
addresses the 10 principles of the Code. 

1.  “Establish a strategy and business model which 

promote long-term value for shareholders”

Tissue Regenix Group has established a 
portfolio of regenerative medical products, 
based on two platform technologies, to 
address critical and increasing clinical needs, 
transforming patient care and providing 
favourable health economic outcomes. We 
aim to expand the adoption of our dCELL® 
and BioRinse® technologies and become 
a partner of choice for both clinicians and 
strategic partners. We aim to optimise the 

adoption of our products and drive additional 
revenues more rapidly through product line 
extensions, which have a quick route to market, 
and address specific clinical requirements 
where we see significant opportunities. 
Underpinning this, the business has adopted 
four key strategic growth drivers that it 
believes will accelerate market penetration 
and revenue growth, namely: accelerate US 
market penetration; exploit global market 
potential; broaden strategic partnerships; and 
strengthen the portfolio. More details of these 
strategic growth drivers can be found on pages 
16 to 19 of this report. 

2.  “Seek to understand and meet shareholder 

needs and expectations”

The Group actively engages with its 
shareholders throughout the year both 
through direct meetings, website and social 
media communications and stock exchange 
announcements. Commissioned analyst 
research notes are made available on the 
Company’s website as well as clinical case 
studies and published papers. 

Senior management, typically the CEO 
and CFO aim to meet with, or speak with, 
significant shareholders at least twice in a 
year usually after the interim and annual 
results announcements, to provide an update 
on strategy and progress of the Group as a 
whole, and to receive shareholder feedback. 
The Company also undertakes several publicly 
available updates to all shareholders, through 
forums such as interviews, trading updates and 
PR announcements. In September 2020, the 
Group undertook its first ‘Investor meet’ retail 
investor presentation as part of the interim 
results investor roadshow, with 58 individuals 
attending live via video conferencing and 
a further 44 receiving the presentation on 
demand. 

The Company holds an Annual General 
Meeting each year at which all shareholders 
are welcome to attend and speak with 
management.

Company contact details are included on 
the Company’s website and on all regulatory 
announcements.

3.  “Take into account wider stakeholder and social 
responsibilities and their implications for long-
term success” 

The Board of Directors of the Company considers 
relationships with stakeholders of the Tissue 
Regenix Group as fundamental to its success.

A key stakeholder in the success of the Group 
is a well-supported and motivated employee 
base. We have set out a clear Company 
culture, vision, mission and values which we 
believe are important in establishing and 
ensuring a healthy working environment. More 
information can be found in the sustainability 
report on pages 44 to 45.

TISSUE REGENIX GROUP PLCANNUAL REPORT AND ACCOUNTS FOR THE YEAR ENDED 31 DECEMBER 2020  
 
In relation to our joint venture company GBM-v 
in Rostock, Germany, quarterly Board meetings 
are held involving both joint venture parties 
along with less formal monthly update calls.

We actively audit our organ procurement 
organisation partners and tissue suppliers 
on a regular basis, to ensure that donations 
are from a properly regulated source and 
obtained and handled with the highest ethical 
standards.

The nature of our business means that we 
pay close attention to our corporate social 
responsibilities. As part of this we ensure to 
track each donation, and wherever requested, 
by either regulatory bodies or next of kin, are 
in a position to provide further information 
around the use of donation. 

We consider our environmental sustainability 
in every aspect of the business and have 
taken a number of steps to reduce our carbon 
footprint, energy consumption and improve 
our waste management; these initiatives 
were even more important during 2020 as 
we commenced the capacity expansion 
programme in San Antonio and undertook the 
relocation of the UK facility. Further details of 
our corporate social responsibility strategy are 
set out at page 45 of this report.

The Board considers feedback from its advisers 
and stakeholders formally at Board meetings 
or sooner on a more informal basis as required.

4.  “Embed effective risk management, considering 
both opportunities and threats, throughout the 
organisation”

The Board carefully considers the strengths, 
weaknesses, opportunities and risks facing 
the Tissue Regenix Group, and endeavours 
to minimise the impact of weaknesses and 
risks by employing the necessary mitigating 
actions. Tissue Regenix Group is a pioneering 
international medical technology company, 
focusing on the development of regenerative 
products utilising two platform technologies. 
We are helping to transform the treatment 
of patients in four key areas: BioSurgery (soft 
tissue replacement and repair in wound care, 
urogynaecology and trauma), Orthopaedics 
and Dental, and Ophthalmology. We process 
tissues at our facilities in the UK, Europe and 
North America. Tissue Regenix Group has an 
experienced and dedicated management and 
scientific team, and the prominent risks facing 
the Group are kept under review and updated 
as necessary; the Board ensures to review a 
detailed risk matrix on a rolling basis as part of 
the formal Board meetings. Details of the risk 
framework and prominent risks identified are 
set out on pages 38 to 43 of this report.

Tissue Regenix maintains a central finance 
team, with three team members based in 
the UK and three in the US. The Group seeks 
to operate consistent accounting policies 
and engages annual external audits from 
professional auditors of its financial results 
and reports, findings from which will be 

presented to the Board and made available 
to all shareholders. The Board review monthly 
financial reports including key performance 
indicators provided by the CFO in respect of 
the management of cash within the business 
and review against budgets and forecasts. 

The Group also has a number of operational 
controls that all employees are expected to 
adhere to including management structure, 
Board reserved matters, financial monitoring, 
internal policies, codes of conduct and training, 
health and safety monitoring and IT controls. 
The regulatory and quality teams at each 
facility ensure to implement and maintain a 
comprehensive quality management system 
with each employee having a personal training 
record. 

As noted above, the Group regularly audits its 
suppliers to ensure that the highest ethical 
standards are maintained.

In respect of its intellectual property rights, 
the Group engages a professional patent and 
trademark attorney to monitor its intellectual 
property portfolio.

5.  “Maintain the Board as a well-functioning, 

balanced team led by the Chair”

The Board is comprised of three independent 
Non-Executive Directors, the Non-Executive 
Chairman, and two Executive Directors, the 
Chief Executive Officer and the Chief Financial 
Officer. The Non-Executive Directors bring 
a mix of financial, clinical, operational and 
commercial experience to the Board. During 
2020, there were a number of changes to 
the Board following the resignation of the 
Executive Chairman, CEO and latterly, two 
Non-Executive Directors. After reviewing the 
requirements of the Group and the proposed 
corporate and commercial strategy, new 
appointments to the Board were made and 
the Board believes that its size, composition 
and skillset is now suitable for the Company 
requirements. 

At least 10 formal Board meetings are held 
each year with enough notice for members 
to participate. A monthly Board report is 
produced, and meeting agendas and Board 
papers are circulated in advance of each 
meeting so that the Board can properly 
consider the matters to be discussed. 
Board members are also expected to make 
themselves available on an ad hoc basis for 
consultation if the need arises. The Company 
maintains minutes of formal and ad hoc Board 
meetings. 

There are two Committees of the Board, the 
Audit Committee and the Remuneration 
Committee, each of which are formed of three 
of the Non-Executive Directors of the Company, 
with each Committee having their own Terms 
of Reference to govern how they are run. 
The Audit Committee meets at least twice 
per year and is chaired by Brian Phillips who 
is a Chartered Accountant and has relevant 
financial experience. The Remuneration 

55

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Committee meets no fewer than twice per year 
and is chaired by Trevor Phillips who has many 
years of relevant operational and commercial 
industry experience. Further details of these 
Committees can be found on page 53 of this 
Annual Report.

For senior level appointments the Board may 
engage the expertise of a relevant recruitment 
consultant to assist with the search and hiring 
of a relevant individual, as per the process to 
appoint the Chief Executive Officer in 2020. 

The Non-Executive Directors are appointed 
through formal non-executive appointment 
letters, which contain a three-month notice 
period. The non-executive appointment letters 
contain an indicative time commitment of 20 
days per annum; however, these indicate that 
this is an estimate and that all Directors are 
expected to commit sufficient time to fully 
discharge their responsibilities. The Company 
has not had any issues with regular non-
attendance at meetings.

Executive Directors have formal service 
contracts, which require them to work full-time 
in the business and have no other significant 
outside business commitments. These service 
agreements have a maximum of six-months’ 
notice to terminate.

The Company follows the provisions in its 
Articles of Association in respect of the 
retirement and reappointment of Directors at 
its Annual General Meeting each year.

The Board is satisfied that it has a suitable 
balance between independence and 
knowledge of the business to allow it to 
discharge its duties and responsibilities 
effectively and that effective controls have 
been put in place.

6.  “Ensure that, between them, the Directors have 
the necessary up-to-date experience, skills and 
capabilities”

The Board is satisfied that it has an effective 
balance of skills and relevant experience to 
operate effectively.

During 2020, two new Non-Executive 
Directors; Trevor Phillips and Brian Phillips, 
were appointed to the Board following the 
resignations of Alan Miller and Randeep 
Grewal. These appointments were undertaken 
due to the relevant skills and experience that 
both Brian and Trevor could bring to the 
business at this stage of development, and 
to advise the Group in order to successfully 
execute the corporate and commercial 
strategy. 

The Board members have complementary 
skillsets and bring different experience to 
the Board which is pivotal in the success of 
the Group. Daniel Lee and Trevor Phillips 
and David Cocke have significant industry 
and operational experience whilst Jonathan 
Glenn has commercial, industry and financial 
experience. Shervanthi Homer-Vanniasinkam 

is a respected vascular surgeon and brings 
extensive clinical expertise, Brian Phillips is 
a chartered accountant and experienced 
investment professional. 

The Board members maintain their skillsets 
through their day-to-day roles and use 
external advisers to enhance knowledge 
where necessary. If any member of the Board 
considers that additional training is required 
to fulfil their role, the Company would seek to 
provide such training as and when necessary.

The Company keeps in regular contact with 
its nominated adviser, Stifel Nicolaus Europe, 
typically meeting once every two weeks and 
ad hoc as required. The Company also seeks 
advice from its legal advisers and accountants 
as and where necessary. The Company 
employs RSM UK Audit LLP to audit its Annual 
Accounts and Report.

The Company Secretary role is currently held 
by the Group Finance Director, Kirsten Lund.

Given the size of the Company, it has 
not sought to formally appoint a Senior 
Independent Director. 

7.  “Evaluate Board performance based on clear 
and relevant objectives, seeking continuous 
improvement” 

The CEO and CFO of the Company are 
measured against a clearly defined set of 
personal objectives agreed by the Board and 
monitored by the Remuneration Committee. 
The Board keeps under review its composition 
and the balance of skills and experience of 
Non-Executive Directors. The Board undertook 
a review of corporate governance practices 
during 2020 and as part of this, intends to 
begin Board member appraisals and a formal 
Board appraisal process during 2021. 

8.  “Promote a corporate culture that is based on 

ethical values and behaviours”

As a Company that operates in a highly 
regulated and sensitive environment, the 
Company ensures that it operates with 
a vigorous code of conduct and ethics. 
Tissue Regenix Group strives to maintain a 
sustainable and ethically responsible Company. 

The Group, led by the Chief Executive Officer, 
maintains open and transparent channels of 
communication with all employees in order 
to promote values and behaviours which 
consistently reflect the Group’s ethos, and to 
ensure that employees are aware of Company 
developments and successes. 

Operating in an industry based upon the 
processing of human and animal derived 
tissues demands the highest ethical standards, 
and the Group aspires to maintain these 
across all business functions and relations. The 
Company undertakes regular audit checks to 
ensure that partners, suppliers and employees 
comply with the ethical standards and operate 
to meet our expectations. 

TISSUE REGENIX GROUP PLCANNUAL REPORT AND ACCOUNTS FOR THE YEAR ENDED 31 DECEMBER 2020  
9.  “Maintain governance structures and 
processes that are fit for purpose and 
support good decision-making by the 
Board”

Please see the details of the Board and its 
Committees set out in respect of principles 
5, 6 and 7 above. Details of the main roles 
of the Audit Committee and Remuneration 
Committee are set out in this Annual Report on 
page 53, and the Company’s website.

In addition to this, the Group operates a clear 
list of matters which are reserved for the 
Board, and terms of reference for each of the 
committees.

For senior level appointments the Board will 
look to engage the expertise of a relevant 
recruitment consultant to assist with the 
search and hiring of a relevant individual. To 
supplement the Board, the Group maintains a 
team of senior management who inform the 
Board and keep it abreast of key developments 
throughout its business. The senior 
management are detailed on the Company’s 
website and includes for example: Tina Trimble, 
VP Donor Services, Gerald Sharpe, VP Strategic 
Partnerships, Lance Johnson, VP Quality/ 
Regulatory, Kirsten Lund, Group Finance 
Director, and Christine Rowley, Technical 
and Operations Director, UK, as well as other 
relevant senior managers. As well as the main 
Board, Tissue Regenix participates in the Board 
of its joint venture company, GBM-v along 
with its joint venture partner. Having close 
ties to the senior management team and joint 
venture partners in this way allows the Group 
to ensure that all divisions of the business are 
kept up to date and facilitates the Group in 
ensuring that all its divisions are compliant 
with the Group’s codes and practices.

10.  “Communicate how the Company 
is governed and is performing by 
maintaining a dialogue with shareholders 
and other relevant stakeholders”

Please see responses in respect of principles 
2, 3 and 5 above in relation to shareholder 
communications and meetings, and Board 
communications and meetings. In addition 
to this, the Company communicates 
with its shareholders through regulatory 
announcements and its Annual Report.

Reports from both the Remuneration 
Committee and the Audit Committee are 
set out in the Annual Report. The Company 
also hold an Annual General Meeting, which 
all shareholders are invited to attend. In the 
event that the Company received a significant 
proportion of votes against a resolution at a 
General Meeting, it would seek to review the 
rationale for this and consider appropriate 
actions.

57

GOVERNANCEBasic annual salary
The base salary is reviewed annually at the 
beginning of each year. The review process is 
undertaken by the Remuneration Committee 
taking into account several factors, including 
the current position and development of the 
Group, individual contribution and market 
salaries for comparable organisations.

The Committee also approves the level of the 
pool for salary reviews for all staff.

Discretionary annual bonus
All Executive Directors and senior managers 
are eligible for a discretionary annual bonus, 
which is paid in accordance with a bonus 
scheme developed by the Remuneration 
Committee. This takes into account individual 
contribution, business performance and 
commercial progress, in accordance with the 
Group’s strategy along with financial results.

Long term incentive plan
The Company has chosen to replace the 
existing deferred annual bonus (DAB) plan, 
with a new Long Term Incentive Plan (LTIP) for 
Executive Directors and senior management. 
Though this is a post year event the Company 
can confirm that the DAB plan was not utilised 
during 2020.

The LTIP awards will be made annually, starting 
in 2021, to the Executive Directors and those 
senior management members recommended 
to participate by the Executive Directors and 
approved by the Board. 

Awards will be based upon a predetermined 
percentage of an individual’s annual salary 
and will vest over a period of three years. 
The final vesting of the awards will be 
determined by performance against vesting 
criteria, set by the Remuneration Committee 
at the time of grant, and adjudged by the 
Remuneration Committee in the period prior 
to the nominated vesting date. The goals 
will be set against key aspects of Company 
performance, defined to be Total Shareholder 
Return (TSR), Revenue Growth and Profitability 
and individual performance against personal 
performance goals. Weighting has been set 
at 80% of the vesting directed at Company 
performance over the period against the three 
corporate goals and 20% against personal 
performance goals. As part of the LTIP rules 
the Executive Directors will be required to use 
vested LTIPs to build a shareholding in the 
Company to a level of 100% of base salary over 
a period of six years. It is anticipated that the 
first awards will be granted post annual results 
in April 2021.

’

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The Group’s remuneration policy is to provide 
Executive Directors with a competitive 
market-based package in order to reward 
individual and Group performance and deliver 
outstanding shareholder returns.

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The Remuneration Committee is committed to 
ensuring that the Company’s key management 
team is incentivised to drive sustainable 
earnings growth and returns to shareholders, 
thereby creating a genuinely strong alignment 
of interests between management and 
investors.

It is the Company’s policy that Executive 
Directors should have contracts with an 
indefinite term providing for a maximum 
of six months’ notice. In the event of early 
termination, the Executive Directors’ contracts 
provide for compensation up to a maximum of 
basic salary for the notice period.

Non-Executive Directors are employed 
on letters of appointment which may be 
terminated on no less than three months’ 
notice.

Companies with securities listed on AIM do not 
need to comply with the UKLA Listing Rules. 
The Remuneration Committee is, however, 
committed to maintaining high standards 
of corporate governance and disclosure and 
has applied the guidelines as far as practical 
given the current size and development of the 
Company.

Further details on risk in the remuneration 
policy is available on pages 58 to 59. 

Remuneration Committee
The Remuneration Committee’s primary 
responsibilities are to review the performance 
of the Executive Directors of the Company and 
to determine the broad policy and framework 
for their remuneration and the terms and 
conditions of their service and that of senior 
management (including the remuneration of 
and grant of options to such persons under any 
share scheme adopted by the Company).

The 2020 Remuneration Committee comprises 
Trevor Phillips as Chair of the Committee, Brian 
Phillips and Shervanthi Homer-Vanniasinkam. 
The Committee meets no fewer than twice in 
each financial year.

The main elements of the remuneration 
packages for Executive Directors and senior 
management are:

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TISSUE REGENIX GROUP PLCANNUAL REPORT AND ACCOUNTS FOR THE YEAR ENDED 31 DECEMBER 2020  
 
Remuneration policy for Non-Executive Directors
Remuneration for Non-Executive Directors is set by the Chairman and the Executive members of 
the Board. Non-Executives do not participate in bonus schemes.

Directors’ remuneration
The remuneration of the main Board Directors of Tissue Regenix who served in the year to 
31 December 2020 was:

Salary and 
fees
£000

Bonus
£000

Benefits
£000

Total 
December
2020
£000

Total 
December
2019
£000

John Samuel 
(resigned 20/03/20)

Steven Couldwell  
(resigned 30/07/2019)

Gareth Jones ~  
(resigned 17/11/2020)

Randeep Grewal  
(resigned 4/12/2020)

Jonathan Glenn

Alan Miller  
(resigned 4/12/2020)

Shervanthi Homer-
Vanniasinkam

Daniel Lee  
(appointed 16/11/20)

Michael Barker  
(appointed on 28th August 
and resigned  
18th November 2019)

Total

24

–

–

–

347

120

51

30

58

30

28

–

568

–

–

–

–

–

–

120

–

–

23

–

–

–

–

–

–

23

24

–

490

51

30

58

30

28

–

711

111

203

250

35

30

35

30

–

40

734

Within 2019 the total bonus payments were £110k and benefits were £16k. 

~ Included within this salary is £49k for loss of office and £84k in lieu of notice.

Directors’ shareholdings
Directors’ interests in the shares of the Company, including family interests at 31 December 2020 were:

31 December
2020
Number

31 December
2020
%

31 December
2019
Number

31 December
2019
%

Jonathan Glenn

40,600,000

Shervanthi Homer-Vanniasinkam

1,628,222

0.58%

0.02%

600,000

250,000

0.06%

0.02%

On behalf of the Board

Trevor Phillips 
Chairman of the Remuneration Committee

27 April 2021

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report and consolidated 
financial statements for the 
Tissue Regenix Group plc, and 
its subsidiary undertakings for 
the year ended 31 December 
2020.

Principal activity
The principal activity of the Group is 
the exploitation of innovative platform 
technologies in the field of tissue engineering 
and regenerative medicine. The Company is 
principally a holding company incorporated 
and domiciled in the UK and is listed on 
the London Stock Exchange Alternative 
Investment Market. The subsidiary 
undertakings of the Group are listed in note C4 
of the Company’s financial statements.

Business model
A description of the Group’s business model 
is included on pages 14 to 15. Explanations of 
activities and how it seeks to add value are 
included in the Chairman’s statement on page 
04 to 07 and the CEO operational review on 
pages 28 to 33 as well as the KPI report on 
pages 22 to 23 and future milestones on pages 
20 to 21.

Business review and results
A review of the Group’s performance and 
future prospects is included in the Chairman’s 
statement on pages 04 to 07 and CEO 
operational report on pages 28 to 33, as well 
as the future milestones on pages 20 to 21 and 
KPIs set out on pages 22 to 23. A review of the 
Group’s financial performance is within the 
financial overview on pages 34 to 35. The loss 
for the 12 months attributable to equity holders 
of the parent was (£10,139k) (2019: £7,697k). The 
Directors do not recommend the payment of a 
dividend (2019: nil).

Share capital and funding
Full details of the Group and Company’s share 
capital movements during the year are given in 
note 20 to the financial statements.

Directors and their interests
The following Directors held office in the year:

John Samuel –  
resigned 20 March 2020

Gareth Jones –  
resigned 17 November 2020 

Jonathan Glenn

Shervanthi Homer-Vanniasinkam 

Alan Miller –  
resigned 4 December 2020 

Randeep Singh Grewal –  
resigned 4 December 2020

Daniel Lee –  
appointed 16 November 2020

Directors’ interests in the shares of the 
Company, including family interests, are 
included in the remuneration report on  
pages 58 to 59.

Directors’ indemnity insurance
The Group has maintained insurance 
throughout the year for its Directors and 
officers against the consequences of actions 
brought against them in relation to their duties 
for the Group.

Corporate governance
The corporate governance report is set out on 
pages 52 to 57.

Substantial shareholders 
As at 31 December 2020, shareholders holding 
more than 3% of the share capital of Tissue 
Regenix Group plc were:

Name of
shareholder

Lombard Odier 

IP Group (London)

Mr Richard Griffiths (UK)

Premier Miton Investments (London)

Harwood Capital (London)

Number of
shares

% of voting 
rights

1,109,400,001

960,837,567

711,250,000

709,029,653

487,500,000

15.77

13.66

10.11

10.08

6.93

60

TISSUE REGENIX GROUP PLCANNUAL REPORT AND ACCOUNTS FOR THE YEAR ENDED 31 DECEMBER 2020  
Employment Policies
The Group is committed to keeping employees 
as fully informed as possible regarding the 
Group’s performance and prospects and seeks 
their views, wherever possible, on matters 
which affect them as employees. More 
information can be found in our sustainability 
report on pages 44 to 45.

Auditor
RSM UK Audit LLP have indicated willingness 
to continue in office, in accordance with the 
recommendation of the Audit Committee 
and section 489 of the Companies Act 2006. A 
resolution to reappoint RSM as the Company’s 
Auditor will be proposed at the forthcoming 
Annual General Meeting.

Statement as to disclosure of 
information to the Auditor
The Directors who were in office on the date 
of approval of these financial statements have 
confirmed, that as far as they are aware, there 
is no relevant audit information of which the 
Auditor is unaware. Each of the Directors has 
confirmed that they have taken all the steps 
that they ought to have taken as Directors 
in order to make themselves aware of any 
relevant audit information and to establish that 
it has been communicated to the Auditor.

Financial instruments
Further details of financial risk management 
objectives and policies are set out on pages 38 
to 43 and in note 15 of the financial statements.

Strategic report
The Group has chosen in accordance with 
Companies Act 206 s414C (11) to set out in the 
Group’s strategic report information required 
by Large and Medium-sized Companies and 
Groups (Accounts and Reports) Regulations 
2008, Sch 7 to be contained in the Directors’ 
report in relation to research and development 
and future developments and important 
events affecting the Group since the end of  
the year. 

The Directors Report was approved by the 
Board on 27 April 2021. 

On behalf of the Board

Daniel Lee 
Chief Executive Officer

61

GOVERNANCEThe directors are responsible 
for preparing the Strategic 
Report, the Directors’ Report 
and the financial statements in 
accordance with applicable law 
and regulations.

Company law requires the directors to prepare 
group and company financial statements 
for each financial year. The directors have 
elected under company law to prepare the 
group financial statements in accordance 
with international accounting standards in 
conformity with the requirements of the 
Companies Act 2006 and have elected under 
company law to prepare the company financial 
statements in accordance with international 
accounting standards in conformity with the 
requirements of the Companies Act 2006 and 
applicable law.

The Group and company financial statements 
are required by law and international 
accounting standards, in conformity with 
the requirements of the Companies Act 
2006, to present fairly the financial position 
of the Group, the company and the financial 
performance of the Group. The Companies 
Act 2006, provided in relation to such financial 
statements, references the relevant part of 
that Act to the financial statements that 
gives a true and fair view and references the 
achievement of a fair presentation.

Under company law the directors must not 
approve the financial statements unless they 
are satisfied that they give a true and fair view 
of the state of affairs of the group and the 
company and of the profit or loss of the group 
for that period. 

In preparing each of the group and company 
financial statements, the directors are required 
to:

a.  select suitable accounting policies and then 

apply them consistently

b.  make judgements and accounting 

estimates that are reasonable and prudent

c.  state whether they have been prepared in 
accordance with international accounting 
standards in conformity with the 
requirements of the Companies Act 2006

d.  prepare the financial statements on 
the going concern basis unless it is 
inappropriate to presume that the group 
and the company will continue in business

The directors are responsible for keeping 
adequate accounting records that are 
sufficient to show and explain the group’s and 
the company’s transactions and disclose with 
reasonable accuracy at any time the financial 
position of the group and the company and 
enable them to ensure that the financial 
statements comply with the requirements 
of the Companies Act 2006. They are also 
responsible for safeguarding the assets of 
the group and the company and hence for 
taking reasonable steps for the prevention and 
detection of fraud and other irregularities.

The directors are responsible for the 
maintenance and integrity of the corporate 
and financial information included on the 
Tissue Regenix Group plc website.

Legislation in the United Kingdom governing 
the preparation and dissemination of financial 
statements may differ from legislation in other 
jurisdictions.

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62

TISSUE REGENIX GROUP PLCANNUAL REPORT AND ACCOUNTS FOR THE YEAR ENDED 31 DECEMBER 2020 
 
 
 
 
 
 
 
 
 
 
 
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Opinion
We have audited the financial statements 
of Tissue Regenix Group plc (the ‘parent 
company’) and its subsidiaries (the ‘group’) 
for the year ended 31 December 2020 which 
comprise the Consolidated Statement of 
Comprehensive Income, the Consolidated 
and Parent Company Statement of Financial 
Position, the Consolidated and Parent 
Company Statement of Changes in Equity, the 
Consolidated and Parent Company Statement 
of Cash Flows and notes to the financial 
statements, including significant accounting 
policies. The financial reporting framework 
that has been applied in their preparation is 
applicable law and International Accounting 
Standards in conformity with the requirements 
of the Companies Act 2006 and, as regards 
the parent company financial statements, as 
applied in accordance with the provisions of 
the Companies Act 2006.

In our opinion: 

 ▶ the financial statements give a true and fair 
view of the state of the group’s and of the 
parent company’s affairs as at 31 December 
2020 and of the group’s loss for the year 
then ended;

 ▶ the group financial statements have been 
properly prepared in accordance with 
International Accounting Standards in 
conformity with the requirements of the 
Companies Act 2006;

 ▶ the parent company financial statements 

have been properly prepared in accordance 
with International Accounting Standards 
in conformity with the requirements of 
the Companies Act 2006 and as applied in 
accordance with the Companies Act 2006; 
and

 ▶ the financial statements have been 
prepared in accordance with the 
requirements of the Companies Act 2006.

Basis for opinion
We conducted our audit in accordance with 
International Standards on Auditing (UK) (ISAs 
(UK)) and applicable law. Our responsibilities 
under those standards are further described 
in the Auditor’s responsibilities for the audit 
of the financial statements section of our 

Summary of our audit approach
Key audit matters Group

 ▶ Goodwill impairment

report. We are independent of the group and 
parent company in accordance with the ethical 
requirements that are relevant to our audit of 
the financial statements in the UK, including 
the FRC’s Ethical Standard as applied to SME 
listed entities and we have fulfilled our other 
ethical responsibilities in accordance with 
these requirements. We believe that the audit 
evidence we have obtained is sufficient and 
appropriate to provide a basis for our opinion.

Conclusions relating to  
going concern
In auditing the financial statements, we have 
concluded that the directors’ use of the going 
concern basis of accounting in the preparation 
of the financial statements is appropriate. 
Our evaluation of the directors’ assessment of 
the group’s and parent company’s ability to 
continue to adopt the going concern basis of 
accounting included obtaining and reviewing 
management’s going concern assessment for 
the period to 31 December 2022, assessing the 
results and appropriateness of management’s 
sensitivity testing, reviewing the key terms 
of debt facilities, and reviewing going 
concern disclosures included in the financial 
statements.

We have observed that the group continues to 
experience disruption in the USA due primarily 
to the Coronavirus pandemic and the deferral 
of elective surgery. However, the Group has 
significant cash reserves at 31 December of 
£9.6m following the fundraising in June 2020 
and even in downside scenarios which take 
account of slow sales growth management’s 
forecasts indicate significant cash at the end of 
the forecast period.

Based on the work we have performed, we 
have not identified any material uncertainties 
relating to events or conditions that, 
individually or collectively, may cast significant 
doubt on the group’s or the parent company’s 
ability to continue as a going concern for a 
period of at least twelve months from when 
the financial statements are authorised for 
issue.

Our responsibilities and the responsibilities of 
the directors with respect to going concern are 
described in the relevant sections of this report.

Materiality

Parent Company
 ▶ Impairment of intercompany receivables

Group
 ▶ Overall materiality: £290,000 (2019: £297,000)
 ▶ Performance materiality: £217,000 (2019: £222,000)

Parent Company
 ▶ Overall materiality: £222,000 (2019: £169,000)
 ▶ Performance materiality: £166,000 (2019: £127,000)

Scope

Our audit procedures covered 100% of revenue, 98% of total assets and  
98% of loss before tax.

63

FINANCIAL STATEMENTS  
 
 
 
 
 
 
 
 
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Key audit matters
Key audit matters are those matters that, in our professional judgment, were of most significance 
in our audit of the group and parent company financial statements of the current period and 
include the most significant assessed risks of material misstatement (whether or not due to 
fraud) we identified, including those which had the greatest effect on the overall audit strategy, 
the allocation of resources in the audit and directing the efforts of the engagement team. These 
matters were addressed in the context of our audit of the group and parent company financial 
statements as a whole, and in forming our opinion thereon, and we do not provide a separate 
opinion on these matters.

Goodwill impairment

Key audit matter 
description

How the matter  
was addressed  
in the audit

Key observations

The non-current assets of the CellRight Technologies LLC (“CellRight”) 
cash generating unit (CGU) includes goodwill of £8.6m (after a current year 
impairment charge of £6.1m) and this CGU is subject to annual impairment 
testing. The CellRight CGU is a legal entity in its own right and forms part 
of the Orthopaedics and Dental operating segment. Management have 
disclosed details relating to their impairment test in note 12.

Impairment testing requires management to compare the carrying amount 
of the CGU’s attributable assets and liabilities with the higher of fair value 
less costs of disposal and value in use (the “Recoverable Amount”). Where the 
carrying amount is higher than Recoverable Amount then an impairment 
charge arises. Impairment testing involves a significant degree of judgement 
because management’s determination of value in use is based on a number 
of assumptions, including an assessment of future performance in a high 
growth sector, and the selection of an appropriate discount rate. Any 
recorded impairment charge would most likely have a material impact on 
the financial statements and we therefore considered this matter to be one 
of the matters of most significance in the current year audit. 

Management provided us with an impairment model for the CellRight CGU. 
We performed audit work on this impairment test, which included:

 ▶ Checking the calculation of the impairment charge arising by 

reperforming the comparison of Recoverable Amount with carrying 
amount, including agreeing the carrying amount to the accounting 
records.

 ▶ Using a specialist to check the appropriateness of the method and the 

mathematical calculation of value in use within the model and to obtain 
an independent estimate of an appropriate weighted average cost of 
capital (WACC).

 ▶ Challenging management to support key assumptions within the model, 

particularly forecast revenue growth.

 ▶ Reviewing the disclosures made in the financial statements to ensure 
that they were in accordance with the applicable financial reporting 
framework.

We identified a significant mechanical error in the impairment model 
initially presented by management which reduced the calculation of value 
in use significantly. We also identified that the key assumption within 
the model was future revenue growth and we challenged management 
on whether sector growth rates used previously adequately reflected the 
uncertainty created by the Coronavirus pandemic. In response to these 
findings, management revised their assessment, resulting in an impairment 
charge of £6.1m.

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TISSUE REGENIX GROUP PLCANNUAL REPORT AND ACCOUNTS FOR THE YEAR ENDED 31 DECEMBER 2020  
 
 
 
 
 
 
 
 
Impairment of intercompany receivables (parent company only)

Key audit matter 
description

The parent company has loans due from subsidiary undertakings that are 
currently loss making. The loans are repayable on demand and the subsidiary 
undertakings do not have sufficient liquid assets to make repayment should 
the parent company call in the loans.

One of the most significant matters in the current year audit of the parent 
company is that management are required to calculate an expected credit 
loss (“ECL”) provision in accordance with IFRS9 Financial Instruments. 
The calculation of ECLs involves a significant degree of judgement and 
estimation as management have to make assumptions about future cash 
generation and consider multiple scenarios through which the balances may 
be recovered.

Given the magnitude of the loan balances we considered this matter to be 
one of the matters of most significance in the current year audit.

At the 31 December 2020, the carrying value of amounts due from group 
undertakings amounted to £11.8m after recording an ECL provision of £64.1m 
(see note C2).

How the matter 
was addressed  
in the audit

We obtained management’s calculation of the ECL and the underlying 
calculations prepared to support the carrying value of the balance and 
performed work as follows:

 ▶ Assessed the reasonableness of the scenarios considered by management 

and the probabilities assigned to each.

 ▶ Ensured that the cash flow forecasts used were consistent with the latest 

Board approved forecasts.

 ▶ Recalculated the computation of the ECL.

Key observations

As a result of our work we concurred with management’s calculated ECL and 
we ensured that the key estimates within the calculation were adequately 
disclosed within the critical estimates at note C2.

Our application of materiality
When establishing our overall audit strategy, we set certain thresholds which help us to determine 
the nature, timing and extent of our audit procedures. When evaluating whether the effects of 
misstatements, both individually and on the financial statements as a whole, could reasonably 
influence the economic decisions of the users we take into account the qualitative nature and the 
size of the misstatements. Based on our professional judgement, we determined materiality as 
follows:

Overall materiality

Basis for determining 
overall materiality

Rationale for 
benchmark applied

Performance 
materiality
Basis for determining 
performance 
materiality
Reporting of 
misstatements to  
the Audit Committee

Group

Parent company

£290,000 (2019: £297,000)

£222,000 (2019: £169,000)

2.3% of total revenue

Revenue selected given shareholder 
focus on revenue growth. The group 
is still in relatively early phase of 
development and revenue growth is 
critical to reducing operating losses.

0.6% of net assets. The percentage 
applied to the benchmark has 
been restricted for the purpose 
of calculating an appropriate 
component materiality.

Net assets selected as the parent 
company is purely a holding 
company and no income statement 
is presented.

£217,000 (2019: £222,000)

£166,000 (2019: £127,000)

75% of overall materiality

75% of overall materiality

Misstatements in excess of 
£15,000 and misstatements below 
that threshold that, in our view, 
warranted reporting on qualitative 
grounds. 

Misstatements in excess of 
£11,000 and misstatements below 
that threshold that, in our view, 
warranted reporting on qualitative 
grounds. 

65

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An overview of the scope of our audit
The group consists of 11 components, located in the United Kingdom, USA and Germany. 

The coverage achieved by our audit procedures was:

Full scope audit

Specific audit procedures 

Total

Number of 
components

Revenue Total assets

Loss  
before tax

8

2

10

84%

16%

100%

98%

–%

98%

96%

2%

98%

Specific audit procedures were performed 
on two components: one contained the 
Borrowings of the group and related finance 
costs and the other contained significant 
revenue. Analytical procedures at group 
level were performed for the remaining 1 
component.

Of the above, specific audit procedures for the 
component containing significant revenue 
were undertaken by component auditors. 

Other information
The other information comprises the 
information included in the annual report, 
other than the financial statements and 
our auditor’s report thereon. The directors 
are responsible for the other information 
contained within the annual report. Our 
opinion on the financial statements does not 
cover the other information and, except to the 
extent otherwise explicitly stated in our report, 
we do not express any form of assurance 
conclusion thereon. 

Our responsibility is to read the other 
information and, in doing so, consider 
whether the other information is materially 
inconsistent with the financial statements 
or our knowledge obtained in the course 
of the audit or otherwise appears to be 
materially misstated. If we identify such 
material inconsistencies or apparent 
material misstatements, we are required to 
determine whether this gives rise to a material 
misstatement in the financial statements 
themselves. If, based on the work we have 
performed, we conclude that there is a material 
misstatement of this other information, we are 
required to report that fact. 

We have nothing to report in this regard.

Opinions on other matters 
prescribed by the Companies 
Act 2006
In our opinion, based on the work undertaken 
in the course of the audit:

 ▶ the information given in the Strategic 

Report and the Directors’ Report for the 
financial year for which the financial 
statements are prepared is consistent with 
the financial statements; and

 ▶ the Strategic Report and the Directors’ 

Report have been prepared in accordance 
with applicable legal requirements.

Matters on which we are 
required to report by 
exception
In the light of the knowledge and 
understanding of the group and the parent 
company and their environment obtained in 
the course of the audit, we have not identified 
material misstatements in the Strategic Report 
or the Directors’ Report.

We have nothing to report in respect of the 
following matters in relation to which the 
Companies Act 2006 requires us to report to 
you if, in our opinion:

 ▶ adequate accounting records have not been 

kept by the parent company, or returns 
adequate for our audit have not been 
received from branches not visited by us; or

 ▶ the parent company financial statements 
are not in agreement with the accounting 
records and returns; or

 ▶ certain disclosures of directors’ 

remuneration specified by law are not 
made; or

 ▶ we have not received all the information and 

explanations we require for our audit.

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TISSUE REGENIX GROUP PLCANNUAL REPORT AND ACCOUNTS FOR THE YEAR ENDED 31 DECEMBER 2020  
 
 
 
 
 
 
 
 
Responsibilities of directors
As explained more fully in the Statement of 
Director’s Responsibilities, the directors are 
responsible for the preparation of the financial 
statements and for being satisfied that they 
give a true and fair view, and for such internal 
control as the directors determine is necessary 
to enable the preparation of financial 
statements that are free from material 
misstatement, whether due to fraud or error.

In preparing the financial statements, the 
directors are responsible for assessing the 
group’s and the parent company’s ability 
to continue as a going concern, disclosing, 
as applicable, matters related to going 
concern and using the going concern basis of 
accounting unless the directors either intend 
to liquidate the group or the parent company 
or to cease operations, or have no realistic 
alternative but to do so.

Auditor’s responsibilities 
for the audit of the financial 
statements
Our objectives are to obtain reasonable 
assurance about whether the financial 
statements as a whole are free from material 
misstatement, whether due to fraud or error, 
and to issue an auditor’s report that includes 
our opinion. Reasonable assurance is a high 
level of assurance, but is not a guarantee that 
an audit conducted in accordance with ISAs 
(UK) will always detect a material misstatement 
when it exists. Misstatements can arise from 
fraud or error and are considered material if, 
individually or in the aggregate, they could 
reasonably be expected to influence the 
economic decisions of users taken on the basis 
of these financial statements.

The extent to which the audit 
was considered capable 
of detecting irregularities, 
including fraud
Irregularities are instances of non-compliance 
with laws and regulations. The objectives of 
our audit are to obtain sufficient appropriate 
audit evidence regarding compliance with 
laws and regulations that have a direct effect 
on the determination of material amounts 
and disclosures in the financial statements, 
to perform audit procedures to help identify 
instances of non-compliance with other laws 
and regulations that may have a material effect 
on the financial statements, and to respond 
appropriately to identified or suspected 
non-compliance with laws and regulations 
identified during the audit. 

In relation to fraud, the objectives of our audit 
are to identify and assess the risk of material 
misstatement of the financial statements 
due to fraud, to obtain sufficient appropriate 
audit evidence regarding the assessed risks of 
material misstatement due to fraud through 
designing and implementing appropriate 
responses and to respond appropriately to 
fraud or suspected fraud identified during the 
audit. 

However, it is the primary responsibility of 
management, with the oversight of those 
charged with governance, to ensure that 
the entity’s operations are conducted in 
accordance with the provisions of laws and 
regulations and for the prevention and 
detection of fraud.

In identifying and assessing risks of material 
misstatement in respect of irregularities, 
including fraud, the group audit engagement 
team: 

 ▶ obtained an understanding of the nature 
of the industry and sector, including the 
legal and regulatory frameworks that the 
group and parent company operate in and 
how the group and parent company are 
complying with the legal and regulatory 
frameworks;

 ▶ inquired of management, and those 

charged with governance, about their own 
identification and assessment of the risks of 
irregularities, including any known actual, 
suspected or alleged instances of fraud;

 ▶ discussed matters about non-compliance 
with laws and regulations and how fraud 
might occur including assessment of how 
and where the financial statements may be 
susceptible to fraud.

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The most significant laws and regulations were determined as follows:

Legislation / 
Regulation

Additional audit procedures performed by the  
Group audit engagement team included:

IFRS and Companies 
Act 2006

Tax compliance 
regulations

 ▶ Review of the financial statement disclosures and testing to supporting 

documentation;

 ▶ Completion of disclosure checklists to identify areas of non-compliance.

 ▶ Inspection of advice received from internal and external tax advisors

 ▶ Input from a tax specialist was obtained regarding management’s 

calculation of Research and Development tax credit claims made under 
the UK SME scheme during the year.

FDA Medical device 
regulations in the  
USA

 ▶ Inquiry of management and those charged with governance as to 

whether the group is in compliance with these laws and regulations and 
inspection of correspondence with the regulatory authority.

The areas that we identified as being susceptible to material misstatement due to fraud were:

Risk

Audit procedures performed by the audit engagement team:

Revenue  
recognition

 ▶ Testing a sample of revenue transactions, either side of the balance sheet 
date, to determine whether they have been recognised in the correct 
financial period; and

 ▶ Testing of revenue recognised on a Bill and Hold basis to ensure 

compliance with the Group’s stated accounting policy in this area 
including: 

 − confirming existence by substantiating outstanding invoices at the 

year-end to subsequent cash receipt, and 

 − checking cut-off by ensuring that revenue for a sample of these 

transactions were recorded in the correct period by confirming key 
terms of the sale to the customer purchase order and by checking that 
the related inventory movement was recorded in the same period.

Management  
override of controls 

 ▶ Testing the appropriateness of journal entries and other adjustments; 

 ▶ Assessing whether the judgements made in making accounting 

estimates are indicative of a potential bias; and

 ▶ Evaluating the business rationale of any significant transactions that are 

unusual or outside the normal course of business.

A further description of our responsibilities for the audit of the financial statements is located on 
the Financial Reporting Council’s website at: http://www.frc.org.uk/auditorsresponsibilities. This 
description forms part of our auditor’s report.

Use of our report 
This report is made solely to the company’s members, as a body, in accordance with Chapter 3 of 
Part 16 of the Companies Act 2006. Our audit work has been undertaken so that we might state 
to the company’s members those matters we are required to state to them in an auditor’s report 
and for no other purpose. To the fullest extent permitted by law, we do not accept or assume 
responsibility to anyone other than the company and the company’s members as a body, for our 
audit work, for this report, or for the opinions we have formed.

Michael Thornton (Senior Statutory Auditor)
For and on behalf of RSM UK Audit LLP, Statutory Auditor 
Chartered Accountants
Central Square, Fifth Floor
29 Wellington Street
Leeds
LS1 4DL
27 April 2021

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TISSUE REGENIX GROUP PLCANNUAL REPORT AND ACCOUNTS FOR THE YEAR ENDED 31 DECEMBER 2020  
 
 
 
 
 
 
 
 
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2
0
2

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1
3

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D
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A
D
L
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I

Revenue

Cost of sales

Gross profit

Administrative expenses before exceptional items

Exceptional items

Total administrative expenses

Grant Income

Operating loss

Finance income

Finance charges

Loss before taxation

Tax

Loss for year

Attributable to:

Equity holders of the parent

Non-controlling interests

Other comprehensive income:

Foreign currency translation differences – foreign operations

Total comprehensive expense for the year

Attributable to:

Equity holders of the parent

Non-controlling interests

Loss per share

Notes

3

3

4

4

6

7

8

9

22

22

2020
£000

12,829

(6,933)

5,896

(10,066)

(6,483)

(16,549)

855

2019
£000

13,033

(7,014)

6,019

(13,198)

(21)

(13,219)

-

(9,798)

(7,200)

2

(445)

(10,241)

533

(9,708)

(9,709)

1

(9,708)

(764)

(10,472)

(10,473)

1

(10,472)

17

(477)

(7,660)

554

(7,106)

(6,973)

(133)

(7,106)

(724)

(7,830)

(7,697)

(133)

(7,830)

Basic and diluted loss attributable to equity holders of parent

9

(0.22)p

(0.60)p

The loss for the period arises from the Group’s continuing operations.

69

FINANCIAL STATEMENTS 
 
 
 
 
 
 
 
 
 
Assets

Non-current assets

Property, plant and equipment

Right of use assets

Intangible assets

Total non-current assets

Current assets

Inventory

Trade and other receivables

Corporation tax receivable

Cash and cash equivalents

Total current assets

Total assets

Liabilities

Non-current liabilities

Borrowings

Deferred tax

Lease liability

Total non-current liabilities

Current liabilities

Trade and other payables

Borrowings

Lease liability

Total current liabilities

Total liabilities

Net assets

Equity and reserves

Share capital

Share premium

Merger reserve

Reverse acquisition reserve

Reserve for own shares

Share based payment reserve

Retained earnings deficit

Equity attributable to equity holders of parent

Non-controlling interests

Total equity

Notes

2020
£000

2019
£000

10

11

12

13

14

15

17

18

19

16

19

20

20

20

20

20

21

20

22

3,252

2,458

10,931

16,641

7,072

2,643

825

9,550

20,090

36,731

(2,790)

(560)

(2,271)

(5,621)

2,357

–

17,999

20,356

4,185

2,539

1,035

2,380

10,139

30,495

 (2,115)

(670)

–

(2,785)

(3,007)

(2,944)

–

(256)

(3,263)

(8,884)

27,847

11,720

94,290

10,884

(7,148)

(831)

955

(171)

–

(3,115)

(5,900)

24,595

5,859

86,399

10,884

(7,148)

(831)

983

(81,409)

(70,936)

28,461

(614)

27,847

25,210

(615)

24,595

The consolidated financial statements were approved by the Board of Directors on 27 April 2021 
and were signed on its behalf by:

Daniel Lee
Chief Executive Officer 

Company number: 05969271

1
3

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A
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L
O
S
N
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C

I

70

TISSUE REGENIX GROUP PLCANNUAL REPORT AND ACCOUNTS FOR THE YEAR ENDED 31 DECEMBER 2020 
 
 
 
 
 
 
0
2
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L
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I

At 
31 December 
2018

Loss for the 
period

Other 
comprehensive 
income

Loss and total 
comprehensive 
expense for the 
period

Contributions 
by and 
distributions 
to owners

Exercise of 
share options

Share based 
payments

At 
31 December 
2019

Loss for the 
period

Other 
comprehensive 
expense

Loss and total 
comprehensive 
expense for the 
period

Contributions 
by and 
distributions 
to owners

Attributable to equity holders of parent

l

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5,859 86,398 10,884 (7,148)

(831)

1,129 (63,239)

33,052

(482)

32,570

–

–

–

–

–

–

–

–

1

–

–

–

–

–

–

–

–

–

–

–

–

–

–

–

–

–

–

(6,973)

(6,973)

(133)

(7,106)

(724)

(724)

–

(724)

–

(7,697)

(7,697)

(133)

(7,830)

–

(146)

–

–

1

(146)

–

–

1

(146)

5,859 86,399 10,884 (7,148)

(831)

983 (70,936)

25,210

(615)

24,595

–

–

–

–

–

–

–

1

(899)

–

–

–

–

–

–

–

–

–

–

–

–

–

–

–

–

–

–

–

–

–

(9,709)

(9,709)

1

(9,708)

(764)

(764)

–

(764)

–

(10,473)

(10,473)

1

(10,472)

–

–

–

14,650

–

14,650

–

–

–

–

–

(28)

–

–

–

(899)

1

(28)

–

–

–

(899)

1

(28)

11,720 94,290 10,884 (7,148)

(831)

955 (81,409)

28,461

(614)

27,847

71

Issue of shares

5,860

8,790

Cost of issue of 
new Equity

Exercise of 
share options

Share based 
payments

At 
31 December 
2020

FINANCIAL STATEMENTS 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
0
2
0
2

S
W
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1
3

Operating activities

Loss before taxation

Adjustment for:

Notes

2020
£000

2019
£000

(10,241)

(7,660)

Depreciation of property, plant. equipment and right of use 
asset

Amortisation of intangible assets

Impairment of intangible assets and property,  
plant and equipment

10

12

10/12

Share based payments

Interest receivable

Interest payable

r
o
F

Operating cash outflow before working capital movements

(Increase) in inventory

(Increase)/decrease in trade and other receivables

(Decrease) in trade and other payables

Cash outflows from operations

Research & development tax credit received

Net cash outflow from operations

Investing activities

Interest received

Purchases of property, plant and equipment

Capitalised development expenditure

Net cash outflow from investing activities

Financing activities

Interest paid

Proceeds from exercise of share options

Gross proceeds from issue of shares

Cost of issue of equity

Proceeds from new loans

Repayment of loans

Lease liability payments

Lease interest payments

Net cash inflow from financing activities

Increase/(decrease) in cash and cash equivalents

Foreign exchange translation movement

Cash and cash equivalents at start of period

Cash and cash equivalents at end of period

21

6

7

13

14

16

6

10

12

7

19

192

570

6,130

(28)

(2)

445

(2,934)

(2,887)

(11)

(46)

(5,878)

649

(5,229)

2

(1,158)

(215)

(1,371)

(245)

2

14,650

(899)

504

–

(41)

(200)

13,771

7,171

(1)

2,380

9,550

476

570

1,311

(146)

(17)

477

(4,989)

(1,855)

1,076

(1,567)

(7,335)

653

(6,682)

17

(438)

(213)

(634)

(384)

1

–

–

6,479

(4,193)

–

–

1,903

(5,413)

(23)

7,816

2,380

F
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E
T
A
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O
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N
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I

72

TISSUE REGENIX GROUP PLCANNUAL REPORT AND ACCOUNTS FOR THE YEAR ENDED 31 DECEMBER 2020 
 
 
 
 
 
 
 
 
 
 
E
H
T
O
T
S
E
T
O
N

0
2
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I

I

1) Basis of preparation
The financial statements of Tissue Regenix 
Group plc are audited consolidated financial 
statements for the year ended 31 December 
2020. These include audited comparatives for 
the year ended 31 December 2019.

The consolidated financial statements are 
prepared in accordance with international 
accounting standards in conformity with the 
Companies Act 2006 (‘IFRS’).

The Company is incorporated and domiciled in 
the United Kingdom and its registered number 
is 05969271. The address of the registered 
office is Unit 3 Phoenix Court, Lotherton 
Way, Garforth LS25 2GY. The Company was 
incorporated on 17 October 2006. The principal 
activity of Tissue Regenix Group is to develop, 
manufacture and commercialise biological 
medical devices.

The Group financial statements consolidate 
the financial statements of Tissue Regenix 
Group plc and the entities it controls, being its 
subsidiaries and its joint venture interest.

Going concern
The Group financial statements have been 
prepared on a going concern basis based on 
cash flow projections approved by the Board 
for the Group for the period to 31 December 
2022 (the “Cash Flow Projections”). 

Funding requirements are reviewed on a 
regular basis by the Group’s Chief Executive 
Officer and Chief Financial Officer and are 
reported to the Board at each Board meeting, 
as well as on an ad hoc basis, if requested. The 
Cash Flow Projections show that the group will 
continue to consume cash over the forecast 
period. Until sufficient cash is generated from 
its operations, the Group remains reliant on 
cash reserves of £9.6m at 31 December 2020 
and the ongoing support of MidCap Financial 
Trust (“MidCap”)(borrowings of £2.8m at 31 
December 2020) to meet its working capital 
requirements, capital investment programme 
and other financial commitments. 

The COVID-19 pandemic has affected most 
businesses during 2020. As a result of the 
reprioritisation of healthcare professionals 
during this time, there has been a decline 
in elective procedures undertaken across a 
number of medical specialities that use our 
products. Given the uncertainty around the 
level and duration of disruption from COVID-19, 
it is difficult to determine how long the current 
situation may last, and the time taken to 
catch-up any postponed surgical procedures 
thereafter. 

However, the Board, in compiling the Cash 
Flow Projections, has considered a downside 
scenario regarding the effect of reduced and 
delayed revenues due to COVID-19 and, has 
undertaken market soundings regarding the 
likely timeframe for the recommencement 
of procedures. It has concluded that there 

will not be a significant long-lasting impact 
on the capability of the business to carry 
out its commercial activities. The Cash Flow 
Projections prepared by the board, including 
the downside scenario, indicate that the Group 
will still have cash reserves at the end of the 
forecast period.

The Group’s Cash Flow Projections also 
assume that the MidCap facilities are available 
throughout the forecast period as they are 
repayable in 2024. The availability of these 
facilities is dependent upon compliance with a 
rolling twelve month revenue covenant which 
is measured on a monthly basis. The Cash 
Flow Projections indicate compliance with this 
covenant throughout the forecast period. The 
scenario reflecting very low growth indicates 
that this covenant may be breached in the 
second half of 2022. That scenario also shows 
that the MidCap facility could be repaid from 
cash reserves in the event that repayment was 
demanded by MidCap.

In summary, the Directors have considered 
their obligations in relation to the assessment 
of the going concern basis for preparation of 
the financial statements of the Group and 
have reviewed the Cash Flow Projections. 
On the basis of their assessment, they have 
concluded that the going concern basis 
remains appropriate for use in these financial 
statements.

2) Significant accounting 
policies 

Basis of Consolidation
Subsidiaries are entities controlled by the 
Group. The Group controls an entity when 
it is exposed to, or has rights to, variable 
returns from its involvement with the entity 
and has the ability to affect those returns 
through its power over the entity. In assessing 
control, the Group takes into consideration 
potential voting rights. The acquisition date 
is the date on which control is transferred 
to the acquirer. The financial statements of 
subsidiaries are included in the consolidated 
financial statements from the date that control 
commences until the date that control ceases. 
Losses applicable to the non-controlling 
interests in a subsidiary are allocated to the 
non-controlling interests even if doing so 
causes the non-controlling interests to have a 
deficit balance.

Controlled Joint Venture
Tissue Regenix Group entered a joint venture 
in January 2016 establishing GBM-V GmbH, a 
company in Germany.

The results for this entity are consolidated 
within these financial statements because 
the Group controls the majority of the voting 
rights.

73

FINANCIAL STATEMENTS 
 
  
 
 
 
 
 
 
 
D
E
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2) Significant accounting 
policies CONTINUED

Transactions eliminated on consolidation
Intra-group balances and transactions, and 
any unrealised income and expenses arising 
from intra-group transactions, are eliminated. 
Unrealised gains arising from transactions with 
equity-accounted investees are eliminated 
against the investment to the extent of the 
Group’s interest in the investee. Unrealised 
losses are eliminated in the same way as 
unrealised gains, but only to the extent that 
there is no evidence of impairment.

Goodwill
Goodwill arising on the acquisition of a 
subsidiary undertaking is the difference 
between the fair value of the consideration 
payable and the fair value of the identifiable 
assets, liabilities and contingent liabilities 
acquired. Goodwill is tested annually for 
impairment as described below.

Revenue
Revenue is measured as the fair value of the 
consideration received or receivable in the 
normal course of business, net of discounts, 
VAT and other sales related taxes and is 
recognised to the extent that it is probable that 
the economic benefits associated with the 
transaction will flow in to the Company, which 
usually coincides with the despatch of goods

Bill and hold sales

The Group has bill-and-hold arrangements 
with customers, and this revenue is 
recognised when the company considers that 
performance obligations have been met and 
they meet the following criteria:

 ▶ The reason for the bill-and-hold 

arrangement must be substantive (usually 
the arrangement has been requested by 
the customer to facilitate their shipping 
arrangements)

 ▶ The product must be identified separately 
as belonging to the customer (that is, it 
cannot be used to satisfy other orders)

 ▶ The product must be ready for physical 

transfer to the customer

 ▶ The Group cannot have the ability to use the 
product, or to direct it to another customer

Grant Income

Grant income is recognised as earned based 
on contractual conditions and is presented as 
Grant income on the face of the Statement of 
comprehensive income.

Foreign Currencies
The individual financial statements of each 
Group entity are presented in the currency of 
the primary economic environment in which 
the entity operates (its functional currency). 
For the purposes of the consolidated financial 
statements, the results and the financial 
position of each Group entity are expressed in 

Pounds Sterling, which is the functional and 
presentational currency of the Company and 
consolidated financial statements.

Exchange differences arising on transaction 
and monetary items in the financial 
statements of individual entities are recorded 
as a profit or loss within the income statement.

The assets and liabilities of foreign operations 
are translated into sterling using exchange 
rates at the balance sheet date. The 
components of shareholders’ equity are stated 
at historical value. An average exchange rate 
for the period is used to translate the results 
and cash flows of foreign operations.

Exchange differences arising on translating the 
results and net assets of foreign operations are 
recorded in other comprehensive incomes and 
taken to the translation reserve in equity until 
the disposal of the investment.

Research and Development
Research costs are charged to profit and 
loss as they are incurred. An intangible asset 
arising from development expenditure on an 
individual project is recognised only when all of 
the following criteria can be demonstrated:

 ▶ It is technically feasible to complete the 

product and the management is satisfied 
that appropriate regulatory hurdles have 
been, or will be achieved

 ▶ Management intends to complete the 

product and use or sell it

 ▶ There is an ability to use or sell the product

 ▶ It can be demonstrated how the product 
will generate probable future economic 
benefits

 ▶ Adequate technical, financial and other 
resources are available to complete the 
development, use or sell the product

 ▶ Expenditure attributable to the product can 

be reliably measured

Such intangible assets are amortised on a 
straight-line basis, from the point at which 
the assets are ready for use over the period of 
the expected benefit, and are reviewed for an 
indication of impairment at each reporting 
date. Other development costs are charged 
against profit or loss as incurred since the 
criteria for capitalisation are not met.

The costs of an internally generated intangible 
asset comprise all directly attributable costs 
necessary to create, produce and prepare 
the asset to be capable of operating in the 
manner intended by management. Directly 
attributable costs include employee costs 
incurred on technical development, testing 
and certification, materials consumed and any 
relevant third party cost. The costs of internally 
generated developments are recognised 
as intangible assets and are subsequently 
measured in the same way as externally 
acquired intangible assets. However, until 
completion of the development project, the 
assets are subject to impairment testing only.

0
2
0
2

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e
D

1
3

d
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T
O
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74

TISSUE REGENIX GROUP PLCANNUAL REPORT AND ACCOUNTS FOR THE YEAR ENDED 31 DECEMBER 2020 
 
  
 
 
 
 
 
 
 
2) Significant accounting 
policies CONTINUED
Exceptional Items
Items which are significant by virtue of their 
size or nature and/or which are considered 
non-recurring are classified as an exceptional 
operating item. Such items are included 
within the appropriate consolidated income 
statement category but are highlighted 
separately. Exceptional operating items are 
excluded from the profit measures used by the 
Directors to monitor underlying performance.

Inventories
Inventories are recognised at the lower of cost 
and net realisable value. Cost is determined 
using the first in, first out method and 
represents the purchase cost, including 
transport, for raw materials, together with 
a proportion of manufacturing overheads 
based on normal levels of activity for work 
in progress and finished goods. Appropriate 
provisions for estimated irrecoverable amounts 
are recognised in the income statement when 
there is objective evidence that the assets are 
impaired.

Property, Plant, Equipment and Right of Use 
assets
Property, plant and equipment assets are 
stated at their historical cost of acquisition less 
any provision for depreciation or impairment.

Depreciation is provided on all property, plant 
and equipment assets at rates calculated to 
write each asset down to its estimated residual 
value evenly over its expected useful life, as 
follows:

Buildings 

Laboratory equipment 

Computer equipment 

Fixtures and fittings 

Land is not depreciated.

over 39 years

over 5–7 years

over 3 years

over 5 years 

A Right of Use asset is recognised at 
commencement of the lease and initially 
measured at the amount of the lease liability, 
plus any incremental costs of obtaining 
the lease and any lease payments made 
at or before the leased asset is available 
for use by the Group. The Right of Use 
asset is subsequently measured at cost 
less accumulated depreciation and any 
accumulated impairment losses. Right of Use 
assets are depreciated on a straight-line basis 
over the lease term (39 years).

Intangible Assets
Intangible assets are stated at fair value at 
acquisition. They are subsequently held at 
cost less any provision for impairment or 
amortisation. Intangible assets are amortised 
through administrative expenses within the 
income statement over their expected useful 
life as follows:

Trademarks 

Customer relationships 

Process & IT technology 

Supplier agreements 

over 5 years

over 10 years

over 10 years

over 5 years

Impairment of Property, Plant and 
Equipment, Intangible and Right of Use 
assets
At each reporting date, the Group reviews the 
carrying amounts of its property, plant and 
equipment and intangible assets to determine 
whether there is any indication that those 
assets have suffered an impairment loss. If any 
such indication exists, the recoverable amount 
of the asset is estimated in order to determine 
the extent of the impairment loss (if any). For 
the purposes of assessing impairment, assets 
are grouped at the lowest levels for which 
there are separately identifiable cash flows 
(cash generating units).

Discounted cash flow valuation techniques 
are generally applied for assessing recoverable 
amounts using Board approved five-year 
forward- looking cash flow projections and 
terminal value estimates, together with 
discount rates appropriate to the risk of the 
related cash generating units.

If the recoverable amount of an asset is 
estimated to be less than its carrying amount, 
the carrying amount of the asset is reduced to 
its recoverable amount. An impairment loss is 
recognised as an expense immediately.

Share Based Payments

Share options

Equity settled share-based payment 
transactions are measured with reference to 
the fair value at the date of grant, recognised 
on a straight line basis over the vesting period, 
based on the Company’s estimate of shares 
that will eventually vest. Fair value is measured 
using a binomial valuation model.

At each reporting date before vesting, the 
cumulative expense is calculated, representing 
the extent to which the vesting period has 
expired and management’s best estimate 
of the achievement or otherwise of non-
market conditions and the number of equity 
instruments that will ultimately vest. The 
movement in cumulative expense since the 
previous reporting date is recognised in the 
statement of comprehensive income, with a 
corresponding entry in equity.

Jointly held shares

Where an employee acquires an interest in 
shares in the Company jointly with the Tissue 
Regenix Employee Share Trust, the fair value of 
the option at the purchase date is recognised 
on a straight-line basis over the vesting period. 
The fair value benefit is measured using a 
binomial valuation model, taking into account 
the terms and conditions upon which the 
jointly owned shares were purchased.

75

FINANCIAL STATEMENTSD
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2) Significant accounting 
policies CONTINUED

Financial Assets and Liabilities

Trade and other receivables

Trade and other receivables do not carry any 
interest and are initially recognised at fair 
value. They are subsequently measured at 
amortised cost using the effective interest rate 
method, less any provision for impairment.

An expected credit loss (‘ECL’) model, as 
introduced under IFRS 9, broadens the 
information that an entity is required to 
consider when determining its expectations of 
impairment. Under this model, expectations 
of future events must be taken into account 
and this will result in the earlier recognition of 
larger impairments against trade and other 
receivables.

In applying the ECL model the company 
considered the probability of a default 
occurring over the contractual life of its trade 
receivables balances on initial recognition of 
those assets.

Impairment provisions are recognised for the 
group as follows, representing the expected 
credit losses over the contracted life of these 
balances.

Not overdue 

0% of aged receivables

0 to 3 months overdue  0% of aged receivables

to 4 months overdue  25% of aged receivables

to 5 months overdue  50% of aged receivables

Over 5 months 
overdue

100% of aged receivables 

Trade and other payables

Trade and other payables are not interest 
bearing and are initially recognised at fair 
value. They are subsequently measured at 
amortised cost using the effective interest 
method.

Borrowings

Borrowings are interest bearing and are 
initially recognised at fair value less the 
directly attributable costs of issue. They are 
subsequently measured at amortised cost 
using the effective interest method.

Cash and cash equivalents

Cash and cash equivalents comprise cash at 
hand and deposits on a term of not greater 
than six months.

Share capital

Ordinary shares are classified as equity. 
Incremental costs directly attributable to the 
issue of new shares or options are shown in 
equity as a deduction.

Leases
On commencement of a contract which gives 
the Group the right to use assets for a period 
of time in exchange for consideration, the 

Group recognises a right of use asset and a 
lease liability unless the lease qualifies as a 
‘short-term’ lease (term is 12 months or less 
with no option to purchase the lease asset) or a 
‘low-value’ lease (where the underlying asset is 
£4,000 or less when new).

The lease liability is initially measured at the 
present value of the lease payments during 
the lease term discounted using the interest 
rate implicit in the lease, or the incremental 
borrowing rate if the interest rate implicit in 
the lease cannot be readily determined. The 
lease term is the non cancellable period of the 
lease plus extension periods that the Group is 
reasonably certain to exercise and termination 
periods that the Group is reasonably certain 
not to exercise. Lease payments include fixed 
payments, less any lease incentives receivable, 
variable lease payments dependent on an index 
or a rate and any residual value guarantees.

The lease liability is subsequently increased 
for a constant periodic rate of interest on the 
remaining balance of the lease liability and 
reduced for lease payments. Interest on the 
lease liability is recognised in profit or loss. 
Variable lease payments not included in the 
measurement of the lease liability as they 
are not dependent on an index or rate, are 
recognised in profit or loss in the period in 
which the event or condition that triggers 
those payments occurs.

Taxation
Tax on the profit or loss for the year comprises 
current and deferred tax. Tax is recognised in 
the profit and loss account except to the extent 
that it relates to items recognised directly in 
equity or other comprehensive income, in 
which case it is recognised directly in equity or 
other comprehensive income.

Current tax is the expected tax payable or 
receivable on the taxable income or loss for the 
year, using tax rates enacted or substantively 
enacted at the balance sheet date, and any 
adjustment to tax payable in respect of 
previous years.

Deferred tax is provided on temporary 
differences between the carrying amounts 
of assets and liabilities for financial reporting 
purposes and the amounts used for taxation 
purposes. The following temporary differences 
are not provided for: the initial recognition 
of goodwill; the initial recognition of assets 
or liabilities that affect neither accounting 
nor taxable profit other than in a business 
combination, and differences relating to 
investments in subsidiaries to the extent 
that they will probably not reverse in the 
foreseeable future. The amount of deferred 
tax provided is based on the expected manner 
of realisation or settlement of the carrying 
amount of assets and liabilities, using tax 
rates enacted or substantively enacted at the 
balance sheet date.

0
2
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2

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3

d
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M
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T
A
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A
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A
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F

I

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E
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T
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76

TISSUE REGENIX GROUP PLCANNUAL REPORT AND ACCOUNTS FOR THE YEAR ENDED 31 DECEMBER 2020 
 
  
 
 
 
 
 
 
 
2) Significant accounting 
policies CONTINUED
Critical Accounting Estimates  
and Areas of Judgement
Estimates and judgements are continually 
evaluated and are based on historical 
experience and other factors, including 
expectations of future events that are believed 
to be reasonable under the circumstances. 
Actual results may differ from these estimates. 
The estimates and judgements that have 
the most significant effects on the carrying 
amounts of the assets and liabilities in the 
financial information are discussed below:

Judgements 

Leases

As disclosed in note 19, the Group recorded 
a lease liability during the year in respect of 
property adjacent to the owned facility at San 
Antonio, Texas. This lease includes the option 
to purchase the facility within 60 months of 
lease commencement for a fixed sum. The 
Directors have assumed that this option will 
be exercised in calculating the lease liability 
and the corresponding right of use asset on 
the basis that they are reasonably certain to 
exercise the option as the property is adjacent 
to the currently owned facility and there will be 
significant investment in fitting out the facility 
to a very high specification for the purpose 
of manufacturing the group’s products. The 
assumption that the option will be exercised is 
considered to be a critical judgment given that 
there is no absolute certainty that the option 
will be exercised. 

Grant Income 

As described in note 4, the Group received 
loans during the year totalling £815,000 under 
the US Government’s Paycheck Protection 
Program (“PPP”). These loans may be forgiven 
if used for permitted purposes. The Directors 
believe that they have fulfilled all of the 
necessary conditions and have commenced 
the process of applying for forgiveness. The 
forgiveness of the loan has been recorded 
within these financial statements as Grant 
Income, which is considered to be a critical 
judgement as there remains some uncertainty 
around the forgiveness process and outcome.

Estimates 

Impairment testing of non-current assets

At each reporting date the Directors review the 
carrying amount of the Group’s non-current 
assets to determine whether there has been 
any indication that those assets have suffered 
an impairment loss. In the current year, the 
Group recognised no impairment, other than 
in respect of the annual goodwill impairment 
testing as described below  

(2019, an impairment charge of £972k against 
intangible assets and £339k against property, 
plant and equipment). In accordance with 
IFRS, management have performed an annual 
impairment test of the goodwill relating to 
CellRight Technologies LLC and an impairment 
charge of £6,130k has been recognised 
(2019:nil), further details are provided in note 12. 
By its very nature, impairment testing involves 
a high degree of estimation uncertainty due to 
the extent that assumptions have to be made 

regarding likely future trading performance.

New accounting standards and amendments 
adopted in the year

During the year, the Company adopted no new 
standards effective from the 1st January 2020. 
The Company has not adopted any new or 
amended standards early.

Impact of other new International Financial 
Reporting Standards

The following other new standards and 
amended standards, none of which have 
had a material impact on these financial 
statements, are mandatory and relevant to the 
Group for the first time for the financial period 
commencing 1 January 2020:

Amendments to References to the Conceptual 
Framework in IFRS Standards

Definition of a Business (Amendments to  
IFRS 3)

Definition of Material (Amendments to IAS 1 
and IAS 8)

Interest Rate Benchmark Reform 
(Amendments to IFRS 9, IAS 39, IFRS 16, IFRS 4 
and IFRS 7)

Standards, Amendments, Improvements & 
Interpretations issued but not yet effective

At the date of authorisation of these financial 
statements the following standards and 
interpretations, which have not been applied 
in these financial statements, and which are 
considered potentially relevant, were in issue 
but not yet effective:

Applying IFRS 9 ‘Financial Instruments’ with 
IFRS 4 ‘Insurance Contracts’ (Amendments to 
IFRS 4)

Amendments to IFRS 9, IAS 39, IFRS 7, IFRS 4 
and IFRS 16 Interest Rate Benchmark Reform 
– Phase 2 

Covid-19-Related Rent Concessions 
(Amendment to IFRS 16)

The Directors anticipate that the adoption 
of the amendments to standards in future 
periods will have no material impact on the 
recognition and measurement of assets, 
liabilities and the associated performance of 
the Group or the Company when the relevant 
standards and interpretations come into effect.

77

FINANCIAL STATEMENTS0
2
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c
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1
3

d
e
d
n
e

r
a
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y

e
h
t

r
o
F

S
T
N
E
M
E
T
A
T
S
L
A
C
N
A
N
F

I

I

3) Segmental reporting
The following table provides disclosure of the Group’s revenue by geographical market based on 
location of the customer:

D
E
U
N
I
T
N
O
C

USA

Rest of world

2020
£000

10,695

2,134

12,829

2019
£000

10,679

2,354

13,033

Analysis of revenue by customer
During the year ending 31 December 2020, the Group had one customer who individually 
exceeded 10% of revenue. This customer generated 13% of revenue (2019: no customers).

Operating segments
The Group is organised into BioSurgery, Orthopaedics & Dental, GBM-V & Cardiac (recently 
merged due to size) divisions for internal management, reporting and decision making, based on 
the nature of the products of the Group’s businesses. Managers within these divisions report to 
the Chief Executive Officer. These are the reportable operating segments in accordance with IFRS 
8 “Operating Segments”. The Directors recognise that the operations of the Group are dynamic 
and therefore, this position will be monitored as the Group develops.

In accordance with IFRS 8, the Group has derived the information for its operating segments 
using the information used by the Chief Operating Decision Maker. The Group has identified 
the Chief Executive Officer as the Chief Operating Decision Maker as he is responsible for the 
allocation of resources to the operating segments and assessing their performance.

Central overheads, which primarily relate to operations of the Group function, are not allocated to 
the business unit.

E
H
T
O
T
S
E
T
O
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78

TISSUE REGENIX GROUP PLCANNUAL REPORT AND ACCOUNTS FOR THE YEAR ENDED 31 DECEMBER 2020 
 
  
 
 
 
 
 
 
 
3) Segmental reporting CONTINUED

BioSurgery

Orthopaedics 
& Dental

GBM-v & Cardiac

Central

Total

2020
£000

2019
£000

2020
£000

2019
£000

2020
£000

2019
£000

2020
£000

2019
£000

2020
£000

2019
£000

Revenue

3,308

4,233

7,446

6,724

2,075

2,076

Cost of sales

(1,849)

(2,535)

(3,848)

(3,076)

(1,236)

(1,403)

Gross Profit

1,459

1,698

3,598

3,648

839

673

–

–

–

–

–

–

12,829

13,033

(6,933)

(7,014)

5,896

6,019

(2,660)

(3,729)

(4,977)

(4,553)

(1,104)

(991)

(1,325)

(3,925)

(10,066)

(13,198)

–

–

1,523

–

–

–

–

(983)

(6,130)

(72)

(69)

(14)

–

–

–

(101)

–

–

–

–

–

–

1,523

(152)

(176)

(6,130)

(1,311)

–

–

–

(238)

(92)

(353)

(164)

–

40

–

–

–

(69)

855

–

–

–

–

–

Grant Income

325

–

490

(876)

(3,155)

(7,033)

618

(366)

(470)

(1,523)

(4,193)

(9,798)

(7,200)

–

–

(443)

–

–

–

–

(460)

(443)

(460)

Administrative
costs

Exceptional
costs:

Contingent
consideration

Impairment of
assets

Restructuring
costs

Litigation costs

Operating 
(loss)/profit

Finance 
(expense)

(Loss)/profit 
before
taxation

(876)

(3,155)

(7,476)

Taxation

(22)

159

426

618

283

(366)

(470)

(1,523)

(4,653)

(10,241)

(7,660)

129

80

–

32

533

554

(Loss)/profit for 
the year

(898)

(2,996)

(7,050)

901

(237)

(390)

(1,523)

(4,621)

(9,708)

(7,106)

Revenue from all operating segments derives from the sale of biologic medical devices. 
Administrative expenses are broken down as follows

BioSurgery

Orthopaedics 
& Dental

GBM-v & Cardiac

Central

Total

2020
£000

2019
£000

2020
£000

2019
£000

2020
£000

2019
£000

2020
£000

2019
£000

2020
£000

2019
£000

Staff costs

(2,106)

(2,862)

(2,607)

(2,931)

(423)

(483)

(527)

(889)

(5,663)

(7,165)

Sales and 
marketing 
costs

Research and 
development

Depreciation 
and 
amortisation

Establishment 
and 
administration 
costs

Administrative 
costs

(306)

(395)

(13)

(136)

–

(20)

(16)

(204)

(335)

(755)

(118)

(256)

(257)

(530)

(164)

(172)

(7)

(409)

(546)

(1,367)

–

(15)

(756)

(276)

(3)

(17)

(3)

(739)

(762)

(1,047)

(130)

(201)

(1,344)

(680)

(514)

(299)

(772)

(1,684)

(2,760)

(2,864)

(2,660)

(3,729)

(4,977)

(4,553)

(1,104)

(991)

(1,325)

(3,925)

(10,066)

(13,198)

79

FINANCIAL STATEMENTS0
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d
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S
T
N
E
M
E
T
A
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S
L
A
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N
A
N
F

I

I

D
E
U
N
I
T
N
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3) Segmental reporting CONTINUED
The balance sheet can be analysed segmentally as follows:

BioSurgery

Orthopaedics 
& Dental

GBM-v & Cardiac

Central

Total

2020
£000

2019
£000

2020
£000

2019
£000

2020
£000

2019
£000

2020
£000

2019
£000

2020
£000

2019
£000

Non-current 
assets

Intangible 
assets

Property, 
Plant & 
Equipment

Right of use 
asset

Total non-
current 
assets

Current 
assets

–

–

–

–

–

10,931

17,999

–

–

3,214

2,357

2,292

–

–

16,437 20,356

–

4

–

4

–

–

–

–

–

34

166

200

–

–

–

–

10,931

17,999

3,252

2,357

2,458

–

16,641 20,356

Inventory

1,308

345

5,530

3,661

150

122

84

57

7,072

4,185

Trade & other 
receivables

Cash & cash 
equivalents

Total current 
assets

Total assets

Liabilities

Trade & other 
payables

Borrowings

Lease liability

Total 
liabilities

Net assets/
(liabilities)

Capital 
expenditure

Additions to 
intangible 
assets

578

1,078

2,142

1,666

504

293

244

537

3,468

3,574

181

495

143

87

141

41

9,085

1,757

9,550

2,380

2,067

2,067

1,918

7,815

5,414

1,918 24,252 25,770

795

799

456

456

9,413

9,613

2,351

20,090

10,139

2,351

36,731 30,495

(287)

(586)

(2,007)

(2,163)

(174)

(154)

(539)

(882)

(3,007)

(3,785)

–

–

– (2,790)

(2,115)

– (2,367)

–

–

–

–

–

–

(160)

–

–

(2,790)

(2,115)

(2,527)

–

(287)

(586)

(7,164)

(4,278)

(174)

(154)

(699)

(882)

(8,324)

(5,900)

1,780 (1,332)

17,088 21,492

625

302

8,914

1,469

28,407 24,595

–

–

6

3,789

349

213

215

–

–

–

–

–

224

83

4,013

438

–

–

215

213

E
H
T
O
T
S
E
T
O
N

80

TISSUE REGENIX GROUP PLCANNUAL REPORT AND ACCOUNTS FOR THE YEAR ENDED 31 DECEMBER 2020 
 
  
 
 
 
 
 
 
 
4) Loss from operations

Loss from operations is stated after charging/(crediting):

Depreciation of plant and equipment (see note 10)

Amortisation of intangible asset (see note 12)

Rentals subject to “short lease” exemption

Expensed inventory

Staff costs (see note 5)

Foreign exchange losses/(gains)

Research and development (exclusive of research and 
development staff costs)

Sales and marketing costs (exclusive of sales and marketing staff 
costs and commissions)

Exceptional items:

Restructuring costs

Remeasurement of contingent consideration

Impairment of non-current assets

Litigation costs

Auditor remuneration:

– fees payable to Company’s Auditor for the audit of the parent 
Company and consolidated financial statements

– auditing the financial statements of subsidiaries pursuant to 
legislation

Other services:

– fees in relation to cyber attack

– fees in relation to corporation tax

Total auditor’s remuneration

Grant Income

USA

Rest of world

2020
£000

192

570

116

5,990

5,663

53

546

335

353

–

6,130

–

6,483

20

70

108

–

198

2020
£000

815

40

855

2019
£000

476

571

213

5,803

7,165

(1)

1,368

755

164

(1,523)

1,311

69

21

20

53

–

43

116

2019
£000

–

–

–

During the year the US subsidiaries of the Group were successful in their applications for two US 
Government PPP loans . The Loans have a two year term and carry a 1% annual interest rate deferred 
for 6 months, however, under the Loan agreement, the total amount of the Loan will not require 
repayment if the funds are used to support employee payroll, healthcare, utilities and rent payments 
within the US during the six months following inception. The Group believes they have met the above 

conditions and is presenting the loans in the Financial statements as grant income. 

The UK companies applied for and received £40k under the UK government furlough scheme in 2020.

Grant income is presented within Operating activities within the cashflow statement.

81

FINANCIAL STATEMENTS0
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2

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b
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c
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1
3

d
e
d
n
e

r
a
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y

e
h
t

r
o
F

S
T
N
E
M
E
T
A
T
S
L
A
C
N
A
N
F

I

I

D
E
U
N
I
T
N
O
C

5) Staff costs

The average monthly number of persons (including Directors) 
employed by the Group during the period was:

Directors

Laboratory and administration staff

The aggregate remuneration, including Directors, comprised:

Wages and salaries

Share based payments (see note 21)

Social security, pension & healthcare costs

2020
No.

5

73

78

2020
£000

4,717

(60)

1,006

5,663

2019
No.

7

92

99

2019
£000

6,178

(194)

1,181

7,165

Directors’ remuneration included above comprised:

Emoluments for qualifying services

711

734

Social security, pension and healthcare costs include pension contributions of £98k (2019: £71k).

Directors’ emoluments disclosed above include £490,000 paid to the highest paid Director 
(2019: £250,000). The share-based payments charge for Directors was nil (2019: £nil).

6) Finance income

Bank interest receivable

7) Finance charges

Imputed interest on deferred consideration

Interest on bank loans

Interest on lease liabilities

8) Taxation
Tax on loss on ordinary activities

Current tax:

UK R&D tax credit 

US corporation tax payable

Deferred tax:

Origination and reversal of temporary timing differences

Tax credit on loss on ordinary activities

2020
£000

2

2020
£000

–

(245)

(200)

(445)

2020
£000

(440)

–

(440)

(93)

(533)

2019
£000

17

2019
£000

(93)

(384)

-

(477)

2019
£000

(488)

29

(459)

(95)

(554)

E
H
T
O
T
S
E
T
O
N

82

TISSUE REGENIX GROUP PLCANNUAL REPORT AND ACCOUNTS FOR THE YEAR ENDED 31 DECEMBER 2020 
 
  
 
 
 
 
 
 
 
8) Taxation CONTINUED
Factors affecting the current tax charges
The tax assessed for the year varies from the main rate of corporation tax as explained below:

Loss on ordinary activities before tax

Tax at the standard rate of corporation tax 19% (2019: 19%)

Effects of:

Research and development tax credits received

Surrender of research and development relief for repayable tax 
credit including enhancement

Unutilised tax losses

Tax credit for the period

Unrecognised deferred tax

Tax losses

Losses available to carry forward against future trading profits

*Deferred tax asset – at 19% (2019: 17%)

2020
£000

(10,241)

(1,946)

(314)

432

1,295

(533)

2020
£000

51,104

9,710

2019
£000

(7,660)

(1,456)

(468)

305

1,064

(554)

2019
£000

43,533

7,404

* The Group has not recognised a deferred tax asset relating to these losses as their recoverability is uncertain.

The enacted UK corporation tax rate of 19% forms the basis for the UK element of the deferred tax 
calculation, following the UK budget in 2021 the chancellor announced an increase to the main 
rate of corporation tax in the UK to 25% from April 2023, if applied this would significantly increase 
the value of the unrecognised deferred tax asset.

9) Loss per share (basic and diluted)
Basic loss per share is calculated by dividing the loss attributable to equity holders of the parent by 
the weighted average number of ordinary shares in issue during the period excluding own shares 
held jointly by the Tissue Regenix Employee Share Trust and certain employees.

Diluted loss per share is calculated by adjusting the weighted average number of ordinary shares 
in issue during the year to assume conversion of all dilutive potential ordinary shares.

Total loss attributable to the equity holders of the parent

2020
£000

(9,709)

2019
£000

(6,973)

No.

No.

Weighted average number of ordinary shares in issue during the 
year

4,447,666,932

1,171,867,216

Loss per share

Basic and diluted loss for the year

(0.22)p

(0.60)p

As set out in note 21 the Company has options issued over 50,803,039 (2019: 19,553,729) ordinary 
shares and there are 16,112,800 (2019: 16,112,800) jointly owned shares which are potentially dilutive. 
There is, however, no dilutive effect of these issued options as there is a loss for each of the periods 
concerned.

83

FINANCIAL STATEMENTS0
2
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2

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b
m
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c
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1
3

d
e
d
n
e

r
a
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y

e
h
t

r
o
F

S
T
N
E
M
E
T
A
T
S
L
A
C
N
A
N
F

I

I

D
E
U
N
I
T
N
O
C

10) Property, plant and equipment

Building &
land
£000

Laboratory 
equipment
£000

Fixtures &
fittings
£000

Computer 
equipment
£000

2,001

(70)

–

–

1,931

(32)

1,059

2,958

78

(1)

45

–

–

122

(3)

48

167

2,791

1,809

1,923

1,726

(40)

318

–

2,004

(34)

84

2,054

1,189

(24)

248

–

123

1,536

(5)

124

1,655

399

468

537

680

(5)

92

–

767

(12)

–

755

427

(1)

124

–

179

729

–

8

737

18

38

253

Cost

At 31 December 2018

Exchange Adjustment

Additions

Disposals

At 31 December 2019

Exchange Adjustment

Additions

At 31 December 2020

Depreciation

At 31 December 2018

Exchange Adjustment

Charge for the period

Disposals

Impairment (note 12)

At 31 December 2019

Exchange Adjustment

Charge for the period

At 31 December 2020

Net book value

At 31 December 2020

At 31 December 2019

At 31 December 2018

11) Right of use assets 

Cost

At 31 December 2019

Additions

At 31 December 2020

Depreciation

At 31 December 2019

Exchange adjustment

Charge for the period

At 31 December 2020

Net Book Value

At 31 December 2020

At 31 December 2019

590

(10)

28

(2)

606

(3)

15

618

475

(5)

59

(2)

37

564

(2)

12

574

44

42

115

Land and 
Buildings
£000

–

2,518

2,518

–

6

(66)

60

2,458

–

Total
£000

4,997

(125)

438

(2)

5,308

(81)

1,158

6,385

2,169

(31)

476

(2)

339

2,951

(10)

192

3,133

3,252

2,357

2,828

Total
£000

–

2,518

2,518

–

6

(66)

60

2,458

–

E
H
T
O
T
S
E
T
O
N

84

TISSUE REGENIX GROUP PLCANNUAL REPORT AND ACCOUNTS FOR THE YEAR ENDED 31 DECEMBER 2020 
 
  
 
 
 
 
 
 
 
12) Intangible assets

t
n
e
m
p
o
e
v
e
D

l

s
t
s
o
c

0
0
0
£

l
l
i

w
d
o
o
G

0
0
0
£

r
e
m
o
t
s
u
C

i

s
p
h
s
n
o
i
t
a
e
r

l

s
k
r
a
m
e
d
a
r
T

0
0
0
£

s
s
e
c
o
r
P

h
c
e
T

0
0
0
£

s
t
n
e
m
e
e
r
g
a

r
e

i
l

p
p
u
S

0
0
0
£

0
0
0
£

l

a
t
o
T

0
0
0
£

Cost

At 31 December 2018

Additions*

Exchange adjustment

At 31 December 2019

Additions*

Exchange adjustment

759

213

–

972

215

–

15,333

2,364

–

(71)

15,262

–

(522)

–

(294)

2,070

–

(71)

At 31 December 2020

1,187

14,740

1,999

Amortisation

At 31 December 2018

Charge for the period

Exchange Adjustment

Impairment (see below)

At 31 December 2019

Charge for the period

Impairment (see below)

Exchange adjustment

–

–

–

972

972

–

–

–

–

–

–

–

–

–

6,130

–

At 31 December 2020

972

6,130

329

234

(15)

–

548

234

–

(33)

749

Net book value

At 31 December 2020

At 31 December 2019

At 31 December 2018

215

–

759

8,610

15,262

15,333

1,250

1,522

2,035

*Additions in both years arose from internal development.

630

–

(78)

552

–

(19)

533

176

125

(8)

–

293

125

–

(17)

401

132

259

454

1,182

–

(147)

1,035

–

(35)

1,000

165

117

(9)

–

273

117

–

(15)

375

625

762

1,017

473

20,741

–

(59)

414

–

(14)

400

133

94

(7)

–

220

94

–

(13)

301

99

194

340

213

(649)

20,305

215

(661)

19,859

803

570

(39)

972

2,306

570

6,130

(78)

8,928

10,931

17,999

19,938

Goodwill, customer relationships, trademarks, process technology and supplier agreement all 
relate entirely to the acquisition of CellRight Technologies LLC in 2017 and is subject to annual 
impairment testing as described below. The remaining amortisation periods for intangible assets 
which all arose on the acquisition of CellRight Technologies LLC are: Customer relationships:  
6.8 years, Trade marks: 1.8 years, Process Tech: 6.8 years, Supplier agreements: 1.8 years.

Impairment of non-current assets

Annual impairment test on CellRight Technologies LLC (“CellRight”)

The Group tests the CellRight cash generating unit (CGU) on an annual basis, or more frequently 
where impairment indicators exist, by comparing the carrying value of the CGU with its value 
in use. Value in use is estimated based on future cash flow discounted to present value using a 
pre-tax discount rate of 14.6% (2019: 13.5%) that reflects current market assessments of the time 
value of money. An impairment charge arises where the carrying value exceeds the value in use. 
The CellRight CGU is part of the Orthopaedics and Dental segment disclosed in note 3 and is the 
group’s human tissue production and sales business in San Antonio, Texas.

The inputs into cash flow forecasts are based on the most recent budgets/forecasts approved 
and reviewed by the Directors for the following year, and extended forward for the next four years 
based on expected growth within that CGU over that period. At the end of year five, a terminal 
value is calculated using a long-term growth assumption of 2% (2019: 2%). Due to the uncertainty 
created by the Covid-19 pandemic the Directors have taken a cautious approach to the forecasts 
used in the calculation of value in use and in particular the assumption disclosed below in respect 
of future revenue growth.

85

FINANCIAL STATEMENTS 
 
0
2
0
2

r
e
b
m
e
c
e
D

1
3

d
e
d
n
e

r
a
e
y

e
h
t

r
o
F

S
T
N
E
M
E
T
A
T
S
L
A
C
N
A
N
F

I

I

D
E
U
N
I
T
N
O
C

12) Intangible assets CONTINUED
The key inputs to the cash flow forecasts are:

 ▶ revenues (based on estimates of revenue growth with both new and existing customers based 

on an understanding of the needs of those customers and having regard to independent 
market assessments of market growth);

 ▶ gross margin and overheads (based on existing gross margins and adapted for appropriate 

increases base on the anticipated growth of the business);

 ▶ future anticipated capital expenditure (adjusted based on expected future growth); and

 ▶ movements in working capital.

The key assumption within the cash flow forecasts relates to sales growth which is inherently 
difficult to forecast in light of the pandemic. Across the five-year forecast period the compound 
annual growth rate (CAGR) is 18% which is significantly lower than the CAGR used in the prior year 
of 26% reflecting the uncertainty present in the group’s markets at 31 December 2020. 

The impairment test prepared by the Directors indicates a recoverable amount based on value 
in use of £22,412,000 compared to a CGU carrying amount of £28,542,000. The Directors have 
therefore recorded an impairment charge of £6,130,000 in these financial statements which has 
been allocated in full against the goodwill that arose on the original acquisition of CellRight. The 
Directors attribute the reason for this impairment to be the uncertainty created by the Covid-19 
pandemic.

13) Inventory

Raw materials and consumables

Work in progress

Finished goods including goods for resale

Total

Inventory is presented net of a provision of £271k (2019: £nil).

14) Trade and other receivables

Trade debtors

Other receivables

Prepayments and accrued income

2020
£000

1,991

3,522

1,559

7,072

2020
£000

1,785

95

763

2,643

2019
£000

1,199

2,271

715

4,185

2019
£000

1,719

341

479

2,539

The Directors consider that the carrying amounts of trade and other receivables approximate to 
their fair values.

Trade receivables

Less: Allowance for expected credit losses

2020
£000

1,817

(32)

1,785

2019
£000

1,813

(94)

1,719

E
H
T
O
T
S
E
T
O
N

86

TISSUE REGENIX GROUP PLCANNUAL REPORT AND ACCOUNTS FOR THE YEAR ENDED 31 DECEMBER 2020 
 
  
 
 
 
 
 
 
 
14) Trade and other receivables CONTINUED
Allowance for expected credit losses
The ageing of the receivables and allowance for expected credit losses provided for above are as 
follows:

not overdue

0 to 3 months overdue

3 to 4 months overdue

4 to 5 months overdue

over 5 months overdue

Expected 
credit loss
rate

0%

0%

25%

50%

100%

Carrying 
amount
2020
£000

Allowance 
for expected 
credit losses
2020
£000

975

820

14

20

(12)

1,817

–

–

10

13

9

32

Carrying 
amount 
2019
£000

1,565

131

30

1

86

1,813

Allowance 
for expected 
credit losses
2019
£000

–

–

8

–

86

94

The average Credit terms with customers is 40 days (2019: 40 days). Trade receivables are analysed 
by the currencies of settlement below:

US Dollars

Euros

Sterling

Trade debtors

2020
£000

1,564

211

10

1,785

Movements in the impairment allowance for trade receivables are as follows:

Opening provision for impairment of trade receivables

Increase during the year

Receivables written off during the year as uncollectable

Unused amounts reversed

At 31 December 2020

2020
£000

94

27

–

(89)

32

2019
£000

1,601

118

–

1,719

2019
£000

245

135

–

(474)

94

87

FINANCIAL STATEMENTS0
2
0
2

r
e
b
m
e
c
e
D

1
3

d
e
d
n
e

r
a
e
y

e
h
t

r
o
F

S
T
N
E
M
E
T
A
T
S
L
A
C
N
A
N
F

I

I

D
E
U
N
I
T
N
O
C

15) Risk management of financial assets and liabilities
The Group’s activities expose it to a variety of financial risks: Market risks, specifically interest rate 
risk, credit risk, liquidity risk, capital risk and foreign currency exchange rates. The management 
of these risks is vested in the Board of Directors. The policies for managing each of these risks are 
summarised below:

Management of market risk

Interest rate risk

The risk in the potential movement in interest received on cash surpluses held is limited due to 
little movement on deposit interest rates. Interest on the debt is at a fixed rate above LIBOR. 

Accordingly, no sensitivity analysis has been presented as this is immaterial.

Management of credit risk
The Group is exposed to credit risk from its operating activities; it principally arises from short 
term bank deposits and trade debtors. The Group seeks to minimise this risk by only depositing 
funds with banks with a high credit rating.

The maximum exposure to credit risk on the Group’s financial assets is represented by their 
carrying amounts as outlined in the categorisation of financial instruments table below.

Trade debtor credit risk is mitigated by carrying out a credit review on all customers and setting a 
credit allowance that reflects the risk (see note 14).

The Group had cash and cash equivalents at each reporting date as set out below.

Cash and cash equivalents

AA-

A+

A

A-

BBB+

2020
£000

317

515

8,498

79

141

2019
£000

–

1,000

1,380

-

-

9,550

2,380

The above has been split by the Fitch rating system and gives an analysis of the credit rating of the 
financial institutions where cash balances are held.

Management of liquidity risk

The Group seeks to manage liquidity risk to ensure that sufficient liquidity is available to meet 
foreseeable needs and to invest cash assets safely and profitably.

With the exception of borrowings detailed in note 17 and leases in note 19, all of the Group’s 
financial liabilities mature within less than six months (2019: all within six months). At 31 December 
2020 the Group was in compliance with all terms relating to the MidCap facilities and undrawn 
committed facilities of £702k were available to draw down. The maturity of borrowings was as 
follows:

Less than 6 months

6 months to 1 year

1 year to 2 years

2 years to 5 years

2020
£000

–

–

–

2,790

2,790

2019
£000

–

171

342

1,773

2,286

E
H
T
O
T
S
E
T
O
N

88

TISSUE REGENIX GROUP PLCANNUAL REPORT AND ACCOUNTS FOR THE YEAR ENDED 31 DECEMBER 2020 
 
  
 
 
 
 
 
 
 
15) Risk management of financial assets and liabilities CONTINUED
Capital risk management
The Group manages its capital to ensure that the Group will be able to continue as a going 
concern while maximising the return to stakeholders. The Group’s overall strategy is to minimise 
costs and liquidity risk.

The capital structure of the Group consists of equity attributable to the owners of the Group, 
comprising issued capital, reserves and retained earnings as disclosed in note 20 and in the 
Statement of Changes in Equity.

Foreign currency risk management
The Group’s exposure to currency exchange rates arises principally from assets and liabilities 
which are denominated and settled in local currency. While the combination of assets and 
liabilities provides an element of natural hedging, there is an element of residual risk that can 
impact the performance of the results of the Group over the course of each financial reporting 
period. Foreign currency transactions are principally denominated in Dollars and Euros, and the 
associated foreign currency denominated financial assets and liabilities are set out below:

Financial assets

Financial liabilities

Short-term exposure

2020
$000

1,564

(7,052)

(5,488)

2019
$000

1,601

(4,118)

(2,517)

2020
€000

195

(148)

47

2019
€000

121

(67)

54

The Group has exposure to the movements in the exchange rates in the Dollar and Euro at 
31 December 2020. An analysis of the effect of a reasonably possible movement in exchange rates 
shows that a movement of 10% in the exchange rate could result in net foreign currency gains of 
£745k (2019: £311k) against the Dollar and gain £5k (2019: £5k) against the Euro.

Categorisation of financial instrument

Financial assets/(liabilities)

At 31 December 2020

Trade and other receivables

Cash and cash equivalents

Borrowings

Lease liabilities

Trade and other payables

Financial assets/(liabilities)

At 31 December 2019

Trade and other receivables

Cash and cash equivalents

Borrowings

Lease liabilities

Trade and other payables

Financial 
assets at 
amortised
cost
£000

Financial 
liabilities at 
amortised
cost
£000

Financial 
liabilities 
held at fair
value
£000

1,880

9,550

–

–

–

11,430

–

–

(2,790)

(2,527)

(2,897)

(8,214)

–

–

–

–

–

–

Financial 
assets at 
amortised
cost
£000

Financial 
liabilities at 
amortised
cost
£000

Financial 
liabilities 
held at fair
value
£000

2,060

2,380

–

–

–

4,440

–

–

(2,286)

–

(2,868)

(5,154)

–

–

–

–

–

–

Total
£000

1,880

9,550

(2,790)

(2,527)

(2,897)

3,216

Total
£000

2,060

2,380

(2,286)

–

(2,868)

(714)

89

FINANCIAL STATEMENTS0
2
0
2

r
e
b
m
e
c
e
D

1
3

d
e
d
n
e

r
a
e
y

e
h
t

r
o
F

S
T
N
E
M
E
T
A
T
S
L
A
C
N
A
N
F

I

I

16) Trade and other payables

D
E
U
N
I
T
N
O
C

Current:

Trade payables

Taxes and social security

Accruals

2020
£000

975

110

1,922

3,007

2019
£000

1,650

76

1,218

2,944

The Directors consider that the carrying amount of trade and other payables and accruals 
approximates to their fair value. Trade payables are analysed by the currencies of settlement below:

Sterling

US Dollars

Euros

Trade payables

 17) Borrowings

At 31 December 2020

Term Loan

Revolving Credit

Gross borrowings

Less capitalised debt issue costs

Borrowings

At 31 December 2019

Term Loan

Revolving Credit

Gross borrowings

Less capitalised debt issue costs

Borrowings

2020
£000

129

735

111

975

2019
£000

310

1,273

67

1,650

Interest rate

% Maturity

Current
£000

Non-current
£000

 LIBOR RATE +6.75% Jun 2024

LIBOR RATE +4.5% Jun 2024

–

–

–

–

–

1,473

1,507

2,980

(190)

2,790

Interest rate

% Maturity

Current
£’000

Non-current
£’000

LIBOR RATE +6.75% Jun 2024

LIBOR RATE +4.5% Jun 2024

171

–

171

–

171

1,627

761

2,388

(273)

2,115

E
H
T
O
T
S
E
T
O
N

90

TISSUE REGENIX GROUP PLCANNUAL REPORT AND ACCOUNTS FOR THE YEAR ENDED 31 DECEMBER 2020 
 
  
 
 
 
 
 
 
 
17) Borrowings CONTINUED
A US dollar denominated revised bank facility was signed by the Group in June 2019 with MidCap 
Financial Trust (“MidCap”). The bank loans outstanding at 31 December 2020 are represented by 
the following:

Term Loan: 5 years to June 2024. $2m current facility. Interest maximum 6.75% above LIBOR RATE. 
Repayments of $167,000 per month from July 2023. Maturity analysis as detailed in note 15.

Revolving Credit: Repayable in full on June 2024 at the latest. $3m maximum drawing. Interest 
maximum 4.5% above LIBOR RATE.

As part of these facilities, MidCap hold security over the Group’s freehold property in San Antonio 
and IP in respect of the Term Loan. The carrying amount of these assets pledged as security was 
£2.8m and £nil at 31 December 2020 (2019: £1.8m and £nil). The MidCap debt facility is subject to 
revenue covenants.

Also as part of these facilities, a warrant equating to 3% of the value of term loan was granted to 
MidCap in 2019 equating to an option over 3,096,798 at an exercise prices of £0.0574. The warrant 
gave rise to a share based payment charge in 2019 as detailed in note 21.

Debt issue costs of £303k were capitalised against the loan and will be amortised to the income 
statement over the life of the term loan.

The movement in total borrowings during the year was as follows:

Borrowings

Lease liabilities

Total Liabilities from 
financing activities 

2019
£000

2,115

–

2,115

Cashflows
£000

528

–

528

Non-cash 
changes 
Foreign 
exchange 
movement
£000

Non-cash 
changes 
Additions
£000

Non-cash 
changes 
Other
£000

–

2,527

2,527

93

–

93

54

–

54

Non-cash 
changes 
Foreign 
exchange 
movement
£000

Non-cash 
changes 
Additions
£000

2018
£000

Cashflows
£000

Borrowings

Total Liabilities from 
financing activities 

–

–

(4,193)

6,479

(4,193)

6,479

102

102

18) Deferred tax liabilities

As at December 2019

Release to the income statement

Exchange adjustment

As at December 2020

Non-cash 
changes 
Other
£000

(273)

(273)

2,155

Total
£’000

670

(93)

(17)

560

2020
£000

2,790

2,527

5,317

2019
£000

2,155

The deferred tax liability relates wholly to non-current assets recognised on acquisition of 
CellRight Technologies LLC.

91

FINANCIAL STATEMENTS0
2
0
2

r
e
b
m
e
c
e
D

1
3

d
e
d
n
e

r
a
e
y

e
h
t

r
o
F

S
T
N
E
M
E
T
A
T
S
L
A
C
N
A
N
F

I

I

19) Lease liabilities
Lease liabilities, excluding short-term and low value leases, included in the Statement of Financial 
Position were as follows:

D
E
U
N
I
T
N
O
C

Current Lease liabilities

Non–current liabilities

2020
£000

(256)

(2,271)

(2,527)

2019
£000

–

–

–

Maturity analysis of lease liabilities
The maturity of the gross contractual undiscounted cashflows due on the Group’s lease liabilities 
(excluding short-term and low value leases) is set out below based on the period between 
31 December 2020 and the contractual maturity date.

Land and buildings

Less than 6 months

6 months to 1 year

1 year to 2 years

2 years to 5 years

5 or more years

2020
£000

133

133

287

2,948

–

3,501

2019
£000

–

–

–

–

–

–

Disclosure of the carrying amounts of right of use assets by class and additions to right of use 
assets has been provided in note 11.

Effect of leases on financial performance

Depreciation charge for the year:

Administrative expenses

Interest expenses for the year on lease liabilities recognised in 
‘finance costs’

Total effect of leases on financial performance

2020
£000

477

200

677

2019
£000

–

–

–

Lease terms
The Group leases properties used for its operations in the UK and US. Lease terms are 5 years. 

Terms on specific property leases also include:

UK Property: 5 year fixed lease and includes a break clause in 2023

US property: 5 year fixed and includes the option to purchase up to 2025

The Group average effective borrowing rate for leases at 31 December 2020 was 9%.

E
H
T
O
T
S
E
T
O
N

92

TISSUE REGENIX GROUP PLCANNUAL REPORT AND ACCOUNTS FOR THE YEAR ENDED 31 DECEMBER 2020 
 
  
 
 
 
 
 
 
 
20) Share capital

Ordinary shares of 0.1 pence

Deferred shares of 0.4 pence

Ordinary shares of 0.5 pence

Movements on share capital during the period were as follows:

At 31 December 2018

Ordinary shares
Number

1,171,730,823

Issued on exercise of share options

240,499

At 31 December 2019

  Sub-division of shares

1,171,971,322

Issued on exercise of share options

1,479,965

Issue of shares

5,859,626,212

2020
£000

7,033

4,687

–

11,720

Deferred 
shares
Number

–

–

–

£000

5,859

–

5,859

2019
£000

–

–

5,859

5,859

£000

–

–

–

(4,687)

1,171,971,322

4,687

1

5,860

–

–

–

–

At 31 December 2020

7,033,077,499

7,033

1,171,971,322

4,687

All shares are ordinary shares which are fully paid and entitle the holder to full voting rights, The 
shares may be considered by the Directors when considering dividends from time to time. On 9 
June 2020, a special resolution was passed at the general meeting for the 1,171,971,322 Ordinary 
Shares of 0.5 pence each in the issued share capital of the Company to be sub-divided into 
1,171,971,322 Ordinary Shares of 0.1 pence each in the capital of the Company and 1,171,971,322 
Deferred Shares of 0.4 pence each in the capital of the Company. The sub-division of shares was 
undertaken in order to facilitate the fundraise described below. The Deferred shares have no rights 
other than to a return of capital in the event of a winding up (and only after the holders of the 
Ordinary Shares have received the sum of £1m per share).

On 9 June 2020, the Company also completed a successful fundraise of £14.6m gross (£13.8m net).

Reserves of the Group represent the following:

Share Premium

Consideration received for shares issued above their nominal value net of transaction costs.

Merger Reserve

Consideration and nominal value of the shares issued during a merger and the fair value of the 
assets transferred differ.

Reverse Acquisition

Retained earnings of a reverse acquisition.

Own shares held

The Company’s authority to purchase its own shares is set out in its Articles of Association and 
approved by the shareholders at the Annual General Meeting.

Share-based Payment Reserve (note 21)

The cumulative share-based payment expense.

Retained Earnings

Cumulative profit and loss net of distributions to owners. 

As permitted by the provisions of the Companies Act 2006, the Company does not have an upper 
limit to its authorised share capital. All shares are ordinary shares which are fully paid and entitle 
the holder to full voting rights, to full participation or distribution of dividends.

As described in note 21, there were employee related share options outstanding at 31 December 
2020 of 66,915,839 over shares (2019: 32,569,731 shares) and options issued to providers of 
borrowings over 3,096,798 shares (2019: 3,096,798).

93

FINANCIAL STATEMENTS 
 
 
0
2
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2

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c
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1
3

d
e
d
n
e

r
a
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y

e
h
t

r
o
F

S
T
N
E
M
E
T
A
T
S
L
A
C
N
A
N
F

I

I

D
E
U
N
I
T
N
O
C

21) Share based payments
Share options and shares held in employee benefit trust (“EBT”)

The Company operates a share option plan, under which certain employees have been granted 
options to subscribe for ordinary shares. All options are equity settled. The options have an exercise 
price of between 0.3p to 22.5p and a vesting period between one and three years. If the options 
remain unexercised after a period of 10 years from the date of grant, the options expire. The Group 
has no legal or constructive obligation to repurchase or settle the options in cash.

The Group also operates a jointly-owned EBT share scheme for senior management under which 
the trustee of the Group sponsored EBT has acquired shares in the Group jointly with a number 
of employees. The shares were acquired pursuant to certain conditions, set out in Jointly Owned 
Equity agreements (“JOEs”). Subject to meeting the performance criteria conditions set out in 
the JOEs, the employees are able to benefit from most of any future increase in the value of the 
jointly owned EBT shares. The fair value benefit is measured using the Binomial model, taking into 
account the terms and conditions upon which the jointly owned shares were purchased.

The number and weighted average exercise prices of share options and EBT shares are as follows:

Number of share interests

EMI 
options

Unapproved
options

EBT 
shares

SAYE
options

Total

Weighted 
average 
exercise 
price per 
share (£)

At 31 December 2018

5,267,716

46,842,030 16,112,800

1,477,869

69,700,415

0.0882

Exercised in the 
period

Lapsed during year

Issued in the year

–

–

–

(240,499)

(41,842,799)

–

–

–

–

–

(240,499)

0.0050

(1,749,766)

(43,592,565)

6,702,380

6,702,380

0.1010

0.0281

At 31 December 2019

5,267,716

4,758,732 16,112,800

6,430,483

32,569,731

0.0596

Exercised in the 
period

–

(1,479,965)

–

–

(1,479,965)

0.0008

Lapsed during year

(4,047,279)

(1,435,293)

– (6,430,483)

(11,913,055)

Issued in the year

–

–

–

47,739,128

47,739,128

At 31 December 2020 1,220,437

1,843,474 16,112,800 47,739,128

66,915,839

0.0615

0.0028

0.0180

Excluding the EBT shares, there were 573,381 share options outstanding at 31 December 2020 
(2019: 4,361,603) eligible to be exercised. The remaining options were not eligible to be exercised 
as these are subject to employment period and market based vesting conditions, some of which 
had not been met at 31 December 2020. The range of exercise prices applicable to share options is 
between 0.3p and 22.5p and the remaining options eligible to be exercised for 12p.

There were 16,112,800 of the jointly held EBT shares which were eligible to vest as at 31 December 
2020.

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94

TISSUE REGENIX GROUP PLCANNUAL REPORT AND ACCOUNTS FOR THE YEAR ENDED 31 DECEMBER 2020 
 
  
 
 
 
 
 
 
 
21) Share based payments CONTINUED
The fair value benefit received on share options granted is measured using the Binomial model 
taking in to account the effects of the vesting and performance conditions, expected exercise 
price and the payment of the dividends by the Company. The following table lists the inputs to the 
models used:

Dividend yield

Expected volatility (%)

Risk free interest rate (%)

Expected vesting life of EBT shares and options (years)

Options 
Granted 
year to
31 December
2020

Options 
Granted year 
to
31 December
2019

–

63

0.9

3

–

47

1.0

3

Weighted average fair value (£)

0.0180

0.0596

Share options issued under the Deferred Annual Bonus scheme (which is within the unapproved 
options) which are not exercised within four years from the date of grant will expire. Any other 
share options and employee interests in jointly owned EBT shares which are not exercised within 
10 years from the date of grant will expire. The weighted average remaining contractual life of 
options outstanding at the end of the financial year was 5.2 years (2019: 5.8 years). Expected 
volatility is based on historic share prices as published on LSE website.

Other Share Options
Warrants were issued in 2019 to MidCap as part of the Group’s new borrowing facilities. Options 
over 3,096,798 shares were granted at an exercise price of 5.74p . The binomial model was used 
to value the share based payment charge and that the assumptions adopted are consistent with 
those used in the calculation of 2019 employee share based payments above except the vesting 
period of nil. The warrants were measured using an option pricing model as the Directors have 
concluded that there is no other reliable way of measuring the service received.

A credit has been recognised in the statement of comprehensive income for the year as follows:

At 31 December 2018
Credit in respect of employment related share options
Charge for warrants issued to MidCap
At 31 December 2019
Credit in respect of employment related share options

At 31 December 2020

Share based payment reserves
£000

1,129
(242)
96
983
(28)

955

95

FINANCIAL STATEMENTS0
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22) Non-controlling interest

As at 31 December 2019

Attributable loss for the period

As at 31 December 2020

2020
£000

(615)

1

(614)

2019
£000

(482)

(133)

(615)

The non-controlling interest has 50% (2019: 50%) equity holding. GBM-V GmbH contributed revenue 
of £2,075k (2019: £2,076k) and a profit before tax of £2k (2019: loss £142k) for the year. Further 
financial information relating to GBM-V GmbH can be found in the segmental analysis in note 3.

23) Related party transactions 
Transactions with key management personnel
During the year the Group entered into the following transactions in which the Directors and 
senior management also had an interest: 

Remuneration received by the key management personnel (including Employers NI) from the 
Group is set out below:

Short-term employment benefits

24) Ultimate controlling party
The Directors believe that there is no ultimate controlling party.

2020
£000

971

2019
£000

836

25) Post balance sheet events
The Group carried out in January 2021 restructuring of the US Operations, this is estimated to save 
approximately $700k on an annualised basis.

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TISSUE REGENIX GROUP PLCANNUAL REPORT AND ACCOUNTS FOR THE YEAR ENDED 31 DECEMBER 2020 
 
  
 
 
 
 
 
 
 
T
N
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T
A
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S
Y
N
A
P
M
O
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0
2
0
2

I

Y
T
U
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N

I

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b
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c
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1
3

d
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d
n
e

r
a
e
y

e
h
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o
F

S
E
G
N
A
H
C
F
O

Share 
capital
£000

Share 
premium
£000

Merger 
reserve
£000

Share 
based
payment 
reserve
£000

Retained 
earnings 
reserve
£000

Total
£000

At 31 December 2018

5,859

86,398

10,884

1,056

(13,465)

90,732

Total expense and other 
comprehensive loss for the 
period

Contributions by and 
distributions to owners

Share options exercised

Share based payment credit

–

–

–

–

1

–

–

–

–

–

–

(146)

(50,001)

(50,001)

–

–

1

(146)

At 31 December 2019

5,859

86,399

10,884

910

(63,466)

40,586

Total expense and other 
comprehensive loss for the 
period

Contributions by and 
distributions to owners

–

–

Issue of shares

5,860

Costs of issue of new equity

Share options exercised

Share based payment credit

1

–

8,790

(899)

–

–

–

–

–

–

(15,048)

(15,048)

–

–

–

–

14,650

(899)

1

(3)

–

(3)

At 31 December 2020

11,720

94,290

10,884

907

(78,514)

39,287

97

FINANCIAL STATEMENTS 
  
 
 
 
 
 
 
 
 
 
Assets

Non-current assets

Investments

Intercompany loan receivables

Total non-current assets

Current assets

Trade and other receivables

Intercompany loan receivables

Cash and cash equivalents

Total current assets

Total assets

Liabilities

Current liabilities

Trade and other payables

Total liabilities

Net assets

Equity and reserves

Share capital

Share premium

Merger reserve

Share based payment reserve

Retained earnings deficit

Total equity

  Notes

2020
£000

2019
£000

C4

C6

C5

C6

C8

C7

20

C9

18,813

11,754

30,567

35

–

9,039

9,074

39,641

18,594

3,860

22,454

218

16,757

1,669

18,644

41,098

(354)

(354)

(512)

(512)

39,287

40,586

11,720

94,290

10,884

907

(78,514)

39,287

5,859

86,399

10,884

910

(63,466)

40,586

The Company has elected to take the exemption under section 408 of the Companies Act 2006 
not to present the parent Company’s statement of comprehensive income. The parent Company’s 
result for the period ended 31 December 2020 was a loss of £15,048k (2019: £50,001k).

The Company financial statements were approved by the Board of Directors and authorised for 
issue on 27 April 2021 and were signed on its behalf by

Daniel Lee
Chief Executive Officer 

Company number: 05969271

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3

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98

TISSUE REGENIX GROUP PLCANNUAL REPORT AND ACCOUNTS FOR THE YEAR ENDED 31 DECEMBER 2020 
  
 
 
 
 
 
0
2
0
2

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1
3

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Y
N
A
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Operating activities

Loss before interest and tax

Adjustment for non-cash items:

Share based payments

Impairment of intercompany loan receivables

Operating cash outflow

Decrease in trade and other receivables

(Decrease)/increase in trade and other payables

Net cash absorbed by operations

Investing activities

Loan to subsidiary undertaking

Interest received

Net cash used in investing activities

Financing activities

Gross proceeds from equity raise

Cost of issue of new equity

Proceeds from exercise of share options

Net cash generated from financing activities

Increase/(decrease) in cash and cash equivalents

Cash and cash equivalents at start of period

Cash and cash equivalents at end of period

Notes

2020
£000

2019
£000

C10

(15,594)

(50,646)

(222)

14,222

(1,594)

183

(159)

(146)

48,600

(2,192)

35

39

(1,570)

(2,118)

(5,359)

546

(4,813)

14,650

(899)

2

13,753

7,370

1,669

9,039

(4,021)

645

(4,021)

–

–

1

646

(5,493)

7,162

1,669

99

FINANCIAL STATEMENTS 
  
 
 
 
 
 
 
 
 
C1. Principal accounting policies
The separate financial statements of the Company are presented as required by the Companies 
Act 2006 and in accordance with international accounting standards in conformity with the 
Companies Act 2006 (‘IFRS’). The principal accounting policies adopted are the same as for those 
set out in the Group’s financial statements.

Adoption of new and revised standards
During the year, the Company has not adopted any new or amended standards early.

Investments
Fixed asset investments, including investments in subsidiaries, are stated at cost and reviewed for 
impairment if there are any indications that the carrying value may not be recoverable.

C2. Critical accounting estimates and judgements
Estimates and judgements are continually evaluated on historical experience and other factors, 
including expectations of future events that we believe to be reasonable under the circumstances. 
Actual results may differ from these estimates. The estimates that have the most significant 
effects on the carrying amounts of the assets and liabilities in the parent Company financial 
statements are described below:

Estimates:

Recoverability of receivables from subsidiaries and impairment of financial assets
The gross loan advanced by the Company to its subsidiary undertakings is £75,866,000 (2019: 
£70,699,000). In accordance with IFRS 9 Financial Instruments, as the subsidiary undertakings 
cannot repay the loans at the reporting date, the Company has made an assessment of expected 
credit losses. Having considered multiple scenarios on the manner, timing, quantum and 
probability of recovery on the receivables, a cumulative lifetime expected credit loss (ECL) of 
£64,132,000 has been recognised at 31 December 2020 (2019: £49,910,000).

The calculation of the allowance for lifetime expected credit losses requires a significant degree of 
estimation and judgement, in particular in determining the probability weighted likely outcome 
for each scenario considered. The Directors’ assessment of ECL included repayment through 
future cash flows over time (which are inherently difficult to forecast for the Company at its 
current stage of development) and also the amount that could be realised through an immediate 
sale of the subsidiary undertakings. The Directors’ assessment of repayment through future 
cash flows included scenarios where the loan was not recovered in full. The Directors allocated a 
probability weighting of 90% to scenarios where recovery would be repayment over time, and 10% 
to the scenario where immediate sale of the subsidiary undertaking was contemplated.

Given the quantum of the provision recorded at 31 December 2020, the outcome is materially 
sensitive to the key assumptions inherent in the calculation. The carrying value of amounts 
owned by subsidiary undertakings at 31 December 2020 is disclosed in note C10 to the financial 
statements.

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100

TISSUE REGENIX GROUP PLCANNUAL REPORT AND ACCOUNTS FOR THE YEAR ENDED 31 DECEMBER 2020 
 
  
 
 
 
 
 
 
 
C3. Staff costs

The average monthly number of persons (including Directors) 
employed by the Company during the period was:

Directors

Administration staff

The aggregate remuneration, including Directors, comprised:

Wages and salaries

Social security, pension & healthcare costs

2020
no.

2019
no.

5

2

7

7

1

8

£000

£000

631

141

772

941

144

1,085

Social security, pension and healthcare costs include pension contributions £33k (2019: £20k).

C4. Investment in subsidiary companies

Cost at 1 January

Push down of share based payment charges

Carrying value at 31 December 2020

£000

18,594

219

18,813

£000

18,594

–

18,594

At 31 December 2020, the Company held the following investments in subsidiaries:

Undertaking

Sector

Tissue Regenix Limited

Regenerative medicine

TRX Wound Care Limited

Regenerative medicine

TRX Orthopaedics Limited

Regenerative medicine

TRX Cardiac Limited

Regenerative medicine

TRX Vascular Limited

Dormant

Tissue Regenix Wound Care Inc*

Regenerative medicine

TRX Orthopedics Inc^

Regenerative medicine

Tissue Regenix Holdings Limited Holding company

Tissue Regenix Holdings Inc**

Holding company

CellRight Technologies LLC†

Regenerative medicine

GBM-V GmbH

Regenerative medicine

*  Held through TRX Wound Care Limited 

^  Held through TRX Orthopaedics Limited 

**  Held through Tissue Regenix Holdings Limited

Share of issued capital and 
voting rights

2020

100%

100%

100%

100%

100%

100%

100%

100%

100%

100%

50%

2019

100%

100%

100%

100%

100%

100%

100%

100%

100%

100%

50%

†  Held through Tissue Regenix Holdings Inc. All others are held through Tissue Regenix Limited.

Registered Addresses:
Tissue Regenix Limited, TRX Wound Care Limited, TRX Orthopaedics Limited, TRX Cardiac Limited, 
TRX Vascular Limited, Tissue Regenix Holdings Limited: Unit 3, Phoenix Court, Lotherton Way, 
Garforth, Leeds LS25 2GY.

Tissue Regenix Wound Care Inc, TRX Orthopedics Inc, CellRight Technologies LLC, Tissue Regenix 
Holding Inc: 1808 Universal City Boulevard, Universal City Texas, 78148.

GBM-V Gmbh: Schillingallee 68, 18057, Rostock, Germany.

101

FINANCIAL STATEMENTS0
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C5. Trade and other receivables

Prepayments & accrued income

Other debtors

C6. Intercompany loan receivables

Gross intercompany loan receivables

Less: Expected credit losses

Comprising:

Non-current assets

Current assets

2020
£000

31

4

35

2020
£000

75,886

(64,132)

11,754

11,754

–

11,754

2019
£000

22

196

218

2019
£000

70,527

(49,910)

20,617

3,860

16,757

20,617

Intercompany loans includes £828,000 gross (2019: 828,000) before provision of £740,889 due from 
the Group’s EBT (2019: £642,889) (see note C10). No interest was receivable on loans to subsidiary 
undertakings and the loans are repayable on demand except for £13,217,878 unsecured loan to 
Tissue Regenix Limited that is charged at 4% above the Bank of England base rate and repayable 
in 2024. Intercompany loans are classified as non-current on the basis that they are not expected 
to be repaid within 12 months.

C7. Trade and other payables

Trade creditors

Taxes & social security

Accruals

2020
£000

–

110

244

354

2019
£000

124

30

358

512

C8. Risk management of financial assets and liabilities
The Company’s activities expose it to a variety of financial risks: market risk, interest rate risk, 
credit risk and liquidity risk. The Company overall risk management programme focuses on the 
unpredictability of financial markets and seeks to minimise potential adverse effects on the 
Company financial performance.

The management of these risks is vested in the Board of Directors. The policies for managing each 
of these risks are summarised below:

Management of market risk

Interest rate risk

As the Company has no significant borrowings the risk is limited to the potential reduction in 
interest received on cash surpluses held. Interest rate risk is managed in accordance with the 
liquidity requirement of the Company.

Management of credit risk
The Company is exposed to credit risk from its operating activities; it principally arises from 
short term bank deposits and loans advanced to subsidiary undertakings. The Company seeks 
to minimise this risk by only depositing funds with banks with a high credit rating and through 
careful monitoring of the operations of subsidiaries (see C2.).

The maximum exposure to credit risk on the Company financial assets is represented by their 
carrying amounts as outlined in the categorisation of financial instruments table below.

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102

TISSUE REGENIX GROUP PLCANNUAL REPORT AND ACCOUNTS FOR THE YEAR ENDED 31 DECEMBER 2020 
 
 
  
 
 
 
 
 
 
 
The Company had cash and cash equivalents at each reporting date is set out below.

Cash and cash equivalents

A+

A

A-

2020
£000

515

8,445

79

9,039

2019
£000

1,000

669

–

1,669

The above has been split by the Fitch rating system and gives an analysis of the credit rating of the 
financial institutions where cash balances are held.

Management of liquidity risk
The Company seeks to manage liquidity risk to ensure that sufficient funding is available to meet 
foreseeable needs and to invest cash assets safely and profitably.

No maturity analysis for financial liabilities is presented, as the Directors consider that liquidity risk 
is not material. 

Capital risk management

The Company manages its capital to ensure that the Company will be able to continue as a 
going concern while maximising the return to stakeholders. The Company’s overall strategy is to 
minimise costs and liquidity risk.

The capital structure of the Company consists of equity attributable to the owners of the 
Company, comprising issued capital, reserves and retained earnings as disclosed in note 20 and in 
the Statement of Changes in Equity.

Categorisation of financial instrument

Financial assets/(liabilities)

Financial assets/(liabilities)

At 31 December 2020

Trade and other receivables

Cash and cash equivalents

Intercompany loans

Trade and other payables

Financial assets/(liabilities)

At 31 December 2019

Trade and other receivables

Cash and cash equivalents

Intercompany loans

Trade and other payables

Financial 
assets at 
amortised
cost
£000

Financial 
liabilities at 
amortised
cost
£000

4

9,039

11,754

–

20,797

–

–

–

(244)

(244)

Financial 
assets at 
amortised
cost
£000

Financial 
liabilities at 
amortised
cost
£000

196

1,669

20,617

–

22,482

–

–

–

(482)

(482)

Total
£000

4

9,039

11,754

(244)

20,553

Total
£000

196

1,669

20,617

(482)

22,000

103

FINANCIAL STATEMENTS0
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C9. Share based payments
Other Share Options
A credit has been recognised in the statement of comprehensive income for the year as follows:

At 31 December 2019

Credit in respect of employment related share options

At 31 December 2020

Share based 
payment 
reserves  
£000

910

(3)

907

C10. Related party transactions
Remuneration received by the key management personnel which includes directors and senior 
management (including Employers NI) from the Group is set out below:

Short-term employment benefits

2020
£000

946

2019
£000

836

Intercompany loans during and at the end of the year, before provisions for expected credit losses 
of £64,132k (2019: £49,910k) were as follows:

At 31 December 2018

(Repayment)/Advance in the 
year

At 31 December 2019

(Repayment)/Advance  
in the year

At 31 December 2020

Impairment provision:

At 31 December 2018

At 31 December 2019

At 31 December 2020

Tissue 
Regenix 
Limited

43,880

3,579

47,459

5,598

53,057

(1,310)

(39,267)

(50,765)

TRx 
Cardiac
Limited

TRx 
Orthopedics
Limited

TRx 
Wound
Care 
Limited

Total

147

27

174

(18)

156

–

–

–

3,745

17,906

65,678

(309)

3,436

(145)

3,291

724

18,630

(76)

18,554

4,021

69,699

5,359

75,058

–

–

–

–

(1,310)

(10,000)

(49,267)

(12,626)

(63,391)

The Company has entered into a number of unsecured related party transactions with its 
subsidiary undertakings. The most significant transactions carried out between the Company and 
its subsidiary undertakings are mainly for short and long-term financing. The company also has a 
loan with the Employee Benefit Trust of £828,000 (2019: £828,000) against which an impairment 
provision of £741,000 has been recorded (2019: £643,000). This is included as a debtor as there is a 
contractual loan agreement between the Company and the Trust.

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104

TISSUE REGENIX GROUP PLCANNUAL REPORT AND ACCOUNTS FOR THE YEAR ENDED 31 DECEMBER 2020 
 
 
  
 
 
 
 
 
 
 
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IMPORTANT INFORMATION REGARDING 
COVID-19 AND THE AGM
The COVID-19 pandemic and the related 
guidelines and measures implemented 
by governmental authorities will clearly 
impact the ability of shareholders to attend 
the AGM.

G TISSUE REGENIX GROUP PLC
N
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G

Our preference had been to welcome 
shareholders in person to the AGM, particularly 
given the constraints we faced in 2020 due to 
the COVID-19 pandemic. However, at the time 
of writing of this Notice, it is expected that 
there will still be limitations on our ability to 
host shareholders at the AGM. We therefore 
strongly recommend that shareholders do 
not attend the AGM in person and instead 
appoint the Chairman of the meeting to act 
as their proxy. Due to the expected restrictions 
applicable at that time, shareholders may not 
be permitted to attend the physical location 
for the AGM in person or, if attendance at the 
venue is permissible at the relevant time, it is 
likely to be restricted in terms of numbers. We 
would therefore still encourage shareholders 
not to attend the venue in person and instead 
appoint the Chairman of the meeting to act 
as their proxy. If any shareholders do intend to 
attend the meeting in person, the Company 
strongly encourages them to advise the 
Company at least 48 hours in advance of 
the AGM by using the contact details below. 
Any such communication shall not provide a 
guarantee that admittance to the AGM will be 
permitted where to do so would be in breach 
of rules governing public gatherings and/or the 
need to protect the health and safety of those 
already in the meeting.

The Board’s instructions are subject to change, 
depending on guidelines and measures 
implemented by governmental authorities, 
and any changes to such instructions will be 
communicated to shareholders.

TISSUE REGENIX GROUP PLC
NOTICE OF ANNUAL GENERAL MEETING
Notice is given that the 2021 Annual General 
Meeting of Tissue Regenix Group plc 
(“Company”) will be held at DLA Piper, Princes 
Exchange, Princes Square, Leeds LS1 4BY on 
3 June 2021 at 12.00 p.m. for the following 
purposes:

To consider and, if thought fit, to pass the 
following resolutions as ordinary resolutions:

1. 

2. 

3. 

4. 

5. 

6. 

7. 

8. 

9. 

 To receive the Company’s annual 
accounts, strategic report and directors’ 
and auditors’ reports for the year ended 
31 December 2020.

 To reappoint Jonathan Glenn who retires 
by rotation, as a director of the Company. 

 To reappoint Shervanthi Homer-
Vanniasinkam who retires by rotation, as 
a director of the Company.

 To reappoint Daniel Lee as a director of 
the Company, who has been appointed 
by the Board since the last Annual 
General Meeting, as a director of the 
Company.

 To reappoint David Cocke as a Director of 
the Company, who has been appointed 
by the Board since the last Annual 
General Meeting, as a director of the 
Company.

 To reappoint Brian Phillips as a Director of 
the Company, who has been appointed 
by the Board since the last Annual 
General Meeting, as a director of the 
Company.

 To reappoint Trevor Phillips as a 
Director of the Company, who has been 
appointed by the Board since the last 
Annual General Meeting, as a director of 
the Company.

 To reappoint RSM UK Audit LLP as 
Auditors of the Company. 

 To authorise the directors to determine 
the remuneration of the Auditors.

105

FINANCIAL STATEMENTS 
 
  
 
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10. 

 That, pursuant to section 551 of the 
Companies Act 2006 (“Act”), the directors 
be generally and unconditionally 
authorised to allot Relevant Securities:

10.1 

 Up to an aggregate nominal amount of 
£2,344,359; and

10.2 

 Comprising equity securities (as defined 
in section 560(1) of the Act) up to a 
further aggregate nominal amount of 
£2,344,359 in connection with an offer by 
way of a rights issue:

10.2.1 

10.2.2 

 to holders of ordinary shares 
in the capital of the Company 
in proportion (as nearly as 
practicable) to the respective 
numbers of ordinary shares held 
by them; and

 to holders of other equity 
securities in the capital of the 
Company, as required by the 
rights of those securities or, 
subject to such rights, as the 
directors otherwise consider 
necessary,

 but subject to such exclusions or other 
arrangements as the directors may deem 
necessary or expedient in relation to 
treasury shares, fractional entitlements, 
record dates or any legal or practical 
problems under the laws of any territory 
or the requirements of any regulatory 
body or stock exchange, provided that 
these authorities shall expire at the 
conclusion of the next Annual General 
Meeting of the Company after the 
passing of this resolution or on 27 August 
2022 (whichever is the earlier), save that, 
in each case, the Company may make an 
offer or agreement before the authority 
expires which would or might require 
Relevant Securities to be allotted after 
the authority expires and the directors 
may allot Relevant Securities pursuant 
to any such offer or agreement as if the 
authority had not expired.

 In this resolution, “Relevant Securities” 
means shares in the Company or rights 
to subscribe for or to convert any security 
into shares in the Company; a reference 
to the allotment of Relevant Securities 
includes the grant of such a right; and 
a reference to the nominal amount of 
a Relevant Security which is a right to 
subscribe for or to convert any security 
into shares in the Company is to the 
nominal amount of the shares which may 
be allotted pursuant to that right.

 These authorities are in substitution for 
all existing authorities under section 551 
of the Act (which, to the extent unused 
at the date of this resolution, are revoked 
with immediate effect).

To consider and, if thought fit, to pass the 
following resolutions as special resolutions:

11. 

11.1 

 That, subject to the passing of resolution 
10 and pursuant to section 570 of the 
Act, the directors be and are generally 
empowered to allot equity securities 
(within the meaning of section 560 of the 
Act) for cash pursuant to the authority 
granted by resolution 10 as if section 
561(1) of the Act did not apply to any such 
allotment, provided that this power shall 
be limited to the allotment of equity 
securities:

 In connection with an offer of equity 
securities (whether by way of a rights 
issue, open offer or otherwise, but, in 
the case of an allotment pursuant to the 
authority granted by paragraph 10.2 of 
resolution 10, such power shall be limited 
to the allotment of equity securities in 
connection with an offer by way of a 
rights issue):

11.1.1 

11.1.2 

 to holders of ordinary shares 
in the capital of the Company 
in proportion (as nearly as 
practicable) to the respective 
numbers of ordinary shares held 
by them; and

 to holders of other equity 
securities in the capital of the 
Company, as required by the 
rights of those securities or, 
subject to such rights, as the 
directors otherwise consider 
necessary,

 but subject to such exclusions or other 
arrangements as the directors may deem 
necessary or expedient in relation to 
treasury shares, fractional entitlements, 
record dates or any legal or practical 
problems under the laws of any territory 
or the requirements of any regulatory 
body or stock exchange; and

11.2 

 Otherwise than pursuant to paragraph 
1.1 of this resolution up to an aggregate 
nominal amount of £703,307,

 and this power shall expire at the 
conclusion of the next Annual General 
Meeting of the Company after the 
passing of this resolution or on 27 August 
2022 (whichever is the earlier), save that 
the Company may make an offer or 
agreement before this power expires 
which would or might require equity 
securities to be allotted for cash after this 
power expires and the directors may allot 
equity securities for cash pursuant to any 
such offer or agreement as if this power 
had not expired.

 This power is in substitution for all 
existing powers under section 570 of the 
Act (which, to the extent unused at the 
date of this resolution, are revoked with 
immediate effect).

TISSUE REGENIX GROUP PLCANNUAL REPORT AND ACCOUNTS FOR THE YEAR ENDED 31 DECEMBER 2020 
 
 
 
 
 
 
 
 
 
 
 
  
 
12. 

 That, pursuant to section 701 of the Act, 
the Company be and is generally and 
unconditionally authorised to make 
market purchases (within the meaning 
of section 693(4) of the Act) of ordinary 
shares of 0.1p each in the capital of the 
Company (“Shares”), provided that:

12.1 

 The maximum aggregate number of 
Shares which may be purchased is 
703,307,749;

12.2 

 The minimum price (excluding expenses) 
which may be paid for a Share is 0.1p;

12.3 

 The maximum price (excluding expenses) 
which may be paid for a Share is an 
amount equal to 105% of the average 
of the middle market quotations for a 
Share as derived from the Daily Official 
List of the London Stock Exchange plc 
for the five business days immediately 
preceding the day on which the purchase 
is made; 

 and (unless previously revoked, varied or 
renewed) this authority shall expire at the 
conclusion of the next Annual General 
Meeting of the Company after the 
passing of this resolution or on 27 August 
2022 (whichever is the earlier), save that 
the Company may enter into a contract 
to purchase Shares before this authority 
expires under which such purchase will 
or may be completed or executed wholly 
or partly after this authority expires and 
may make a purchase of Shares pursuant 
to any such contract as if this authority 
had not expired.

By order of the board

Kirsten Lund
Secretary

26 April 2021

Registered office: Unit 3, Phoenix Court, 
Lotherton Way, Garforth, Leeds, England, 
LS25 2GY
Registered in England and Wales No. 
05969271

Notes

Entitlement to attend and vote

1. 

 The right to vote at the meeting is 
determined by reference to the register 
of members. Only those shareholders 
registered in the register of members of the 
Company as at the close of business on 25 
May 2021 (or, if the meeting is adjourned, 
close of business on the date which is 
two working days before the date of the 
adjourned meeting) shall be entitled to 
attend and vote at the meeting in respect 
of the number of shares registered in their 
name at that time. Changes to entries in 
the register of members after that time 

2. 

shall be disregarded in determining the 
rights of any person to attend or vote (and 
the number of votes they may cast) at the 
meeting.

 In light of the spread of COVID-19 in the 
UK and associated measures put in place 
by the UK Government, the Company 
encourages shareholders not to attend the 
meeting in person. Instead, shareholders 
who wish to vote are encouraged to 
complete a form of proxy, appointing the 
chairman of the meeting as their proxy, in 
accordance with the instructions in notes 
3-5 below. Shareholders are advised that, 
if they attempt to attend the meeting in 
person, they may be denied entry to the 
venue.

Proxies
3. 

 A shareholder is entitled to appoint another 
person as his or her proxy to exercise all 
or any of his or her rights to attend and to 
speak and vote at the meeting. A proxy 
need not be a shareholder of the Company.

 A shareholder may appoint more than one 
proxy in relation to the meeting, provided 
that each proxy is appointed to exercise 
the rights attached to a different share or 
shares held by that shareholder. Failure to 
specify the number of shares each proxy 
appointment relates to or specifying a 
number which when taken together with 
the numbers of shares set out in the other 
proxy appointments is in excess of the 
number of shares held by the shareholder 
may result in the proxy appointment being 
invalid.

 A proxy may only be appointed in 
accordance with the procedures set out in 
notes 4 and 5 below and the notes to the 
proxy form.

 The appointment of a proxy will not 
preclude a shareholder from attending and 
voting in person at the meeting.

4. 

 You can vote either:

 ▶ by logging on to www.signalshares.com and 

following the instructions;

 ▶ You may request a hard copy form of proxy 
directly from the registrars, Link Group 
(previously called Capita), on Tel: 0371 664 
0300. Calls are charged at the standard 
geographic rate and will vary by provider. 
Calls outside the United Kingdom will be 
charged at the applicable international 
rate. Lines are open between 09:00 - 17:30, 
Monday to Friday excluding public holidays 
in England and Wales).

 ▶ in the case of CREST members, by utilising 
the CREST electronic proxy appointment 
service in accordance with the procedures 
set out below.

107

FINANCIAL STATEMENTS 
 
 
 
In order for a proxy appointment to be valid 
a form of proxy must be completed. In each 
case the form of proxy must be received by 
Link Group at 10th Floor, Central Square, 29 
Wellington Street, Leeds, LS1 4DL by 12.00pm 
on 1 June 2021.

 5. 

 CREST members who wish to appoint a 
proxy or proxies for the meeting (or any 
adjournment of it) through the CREST 
electronic proxy appointment service may 
do so by using the procedures described 
in the CREST Manual. CREST personal 
members or other CREST sponsored 
members, and those CREST members who 
have appointed a voting service provider(s), 
should refer to their CREST sponsor or 
voting service provider(s), who will be able to 
take the appropriate action on their behalf.

 In order for a proxy appointment or 
instruction made using the CREST service 
to be valid, the appropriate CREST message 
(a “CREST Proxy Instruction”) must be 
properly authenticated in accordance 
with Euroclear UK & Ireland Limited’s 
specifications and must contain the 
information required for such instructions, 
as described in the CREST Manual. 
The message, regardless of whether it 
constitutes the appointment of a proxy or 
is an amendment to the instruction given 
to a previously appointed proxy, must, in 
order to be valid, be transmitted so as to 
be received by Link Group (ID RA10) no 
later than 12.00 p.m. on 1 June 2021 (or, if 
the meeting is adjourned, no later than 48 
hours before the time of any adjourned 
meeting). For this purpose, the time of 
receipt will be taken to be the time (as 
determined by the timestamp applied to 
the message by the CREST Applications 
Host) from which Link Group is able to 
retrieve the message by enquiry to CREST 
in the manner prescribed by CREST. After 
this time, any change of instructions to 
proxies appointed through CREST should 
be communicated to the appointee 
through other means.

 CREST members and, where applicable, 
their CREST sponsors or voting service 
providers should note that Euroclear 
UK & Ireland Limited does not make 
available special procedures in CREST for 
any particular messages. Normal system 
timings and limitations will therefore apply 
in relation to the input of CREST Proxy 
Instructions. It is the responsibility of the 
CREST member concerned to take (or, if 
the CREST member is a CREST personal 
member or sponsored member or has 
appointed a voting service provider(s), 
to procure that his or her CREST sponsor 
or voting service provider(s) take(s) such 
action as shall be necessary to ensure that 
a message is transmitted by means of the 

CREST system by any particular time. In this 
connection, CREST members and, where 
applicable, their CREST sponsors or voting 
service providers are referred, in particular, 
to those sections of the CREST Manual 
concerning practical limitations of the 
CREST system and timings.

 The Company may treat a CREST Proxy 
Instruction as invalid in the circumstances 
set out in Regulation 35(5)(a) of the 
Uncertificated Securities Regulations 2001.

Corporate representatives
6. 

 A shareholder which is a corporation may 
authorise one or more persons to act 
as its representative(s) at the meeting. 
Each such representative may exercise 
(on behalf of the corporation) the same 
powers as the corporation could exercise if 
it were an individual shareholder, provided 
that (where there is more than one 
representative and the vote is otherwise 
than on a show of hands) they do not do so 
in relation to the same shares.

Documents available for inspection
7. 

 Subject to the restrictions imposed as a 
result of the spread of COVID-19 in the UK, 
the following documents will be available 
for inspection during normal business 
hours at the registered office of the 
Company from the date of this notice until 
the time of the meeting. They will also be 
available for inspection at the place of the 
meeting from at least 15 minutes before the 
meeting until it ends:

7.1   Copies of the service contracts of the 

Executive Directors.

7.2   Copies of the letters of appointment of the 

Non-Executive Directors.

Biographical details of directors
8. 

 Biographical details of all those directors 
who are offering themselves for 
reappointment at the meeting are set out 
on pages 50 and 51 of the enclosed Annual 
Report and Accounts.

Share capital
9. 

 As at 27 April 2021 (the last practicable 
business day prior to the date of this 
notice), the Company’s issued share capital 
comprised 7,033,077,499 ordinary shares 
of 0.1 pence each and 1,171,971,322 deferred 
shares of 0.4 pence each. Each ordinary 
share carries the right to vote at a general 
meeting of the Company. The deferred 
shares carry no voting rights. Therefore, the 
total number of voting rights as at the date 
of this document is 7,033,077,499. 

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TISSUE REGENIX GROUP PLCANNUAL REPORT AND ACCOUNTS FOR THE YEAR ENDED 31 DECEMBER 2020 
 
  
 
 
 
 
Non-Executive Chairman

Chief Executive Officer

Chief Financial Officer

Shervanthi Homer-Vanniasinkam  Non-Executive Director

Jonathan Glenn 

Daniel Lee 

S DIRECTORS
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David Cocke 

I

Brian Phillips 

Trevor Phillips 

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Non-Executive Director

Non-Executive Director

REGISTRAR
Link Group
PXS 1
Link Group
Central Square
29 Wellington Street 
Leeds
LS1 4DL

LEGAL ADVISERS
DLA Piper UK LLP 
Princes Exchange 
Princes Square 
Leeds 
LS1 4BY

Squire Patton Boggs UK LLP
6 Wellington Place  
Leeds
LS1 4AP

COMPANY SECRETARY
Kirsten Lund 

COMPANY WEBSITE
www.tissueregenix.com

COMPANY NUMBER
05969271 (England & Wales)

REGISTERED OFFICE 
Unit 3 
Phoenix Court 
Lotherton Way 
Garforth 
LS25 2GY 

AUDITOR 
RSM UK Audit LLP 
Central Square 
29 Wellington Street 
Leeds 
LS1 4DL 

NOMINATED ADVISER  
AND BROKER
Stifel Nicolaus Europe Ltd
150 Cheapside 
London
EC2V 6ET

 
  
 
 
 
 
 
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Tissue Regenix Group plc

Unit 3, 
Phoenix Court,  
Lotherton Way,  
Garforth,  
LS25 2GY

www.tissueregenix.com