Perivan.com
Polarean Imaging Plc
Group Annual Report & Accounts 2022
Company Number 10442853
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Group Annual Report and Financial Statements
for the year ended 31 December 2022
Contents
Company Information
Company Information
Chairman’s Statement
Chairman’s Statement
Chief Executive Officer’s Statement
Chief Executive Officer’s Statement
Strategic Report
Strategic Report
Directors’ Report
Directors’ Report
Corporate Governance Statement
Corporate Governance Statement
Remuneration Committee Report
Remuneration Committee Report
Independent Auditors’ report to the members of Polarean Imaging plc
Independent Auditors’ report to the members of Polarean Imaging plc
Consolidated Statement of Comprehensive Income
Consolidated Statement of Comprehensive Income
Consolidated Statement of Financial Position
Consolidated Statement of Financial Position
Company Statement of Financial Position
Company Statement of Financial Position
Consolidated Statement of Changes in Equity
Consolidated Statement of Changes in Equity
Company Statement of Changes in Equity
Company Statement of Changes in Equity
Consolidated Statement of Cash Flows
Consolidated Statement of Cash Flows
Company Statement of Cash Flows
Company Statement of Cash Flows
Notes to the Financial Statements
Notes to the Financial Statements
Notice of the Annual General Meeting
Notice of the Annual General Meeting
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Directors
Group Annual Report and Financial Statements
for the year ended 31 December 2022
Company Information
Kenneth West Non-Executive Chairman
Richard Hullihen Chief Executive Officer
Charles Osborne Chief Financial Officer
Bastiaan Driehuys, PH.D. Chief Technology Officer
Jonathan Allis, PH.D. Non-Executive Director
(resigned 4 May 2022)
Daniel Brague Non-Executive Director
(appointed 4 May 2022)
Juergen Laucht Non-Executive Director
Cyrille Petit Non-Executive Director
Frank Schulkes Non-Executive Director
Marcella Ruddy, M.D. Non-Executive Director
(appointed 13 April 2022)
(appointed 25 August 2022)
Company Secretary
Stephen Austin
Registered Office
27-28 Eastcastle Street
London, W1W 8DH
Company Number
Registered in England and Wales Number 10442853
Nominated Adviser and Broker
Independent Auditor
Registrars
Principal Banker
Legal Advisers to the Company
Financial Public Relations
and Investor Relations
Independent Expert
Stifel Nicolaus Europe Limited
150 Cheapside
London
EC2V 6ET
Crowe U.K. LLP
55 Ludgate Hill
London
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Share Registrars Limited
Suite E, First Floor
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The Broadgate Tower
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London
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Pharma Ventures Limited
1300 Parkway Court
John Smith Drive
Oxford Business Park South
Oxford
OX4 2JY
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Group Annual Report and Financial Statements
for the year ended 31 December 2022
Chairman’s Statement
I am pleased to be able to write this letter with the very important milestone of United States Food &
Drug Administration (“FDA”) approval of the Company’s drug device combination product, XENOVIEW,
having been accomplished. The broad label of “evaluation of lung ventilation in adults and pediatric
patients aged 12 years and older” allows the company to execute its commercial strategy of selling its
polarizer and approved gas for clinical scans of patients suffering from a number of lung diseases where
the accurate measurement of lung ventilation provides the physician with actionable diagnostic
information. In addition, researchers using Polarean’s technology continue to conduct clinical research
that supports the broad future potential applications of our technology in areas of gas exchange and
cardiopulmonary diagnostics. We are excited to bring Polarean’s technology to clinical medicine, with the
potential to be an important part of pulmonary and cardiopulmonary diagnostics, monitoring of severity
of disease and patient response to treatments.
During 2022, we strengthened our Board with the addition of three independent Non-Executive Board
members who bring extensive industry and medical experience to the Board to assist the company’s
successful transition into the commercialization stage. Frank Schulkes brings substantial financing
experience in the medical imaging industry and Dan Brague brings experience successfully
commercializing diagnostic imaging products. In addition, Dr. Marcella Ruddy brings important pulmonary
medical expertise, both in clinical practice and in pharmaceutical development. With these additions to
our Board, we believe that we have a world-class Board that can lead the company to successful
commercialization of Xenoview.
Having achieved FDA approval, our efforts are now focused on gaining commercial traction and engaging
with potential corporate partners to further accelerate our commercial success. Once we have achieved
some of these near-term milestones, we will explore the options for additional financing to more
aggressively pursue the development of the next indications and advance the continued development
of our polarizer system and software. The Company is exploring a broad range of options for future
financing, including equity raises and corporate partnering.
On behalf of the Board, I want to thank our employees, stakeholders and shareholders and assure them
that we are committed to making Xenoview a commercial and financial success.
Kenneth West
Non-Executive Chairman
25 May 2023
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Group Annual Report and Financial Statements
for the year ended 31 December 2022
Chief Executive Officer’s Statement
2022 – Year of Obtaining FDA Approval
We spent much of 2022 working on obtaining FDA approval of our New Drug Application (“NDA”) for
XENOVIEW and were please received our approval on 23 December 2022. After receiving a Complete
Response Letter (“CRL”) from the FDA in October 2021, we spend the subsequent six months addressing
the issues raised in the CRL. On 30 March 2022, the Company refiled the NDA with the FDA. The
resubmission addressed the items identified in the CRL. On 22 September the Company announced
that the FDA had requested additional information related to the cGMP (Current Good Manufacturing
Practice) pre-approval inspection at the partner’s production facility. The Company and its partner
addressed the FDA’s request and the Company received FDA approval on 23 December 2022. We were
very pleased to receive the broad label of evaluation of lung function in adults and pediatric patients
twelve and older. In addition, the FDA indicated that they would allow us to submit a non-clinical plan to
obtain approval in pediatric patients six and older. The FDA has granted New Chemical Entity (“NCE”)
designation for Xenoview. NCE designation provides the important first mover protection envisioned
under the Hatch Waxman legislation.
Commercialization
With FDA approval, the Company is focused on successful commercialization of XENOVIEW for the
evaluation of lung function. The Company has an enthusiastic base of US institutions who have been
using our technology for research purposes for years. We are leveraging this knowledge and enthusiasm
by converting its US research sites to FDA approved configuration and clinical use, which will allow these
sites to purchase Xenoview and perform clinical scans. In parallel, we are pursuing various reimbursement
codes that could enable the hospitals to be reimbursed for Xenoview, the polarization process, the MRI
procedure and the analysis of the pulmonary function imaging. If obtained, we believe that this
reimbursement would enable a very compelling return on investment for hospitals to purchase our polarizer
systems. We are aggressively pursuing our early commercialization targets of the sale of 15 to 20 polariser
systems and 75 to 100 cylinders of Xenoview by the end of 2024.
We are focusing initially on addressing the high end of the US academic and teaching hospital market
segment, which comprises approximately the top 1000 institutions nationally having coincident multiple
Centres of Excellence in Pulmonary Medicine and Radiology. We believe our strategy of selling the
capital equipment and the Xenoview drug on a per cylinder basis could provide a capital equipment and
recurring drug sales model that supports rapidly growing revenue.
Financials
Sales for 2022 were below our original expectations, as we did not receive FDA approval in October 2022
as anticipated in the plan. We adjusted our spending plans commensurate with the delayed approval,
which allowed us to finish 2022 with a higher than anticipated cash balance of US$16.4 million. We
continued to sell our polariser systems into the research market and completed two installations during
2022. The current cash balance is expected to fund the company into late Q2-2024.
Corporate Partnering
We continue to believe that corporate partnering could be an important part of the Company’s business
plan. We see the opportunity to help the pharmaceutical industry reduce by significant amounts the size,
time required to conduct and costs of their pulmonary drug clinical trials by providing quantitative,
reproducible image-based data. We also see the opportunity to partner with MRI manufacturers to open
up the MRI applications space to include pulmonary diagnostics, driving the demand for more MRI
systems. In addition, we will explore the opportunity to partner with pulmonary disease organizations and
foundations to incorporate the use of Xenoview in the diagnosis and treatment of disease.
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Group Annual Report and Financial Statements
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Chief Executive Officer’s Statement (continued)
Future Indications
Researchers are currently conducting clinical trials and pharmaceutical company sponsored
investigations in multiple areas of pulmonary disease using our technology. These studies are highlighting
the exciting opportunities in the areas of long COVID and cardiopulmonary vascular disease. We believe
that these areas could greatly expand the total addressable markets and use of the Company’s
technology in the future.
2023 and Beyond
As discussed above, we are focused on achieving early commercial traction with our broad lung function
evaluation label granted by the FDA in late 2022. In parallel, we are exploring a variety of partnering
opportunities. Once we have achieved some of these near-term milestones, we will explore the
appropriate timing and structure to finance the continued commercial efforts, clinical trials to seek
approval for the high-value gas exchange and pulmonary vascular disease indications and continue to
improve our polariser system and imaging software.
This important milestone of FDA approval would not have been possible without the dedicated team of
employees, consultants and advisers working to bring our much needed technology to clinicians, their
patients and the institutions enabling their care. I thank everyone for their hard work in accomplishing
this significant achievement.
Richard Hullihen
Chief Executive Officer
25 May 2023
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Group Annual Report and Financial Statements
for the year ended 31 December 2022
Strategic Report
1. Introduction
The Group comprises medical drug-device combination companies operating in the high-resolution
medical imaging market. The Group develops equipment that enables existing MRI systems to achieve
an improved level of pulmonary functional imaging and specialises in the use of polarised xenon gas
(129Xe ) as an imaging agent to visualise ventilation (the ability of air to reach the alveoli) and gas
exchange (the ability of oxygen to diffuse through the alveolar membrane into the pulmonary vasculature)
regionally down to the smallest airways of the lungs, the tissue barrier between the lung and the
bloodstream and in the pulmonary vasculature; and now also microvascular haemodynamics within the
lung, a novel diagnostic approach. The Group will also register and sell the high-performance
MRI radiofrequency (RF) coils which are a required component for imaging 129Xe in the MRI system.
Providing access to these coils facilitates the adoption of the Xenon technology by providing
application-specific RF coils which optimise the imaging of 129Xe in MRI equipment.
The Group was formed on 31 May 2017 when the Company acquired Polarean, Inc (the “Subsidiary”).
The Subsidiary was formed as a result of two mergers: the first between Polarean Merger-Sub Inc. and
m2m, a company that the Subsidiary had developed a relationship with during the course of previous
research and commercialisation programmes in the US and the second between m2m and the
Subsidiary. m2m was previously a portfolio company of Amphion Innovations plc (“Amphion”), a developer
of medical, life science, and technology businesses, which is itself currently listed on AIM.
2. Investment Case
Pulmonary disease currently affects hundreds of millions of people globally, including approximately
174 million people who suffer from Chronic Obstructive Pulmonary Disease (“COPD”), which is
responsible for approximately 6% of such deaths globally each year. In the US more than 30 million
people suffer from a chronic lung disease such as COPD, which includes emphysema, chronic bronchitis
and asthma. In addition to its significant human toll, pulmonary disease also represents an economic
burden in excess of US$150 billion annually in the US alone.
Every type of pulmonary disease involves some combination of ventilation and/or gas exchange
impairment, yet the successful and cost-effective treatment of lung disease is hampered by sub-optimal
methods for quantifying pulmonary ventilation and gas exchange. Current diagnostic techniques are
either imprecise (such as spirometry) and/or expose the patient to potentially dangerous radiation (such
as x-rays, CT scans and nuclear scintigraphy). While spirometry has benefits as a screening tool, none
of these current methods can visualise ventilation or gas exchange regionally in the smallest airways,
where lung disease typically begins and where improvements from new pharmaceutical therapies can
first be detected.
As such, the Group operates in an area of significant unmet medical need and is pursuing approval by
the US Food & Drug Administration (“FDA”) for the Group’s drug-device combination product using
hyperpolarised xenon-129 gas to enhance MRI in pulmonary medicine. The Company submitted a new
drug application (“NDA”) to the FDA on 5 October 2020 after the successful completion of the FDA Phase
III clinical trials in the US for the Group’s technology. The 80-patient equivalence clinical trials were
conducted at Duke University Medical Center, the University of Virginia and The University of Cincinnati -
three leading US research hospitals. Enrolment of the clinical trials was completed in November 2019.
In January 2020, the Company announced that both clinical trials met their primary endpoints, within the
prospectively defined equivalence margin (+/-14.7%) when compared to the FDA-approved reference
standard, 133Xenon scintigraphy imaging. On 5 October 2021, the Company received a Complete
Response Letter (“CRL”) from the FDA requesting that the Company to address approvability issues
identified by the FDA ahead of NDA resubmission. On 30 March 2022, the Company filed the
resubmission of the NDA with the FDA. On 20 April 2022, the Company announced that the FDA had
accepted the resubmission of the NDA and established a user fee goal date of 30 September 2022.
On 30 September 2022, the Company announced that the FDA had granted the Company a 90 day
extension to the NDA review timeline. On 28 December 2022, the Company announced that the FDA had
granted approval for its drug device combination product, XENOVIEW. XENOVIEW, prepared from the
Xenon Xe 129 Gas Blend, is a hyperpolarised contrast agent indicated for use with magnetic resonance
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Group Annual Report and Financial Statements
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Strategic Report (continued)
imaging ("MRI") for evaluation of lung ventilation in adults and pediatric patients aged 12 years and older.
On 28 December 2022, the Company also announced that, simultaneously with the approval of the
XENOVIEW NDA, two 510(k) devices were cleared by the FDA that will further support a successful
launch of the technology into the clinical marketplace: XENOVIEW VDP software and the
XENOVIEW 3.0T Chest Coil. XENOVIEW VDP is image processing software that analyzes a pulmonary
hyperpolarised 129-Xe MR image and a proton chest MR image to provide visualization and evaluation
of lung ventilation in adults and pediatric patients aged 12 years and older. This image analysis platform
quantifies normalized xenon intensity of a ventilated space using a pulmonary hyperpolarised 129-Xe
ventilation MR image and accompanying proton chest MR image. The software will be used by clinicians
to assist in the interpretation and numerical classification of hyperpolarized 129-Xe ventilation MR images.
The Polarean XENOVIEW 3.0T Chest Coil is a flexible, single channel, transmit-receive (T/R) RF coil
tuned to 129Xe frequency on a 3.0T MRI magnetic field of a compatible MRI scanner. The Polarean
XENOVIEW 3.0T Chest Coil is indicated to be used in conjunction with compatible 3.0T MRI scanners
and approved xenon Xe 129 hyperpolarised for oral inhalation for evaluation of lung ventilation in adults
and pediatric patients aged 12 years and older. The Chest Coil is intended to be worn by a patient who
inhales hyperpolarised 129Xe gas (XENOVIEW) to obtain an MR image of the regional distribution of
hyperpolarised 129Xe in the lungs.
The Group’s technology overcomes important limitations of current lung diagnostic methods, providing
the ability to visualise, quantify and monitor both the structure and function of the smallest airways and
alveolar spaces with enhanced sensitivity and without harmful radiation. This provides a unique, valuable
and more precise tool to help diagnose disease earlier, identify the type of intervention likely to benefit a
patient, monitor the efficacy of treatment and facilitate developing new therapies for pulmonary diseases.
3. Group Structure and History
The Company was incorporated in England and Wales on 24 October 2016 with company registration
number 10442853. The Company’s registered office is 27-28 Eastcastle Street, London, W1W 8DH.
On 31 May 2017, m2m, a company formed in the US State of Delaware on 18 February 1999, was
merged into the Company.
On 29 March 2018, the Company’s shares were admitted to trading on the AIM market of the London
Stock Exchange.
4. Information on Polarean, m2m and Strategy of Group
4.1 Polarean, Inc. – Background
The Subsidiary was co-founded by Dr Bastiaan Driehuys, a current Director of the Company, and
John Sudol, a former director of the Subsidiary, in 2011. Prior to co-founding the Subsidiary,
Dr Driehuys was a member of a research team at Princeton University in the early 1990s which
was amongst the first research teams to focus on hyperpolarised gas MRI technology; in particular
isotopically enriched helium (3He). The team developed and held key patents relating to the
technology. The technology was acquired in 1999 by Amersham, Inc. (“Amersham”), with the goal of
commercialising hyperpolarised helium products to be marketed and distributed alongside
Amersham’s full line of contrast agent products. Dr Driehuys led the development efforts for
Amersham, which continued the development of these hyperpolarised helium products throughout
the early 2000s until GE Healthcare (“GE”) acquired Amersham in 2004.
GE continued the research and development of hyperpolarised gas MRI after the acquisition of
Amersham, focusing on 129Xe as a more effective substitute for 3He in visualising ventilation. GE also
began to explore ways in which 129Xe could be used to image gas exchange within the lung in
addition to ventilation. These work programmes culminated in the conduct of a Phase I/II clinical
trial at Duke University in 2008-2009. GE also filed Investigational New Drug Applications (‘INDs”)
with the FDA for both 3He and 129Xe. By 2010, after an investment of approximately US$40 million
in the technology and with the regulatory path for hyperpolarised gas remaining unclear, GE decided
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Strategic Report (continued)
to out-license the hyperpolarised gas technology and the related patent families that it had
developed and/or maintained to the Subsidiary, due to the scale at the time and the early-stage
nature of the technology’s development.
In December 2011, the Subsidiary negotiated the acquisition of all of GE’s assets related to the
hyperpolarised MRI project, including an inventory of polarisers and parts and the licenses
(or outright ownership) of the related patent families.
Following the acquisition of GE’s hyperpolarisation assets, the Subsidiary focused on three key
objectives:
l building and selling polarisers to research users to generate operating revenue and to
disseminate the technology to academic research institutions that generate clinical data in
order to build additional interest in the technology;
l further developing the xenon hyperpolarisation technology in order to meet clinical use
specification requirements; and
l liaising with the FDA in order to clarify the FDA regulatory path under which the product could
achieve clearance to market for clinical use.
In July 2012, the US Congress passed the FDA Safety and Innovation Act and the Medical Gas
Act, which clarified and simplified the path under which hyperpolarised gas MRI technology could
be approved for clinical use by the FDA.
As a result of discussions between the Group and the FDA, the Directors believed that a clearer path
towards regulatory approval existed. As such, following listing our shares on the AIM market the Group
began conducting the clinical studies required for FDA approval to market. On 28 December 2022,
the Company announced that the FDA had granted approval for its drug device combination product,
XENOVIEW. XENOVIEW, prepared from the Xenon Xe 129 Gas Blend, is a hyperpolarised contrast
agent indicated for use with MRI for evaluation of lung ventilation in adults and pediatric patients aged
12 years and older.
Between January 2012 and May 2017, the Subsidiary generated over US$3.7 million of revenue
from selling polarisers to customers in Canada, Germany, the UK and the US for research use,
relating to both clinical (human) and pre-clinical (animal) applications. In addition, the Subsidiary
received additional funding of approximately US$2.5 million from Nukem and other Series
A investors. Prior to the m2m merger, the Subsidiary was also successful in receiving grant funding,
including a US$3 million grant awarded in April 2017 by the US National Heart, Lung and Blood
Institute (NHLBI) following a competitive application process (for which the research will be
conducted with its clinical collaborator, the Cincinnati Children’s Hospital) and a US$250,000 small
business research loan from the North Carolina Biotech Center in March 2017, which was also
awarded following a competitive application process.
4.2 The Group’s Technology and Products
The Subsidiary’s lead product has been designated as a drug-device combination by the FDA.
The Subsidiary’s product enables the visualisation of hyperpolarised 129Xe (“HPX”) through
MRI technology to help diagnose lung disease earlier, identify the type of intervention likely to benefit
a patient and to monitor the efficacy of treatment. As a result of the FDA’s drug-device designation,
the Subsidiary’s products will be approved and sold only for use with each other. The products are
currently being used at a number of research sites on a pre-FDA clearance basis to facilitate the
research and evaluation of lung function, to assist in making improved disease progression
assessment and to clearly visualise the effectiveness of several therapeutics which are under
development. The Group currently generates revenue from the sale of products within its 129Xe gas
hyperpolarisation platform.
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Strategic Report (continued)
Implementing the Group’s technology in a clinical setting is straightforward: prior to the MRI scan a
patient breathes in a small amount of inert HPX to provide an extremely strong MRI signal. This
transforms the MRI from a technology that is not applicable to the lungs into one that is able to
provide multiple images of the lung structure and function in one 10-20 second breath-hold.
HPX MRI overcomes the limitations of traditional pulmonary function testing as HPX MRI:
l is more accurate and reproducible than spirometry and other traditional pulmonary function
tests, enabling the detection and mapping of small and localised changes in lung ventilation
and gas exchange over time;
l provides regional information about lung disease without exposure to ionising radiation or
radioactivity; and
l assesses ventilation and gas exchange in the smallest airways, where disease often begins.
The Group’s technology works in conjunction with traditional MRI, transforming it into a powerful
diagnostic modality for the lung. The Group’s approach is to take 129Xe, an inert gas, and
hyperpolarise the nucleus to create an MRI signal which is approximately 100,000 times stronger
than a conventional MRI signal. When the MRI scan is undertaken, the HPX resonates at different
frequencies: (i) in the bronchioles and alveoli of the lung; (ii) in the barrier tissue of the lung; and
(iii) when dissolved in arterial blood in the pulmonary vasculature, thus providing information on
ventilation (the ability of air to reach the alveoli) and gas exchange (the ability of air to diffuse
through the alveolar membrane into the pulmonary vasculature). As all pulmonary diseases result
from impairments to the free flow of air through bronchioles, or from abnormal gas exchange
between the lung alveoli and the pulmonary vasculature, the images that result from HPX MRI scans
which have been executed using the Group’s technology can aid diagnosis, by enhancing the
physician’s ability to clearly identify issues with ventilation and gas exchange on a regional basis,
down to the smallest of airways. Hyperpolarisation of the 129Xe is accomplished by placing a non-
radioactive isotope of Xenon (129Xe) into a beam of circularly polarised laser light in the presence
of very small concentration of the alkali metal Rubidium, which acts as a physical catalyst in the
hyperpolarisation process. The result is 129Xe whose nuclear magnetic spin is highly aligned but not
chemically or biologically different than unpolarised 129Xe, an inert gas. This hyperpolarised state
persists for around 2 hours allowing ample time to administer the HPX to the patient.
The Group’s products include:
l the 129Xe gas, blended and made under GMP at high purity, to be polarised within the polariser;
l the polariser itself, of which the latest model, the Polarean 9820 Xenon Hyperpolariser, has
been designed to deliver up to 3 litres of HPX per hour (approximately 5-10 doses) of which
each dose is to be used within 30 minutes of its production in order to retain sufficient
polarisation to create a strong image;
l the dose delivery inhalation bag, made of HPX-compatible impermeable plastic materials and
a mouthpiece for ease of inhalation; and
l the Polarean 2881 Polarisation Measurement Station, which provides a calibrated
measurement of the polarisation of hyperpolarised gas within the dose delivery inhalation bag.
The Group currently designs and builds the polariser equipment at a contract manufacturer and
has relationships with GMP gas producers to supply the Group with high purity 129Xe according to
the Group’s specifications.
In order to take advantage of the Group’s current products, an MRI machine is required to be
outfitted with hardware and software capable of operating at 129Xe frequency to detect the
HPX signal. In addition, the patient will need to wear a 129Xe RF chest coil to allow for detecting the
HPX MR signal in the lungs. Approximately 35,000 MRI machines are currently in use worldwide
and technically many of these can be easily adapted to be used with 129Xe frequency. The Group’s
products can be placed near the MRI scanner for ease of radiology workflow and, following the
m2m merger, the Group has continued to explore ways to further integrate the Group’s existing
technology with the coils which had previously been the focus of m2m.
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Strategic Report (continued)
4.3 Location
The Group is based at the Meridian Corporate Center, located in the Research Triangle Park area
of North Carolina, which provides a favourable location at which to further develop the core
technology and product range. The Group’s facilities consist of more than 6,900 square feet of
combined offices, laboratory space, inventory warehouse and assembly and testing areas. The
Group benefits from facilities that were originally purpose-built by GE for the design and manufacture
of hyperpolarisation equipment and components, pursuant to FDA-mandated guidelines.
Within these facilities are a dedicated research and development laboratory equipped with 3-phase
power, central compressed air, specialty gas handling and distribution and separate heating, ventilation
and air conditioning. The laboratory area also includes optical cell production equipment capable of
simultaneous processing of four optical cells for Xenon applications. The laboratory is designed for
safe operation of class 4 lasers and is equipped with laser power and spectral testing apparatus.
The Group also maintains a dedicated polariser test bed that is used for product development and
a dedicated Nuclear Magnetic Resonance (“NMR”) system capable of delivering available
electromagnetic field strength, utilised for calibrating absolute polarisation measurements of
hyperpolarised gas samples.
4.4 The Regulatory Environment
Prior to the receipt of any approvals for clinical use, the Group sold its polarisers and disposables
for research use only to academic medical centres with their research being subject to oversight by
their respective institutional review boards and conducted under IND from the FDA or equivalent
regulatory body.
On 28 December 2022, the Company announced that the FDA had granted approval for its drug
device combination product, XENOVIEW. XENOVIEW, prepared from the Xenon Xe 129 Gas Blend,
is a hyperpolarised contrast agent indicated for use with MRI for evaluation of lung ventilation in
adults and pediatric patients aged 12 years and older.
4.5 The Group’s Customers
The Group’s existing customer base already comprises some of the world’s luminary medical
imaging research institutions. Indeed, there are numerous research institutions worldwide utilising
the Group’s system and products, including Cincinnati Children’s Hospital, the University of Virginia,
University of Wisconsin – Madison, Duke University, University of Kansas, the University of Iowa and
the University of Texas MD Anderson Cancer Center in the US, Robarts Research Institute and
Hospital for Sick Children (SickKids) in Canada, the University of Oxford and the University of
Nottingham in the UK and the Fraunhofer Institute for Toxicology and Experimental Medicine
in Germany.
4.6 The Group’s Suppliers
The Group has entered into Master Service Agreements with two CROs in relation to the Phase III
trial. Pharma Start LLC, doing business as Firma Clinical Research, managed the trials and oversaw
the recruitment of patients for the trial. In addition, Icon Clinical Research Limited assisted with the
medical imaging aspects of the trial.
The Group has a long-standing relationship with its strategic investor Nukem Isotopes GmbH
(“Nukem”), a leading global supplier of 129Xe, the isotope of xenon which is provided to the various
gas blenders that in turn supply gas to the Group. It has a supply agreement with Nukem for 129Xe.
In June 2020 the Group signed an agreement with Linde Gas North America LLC (“Linde”), in relation
to the supply of the Group’s drug product, a 129Xenon gas blend. This agreement contains provision
for the supply of bulk 129Xe to be manufactured into the Active Pharmaceutical Product (API), 129Xe,
and for the blending, packaging, and distribution of its drug product under GMP. On 28 December
2022, the Group signed an amended agreement with Linde, which modified some commercial terms
and limited the agreement to the blending packaging and distribution of it drug product under GMP.
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Strategic Report (continued)
The Group has an arrangement with the Blur Product Development (“Blur”) to build its polariser
systems in Blur’s GMP facilities.
4.7 Current Trading and Prospects
Trading of the Group since the Company’s IPO continues to be in line with the Directors’
expectations. The potential of the Group’s technology enables the Directors to view the future with
confidence as the Company focuses on commercialisation of XENOVIEW.
4.8 Growth Strategy
With the recent FDA approval, the Group is adopting a traditional market entry strategy of building
market awareness for its technology through key opinion leaders and a direct sales force to reach
the key decision makers within its initial target market of large academic medical centres.
In implementing this strategy, the Group benefits from approximately 1,000 journal articles on the
use of hyperpolarised gas MRI that are currently published in peer-reviewed journals. Over time, as
more research centres purchase the Group’s equipment and begin clinical studies, an increasing
number of peer reviewed scientific articles are likely to be published, further enhancing the Group’s
credibility and raising awareness of the Group’s technology. The Directors believe that the market
for polarisers will grow as the technology gains wider acceptance as a tool for studying lung disease
and for monitoring the effectiveness of therapeutics. The Group also intends to continue patenting
and in-licensing hyperpolarised gas technology IP to protect its current position.
The Group’s initial sales targets will be the radiology and pulmonary medicine departments of top
academic hospital organisations in the US, who are opinion leaders in the use of new diagnostic
technologies and their application in a clinical setting.
The Group is expanding its sales and marketing teams. Because of the specialty nature of the
Group’s products in the pulmonary specialist market, which is concentrated in approximately 1,000
medical centres, the Directors believe that a small specialty sales force can be deployed effectively
at reasonable cost.
The Group may also choose to partner with companies that offer complementary products.
Furthermore, the Directors believe that the Group’s products will benefit a number of clinical
applications. While the Group’s HPX MRI technology provides more specific information than
currently available from existing lung diagnostic procedures (especially spirometry), the Group will
focus its use on specific clinical conditions where the high accuracy of HPX MRI and greater cost
are justified. The Directors do not believe that HPX MRI will replace low-cost spirometry as a general
screening tool but believe that it should add value in more demanding clinical applications where
HPX MRI addresses unmet diagnostic needs. These applications could include, but are not limited
to, the following:
l the monitoring of COPD therapy, especially for the most severe cases;
l the management of cystic fibrosis;
l determining the optimal use of biologic therapy in chronic asthma;
l a more efficient diagnosis of dyspnoea and the chronic cough;
l providing guidance for radiation therapy planning of lung cancer treatment;
l providing guidance for interventional pulmonology procedures including ablation and the
placement of valves and stents;
l surgical procedure planning for lung transplant and volume reduction surgery;
l diagnosis of ILD and monitoring of ILD therapy;
l diagnosis of pulmonary vascular disease (PVD) including pulmonary arterial hypertension
(PAH) and monitoring of therapy; and
l diagnosis and monitoring of long COVID patients.
Polarean Imaging plc
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Group Annual Report and Financial Statements
for the year ended 31 December 2022
Strategic Report (continued)
The Directors have begun to develop relationships with a range of strategic partners and will
evaluate opportunities which will enable the Group to address its target markets globally, either
alone or in collaboration with a partner.
5. Intellectual Property (“IP”)
The Group’s technology has been developed in four areas: (i) hyperpolarising gas; (ii) assuring the quality
of the hyperpolarised gas; (iii) using the polarised gas in MRI applications; and (iv) developing and
producing specialised RF coils to improve signal-to-noise ratios (“SNR”). GE had put a comprehensive
patent policy in place to protect its technology from potential competitors. The Group is now the sole
owner of this IP portfolio, which is based on 10 patent families, and when combined with the 7 patents
that were previously owned by m2m, that were transferred to the Group following the m2m Merger, the
Group’s portfolio covers four broad types of patents:
l imaging methods – these cover the imaging of a subject, or patient, who has inhaled a
hyperpolarised noble gas and the functionality of the gas as a contrast agent. Newly licensed
technology from Duke University extends the protection over these patents through to the early
2030s;
l hyperpolarisation methods – these are polarimetry patents covering the methods by which noble
gases are polarised and the methods by which the resulting polarised gas is isolated and delivered
to patients. The latest of these patents expire in the early 2020s;
l hyperpolarisation equipment – these patents cover the multiple preferred mechanical design and
automation elements of hyperpolarised equipment; and
l RF coil patents – these patents cover the use of cryogenics to improve RF coils SNR and image
quality and may play an important part in the next generation of applications such as neurological,
cardiac and oncology imaging.
Polarean is committed to proactively developing further IP, both internally and through licensing
arrangements with third parties, as part of the Group’s overall growth strategy. The third parties are likely
to include the Group’s key collaborative academic sites, such as Duke University, that are seeking to
develop emerging applications and technologies. Because of the Group’s extensive patent portfolio and
leading market position, the Directors believe the Group is an attractive licensing partner for academic
research institutions that are interested in out-licensing such IP. One such patent application
(US15/120013), which is currently pending, relates to improving the overall efficiency of the
hyperpolarisation process. This patent has also been exclusively licensed to the Group by Duke University.
The Directors believe that this patent, now having been prosecuted successfully to issuance in a number
of geographic jurisdictions worldwide, would enable the Group to protect methods for increasing the level
of hyperpolarisation significantly, which could improve the competitive economics of the Group’s products.
6. Principal Risks and Uncertainties
The principal risks and uncertainties facing the Group are detailed below:
Early stage of operations
The Group’s operations are at an early stage of development and there can be no guarantee that the
Group will be able to, or that it will be commercially advantageous for the Group to, develop its proprietary
technology. Further, the Group currently has no positive operating cash flow and its ultimate success will
depend on the Directors’ ability to implement the Group’s strategy, generate cash flow and access capital
markets.
Principal mitigation
The Group has successfully advanced the 129Xe technology for several years, including selling polarisers
for the research market. The Group has been able to access capital required to continue to advance the
technology.
Polarean Imaging plc
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Group Annual Report and Financial Statements
for the year ended 31 December 2022
Strategic Report (continued)
Regulatory approvals and compliance
The Group will need to obtain various regulatory approvals (including FDA and European Medicines
Agency (“EMA”) approvals) and otherwise comply with extensive regulations regarding safety, quality and
efficacy standards in order to market its future products. These regulations, including the time required
for regulatory review, vary from country to country and can be lengthy, expensive and uncertain.
Principal mitigation
The Group utilises external specialists in regulatory affairs who consult with other experts to ensure that
internal control processes and clinical trial designs meet current regulatory requirements. The Group
also engages directly with regulatory authorities when appropriate.
Future funding requirements
The Group will need to raise additional funding or enter into a strategic partnership with industry partners
to undertake work beyond that being funded by the £27 million (before expenses) 2021 fundraising. There
is no certainty that this will be possible at all or on acceptable terms.
Principal mitigation
The Group successfully engaged with investors to generate significant cash resources to date, including
the 2021 financing that raised £27 million, before expenses. The Group’s management team expects that
continued access to capital markets, or other access to capital, will be required to support the Group through
regulatory approval and initial commercialisation efforts in the US. See Going Concern discussion below.
Dependence on key personnel
The success of the Group, in common with other businesses of a similar size, will be highly dependent
on the expertise and experience of the Directors and key employees. However, the retention of such key
personnel cannot be guaranteed. Should key personnel leave the Group’s business, prospects, financial
condition or results of operations may be materially adversely affected.
Principal mitigation
The Group’s recruitment processes are designed to identify and attract the best candidates for specific
roles. The Group aims to provide competitive rewards and incentives to staff and directors.
Intellectual property and proprietary technology
No assurance can be given that any current or future patent applications will result in granted patents,
that the scope of any patent protection will exclude competitors or provide competitive advantages to
the Group, that any of the Group’s patents will be held valid if challenged or that third parties will not
claim rights in or ownership of the patents and other proprietary rights held by the Group.
Principal mitigation
The Group has a long-standing track record of IP generation and successful applications and has a
long-standing relationship with our patent attorney who has a deep understanding of our technology. The
Group actively manages its IP, engaging with specialists to apply for and defend IP rights in appropriate
territories.
Technology and products
The Group is a developer and service provider for noble gas 129Xe devices and ancillary instruments with
a special focus on pulmonary imaging. The development and commercialisation of its proprietary
technology and future products, which are in early stages of development, will require multiple series of
clinical trials and there is a risk that safety and efficacy issues may arise when the products are tested.
There is also a risk that there will be delays to the development of the products or that unforeseen
technical problems arise as the Group’s technology becomes increasingly automated. These risks are
common to all new medical products and there is also a risk that the clinical trials may not be successful.
Polarean Imaging plc
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Group Annual Report and Financial Statements
for the year ended 31 December 2022
Strategic Report (continued)
Principal mitigation
The Group has a depth of knowledge and experience in the area of medical devices development for
the high-resolution medical imaging market. The Group also utilises external experts to supplement their
knowledge in critical areas such as safety, manufacturing and software development.
Research and development risk
The Group will be operating in the life sciences and medical device development sector and will look to
exploit opportunities within that sector. The Group will therefore be involved in complex scientific research
and industry experience indicates that there may be a very high incidence of delay or failure to produce
results. The Group may not be able to develop new products or to identify specific market needs that can
be addressed by technology solutions developed by the Group.
Principal mitigation
The Group has a depth of knowledge and experience in the area of medical devices development for
the high-resolution medical imaging market. The Group also utilises external experts to supplement their
knowledge in critical areas such as conducting clinical trials and regulatory affairs.
Competition
The Group notes that several start-ups operating in the CT software space have begun efforts to
commercialise products which represent to characterise lung ventilation. These technologies use ionising
radiation, whereas the Group’s technology does not. In addition, these technologies are unable to further
assess gas exchange, red blood cell transport, nor microvascular haemodynamics.
Principal mitigation
The Group believes that these emerging technologies validate the unmet need for the use of imaging in
assessing pulmonary function. However, their use of ionising radiation, combined with their inability to
assess comprehensive pulmonary function will render their utility limited and the Directors see no effect
on the current market expectations of Polarean.
Reliance on third parties
The business model for the Group anticipates that it will have limited internal resources over the next
few years and that it will use third party providers wherever possible to conduct the research,
development, registration, manufacture, marketing and sales of its proposed products. The commercial
success of the Group’s products will depend upon the performance of these third parties.
Principal mitigation
The Group seeks experts in the areas where it utilises outsourcing. Wherever possible, the Group seeks
to have duplicate suppliers to lessen the reliance on a particular vendor.
Manufacturing
There can be no assurance that the Group’s proposed products will be capable of being manufactured
in commercial quantities, in compliance with regulatory requirements and at an acceptable cost.
The Group outsources the manufacture of the raw materials and finished products required in connection
with the research, development and commercial manufacture of its proposed products and, as such,
is wholly dependent upon third parties for the provision of adequate facilities and raw material supplies.
129Xe, the specific isotope of xenon which is the active ingredient in the Group’s drug-device product, is
available from a limited number of suppliers and there can be no assurance that adequate supplies of
this material at acceptable cost can be obtained. In addition, where the Group is dependent upon third
parties for manufacture, its ability to procure the manufacture of the drug-device in a manner which
complies with regulatory requirements may be constrained, and its ability to develop and deliver such
products on a timely and competitive basis may be adversely affected.
Polarean Imaging plc
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Group Annual Report and Financial Statements
for the year ended 31 December 2022
Strategic Report (continued)
Principal mitigation
The Group has designed the manufacturing process to be scalable and has internal experts who train
the outside vendors. The Group has established relationships with two 129Xe suppliers to mitigate the risk
that 129Xe supply will be a limitation to the development and commercialisation of its products. In addition,
the Group has established a relationship with a GMP outside polariser manufacturer.
Product development timelines
Product development timelines are at risk of delay, particularly since it is not always possible to predict
what the FDA will require for approval of future NDA’s. There is a risk therefore that product development
could take longer than presently expected by the Directors. If such delays occur the Group may require
further working capital. The Directors shall seek to minimise the risk of delays by careful management
of projects.
Principal mitigation
The Group utilises consultants who are experts in preparing and filing future NDAs in the US.
General legal and regulatory issues
The Group’s operations are subject to laws, regulatory restrictions and certain governmental directives,
recommendations and guidelines relating to, amongst other things, occupational safety, laboratory
practice, the use and handling of hazardous materials, prevention of illness and injury, environmental
protection and animal and human testing. There can be no assurance that future legislation will not
impose further government regulation, which may adversely affect the business or financial condition of
the Group.
Principal mitigation
The Group consults experts for advice in areas such as occupational safety, laboratory practice and
human testing.
Healthcare pricing environment
In common with other healthcare products companies, the ability of the Group and any of its licensees
or collaborators to market its products successfully depends in part on the extent to which reimbursement
for the cost of such products and related treatment will be available from government health
administration authorities, private health coverage insurers and other organisations.
Principal mitigation
The Group is consulting with several experts in the field of reimbursement for healthcare products in the
US to determine the best strategy for accessing adequate reimbursement for its products.
7. Section 172 statement
As required by section 172 of the Companies Act 2006 (the “Act”), a director of a company must act in
the way he or she considers, in good faith, would likely promote the success of the company for the
benefit of the shareholders. In doing so, the director must have regard, amongst other matters, to the
following issues:
l the likely consequences of any decisions in the long term;
l the interests of the company’s employees;
l the need to foster the company’s business relationships with suppliers/customers and others;
l the impact of the company’s operations on the community and environment;
l the company’s reputation for high standards of business conduct; and
l the need to act fairly between members of the company.
Polarean Imaging plc
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Group Annual Report and Financial Statements
for the year ended 31 December 2022
Strategic Report (continued)
The information required by section 172 of the Act is included in the Strategic Report on page 16,
the Directors Report on pages 18 to 22 and the Corporate Governance Statement on pages 23 to 29.
Kenneth West
Non-Executive Chairman
25 May 2023
Polarean Imaging plc
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Group Annual Report and Financial Statements
for the year ended 31 December 2022
Directors’ Report
The Directors present their report on the affairs of Polarean Imaging plc (the “Company”) and its
subsidiary, referred to as the Group, together with the audited Financial Statements and Independent
Auditors’ Report for the year ended 31 December 2022.
Principal activities
The main activity of the Group is a drug-device manufacturer and service provider for noble gas polariser
devices, its proprietary 129Xe drug and ancillary instruments with a special focus on pulmonary imaging.
Results and dividends
During the year ended 31 December 2022 the Group recorded a loss after tax of US$13,905,596
(2021: US$14,016,004) and a net cash outflow from operating activities of US$12,258,031
(2021: US$12,250,467).
The Directors do not recommend the payment of a dividend (2021: US$Nil).
Going concern
In considering the appropriateness of this basis of preparation, the Directors have reviewed the Group’s
working capital forecasts for a minimum of 12 months from the date of the approval of this financial
information. Based on their consideration, the Directors have a reasonable expectation that the Group
has adequate resources to continue for the foreseeable future and that carrying values of intangible
assets are supported. Thus, they continue to adopt the going concern basis of accounting in preparing
this financial information.
In considering the appropriateness of this basis of preparation, the Directors have reviewed the Group’s
working capital forecasts for a minimum of 12 months from the date of the approval of this financial
information. It is anticipated that additional capital will need to be raised by the end of the second quarter
of 2024 in order to continue to fund the Group’s activities at their planned levels beyond this date. This
represents a material uncertainty that may cast significant doubt about the Group’s and Company’s ability
to continue as a going concern. However, the Directors have a reasonable expectation that this uncertainty
can be managed to a successful outcome, and based on that assessment, the Group has adequate
resources to continue for the foreseeable future. Thus, they continue to adopt the going concern basis of
accounting in preparing these financial statements.
Future developments
The Company’s future developments are outlined in the Strategic Report on page 7.
Research design & development
Research and development (“R&D”) is performed by employees of the company and through
collaborative efforts with academic researchers. The Group is committed to increasing its R&D budget
to meet anticipated market demands for additional technology. In addition, the company also in-licenses
technology from collaborative academic institutions. Details of R&D carried out during the year are
contained in the Strategic Report.
Financial risk management
Financial risk management policies and objectives for capital management are outlined in the principal
risks and uncertainties section of the Strategic Report on pages 13 to 16 and in note 26 to the financial
statements.
Polarean Imaging plc
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Group Annual Report and Financial Statements
for the year ended 31 December 2022
Directors’ Report (continued)
Directors’ indemnities
The Group has made qualifying third-party indemnity provisions for the benefit of its Directors, which
were made during the year and remain in force at the date of this report.
Events after the reporting period
Details of significant events since the reporting period are contained in note 29 of the financial
statements.
Directors Resigned/Appointed
Kenneth West Non-Executive Chairman –
Richard Hullihen Chief Executive Officer –
Charles Osborne Chief Financial Officer –
Bastiaan Driehuys, PH.D. Chief Technology Officer –
Jonathan Allis, PH.D. Non-Executive Director Resigned 4 May 2022
Daniel Brague Non-Executive Director Appointed 4 May 2022
Jurgen Laucht Non-Executive Director –
Cyrille Petit Non-Executive Director –
Frank Schulkes Non-Executive Director Appointed 13 April 2022
Marcella Ruddy, M.D. Non-Executive Director Appointed 25 August 2022
Frank Schulkes was also appointed as Chair of the Audit Committee on 13 April 2022.
Daniel Brague was also appointed as Chair of the Remuneration Committee on 4 May 2022.
Directors’ emoluments
2022
Executive Directors
Bastiaan Driehuys
Richard Hullihen
Charles Osborne
Non-Executive Directors
Jonathan Allis (Note A)
Juergen Laucht
Cyrille Petit
Kenneth West
Daniel Brague (Note A)
Frank Schulkes (Note A)
Marcella Ruddy (Note A)
Total
Salary, Fees
& Bonus
US$
Benefits
US$
Share-Based
Payments
US$
Total
US$
36,500
367,603
331,010
–
15,206
11,103
69,512
201,235
102,024
106,012
584,044
444,137
24,086
41,500
36,500
56,753
23,941
26,158
11,093
––––––––––––
955,144
––––––––––––
––––––––––––
–
–
–
–
–
–
–
––––––––––––
26,309
––––––––––––
––––––––––––
98,313
69,512
96,002
74,318
79,514
103,143
49,934
––––––––––––
943,507
––––––––––––
––––––––––––
122,399
111,012
132,502
131,071
103,455
129,301
61,027
––––––––––––
1,924,960
––––––––––––
––––––––––––
Note A: Jonathan Allis resigned as Non-Executive Chairman and Chair of the Remuneration Committee
on 4 May 2022. Daniel Brague was appointed Non-Executive Director on 4 May 2022. Frank Schulkes
was appointed Non-Executive Director on 13 April 2022. Marcella Ruddy was appointed Non-Executive
Director on 25 August 2022.
Polarean Imaging plc
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Group Annual Report and Financial Statements
for the year ended 31 December 2022
Directors’ Report (continued)
2021
Executive Directors
Bastiaan Driehuys
Richard Hullihen
Charles Osborne
Non-Executive Directors
Jonathan Allis
Juergen Laucht
Cyrille Petit
Kenneth West
Total
Salary, Fees
& Bonus
US$
Benefits
US$
Share-Based
Payments
US$
Total
US$
43,250
334,248
301,007
–
14,270
14,408
69,406
209,488
100,512
112,656
558,006
415,927
85,000
48,250
43,250
38,250
––––––––––––
893,255
––––––––––––
––––––––––––
–
–
–
–
––––––––––––
28,678
––––––––––––
––––––––––––
94,943
69,406
85,122
89,835
––––––––––––
718,712
––––––––––––
––––––––––––
179,943
117,656
128,372
128,085
––––––––––––
1,640,645
––––––––––––
––––––––––––
Directors’ interests
The Directors who held office at 31 December 2022 had the following direct interest in the ordinary
shares of the Company at 31 December 2022.
Directors’ beneficial interests in shares of the Company:
Richard Hullihen
Kenneth West
Bastiaan Driehuys
Cyrille Petit
2022
Number
3,201,959
475,594
12,267,503
584,000
2022
%
2021
Number
3,201,959
1.5
475,594
0.2
5.9 12,267,503
584,000
0.3
2021
%
1.5
0.2
5.9
0.3
The shareholdings noted above include those shares held by connected persons of the individual director.
Directors’ beneficial interests in options to subscribe for additional shares of the Company:
Richard Hullihen
Kenneth West
Bastiaan Driehuys
Juergen Laucht
Cyrille Petit
Charles Osborne
Frank Schulkes
Daniel Brague
Marcella Ruddy
2022
Number
3,135,440
2,263,218
1,686,000
884,400
500,000
1,700,000
500,000
500,000
500,000
2021
Number
3,135,440
2,263,218
1,686,000
884,400
500,000
1,700,000
–
–
–
Directors’ beneficial interests in warrants to subscribe for additional shares of the Company:
Bastiaan Driehuys
Kenneth West
2022
Number
2021
Number
148,456
2,801,084
148,456
2,801,084
Polarean Imaging plc
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Group Annual Report and Financial Statements
for the year ended 31 December 2022
Directors’ Report (continued)
The warrants issued to Bastiaan Driehuys have an exercise price of US$0.00037. The warrants issued
to Kenneth West have an exercise price of between US$0.0041 and US$0.0075. The warrant holdings
noted above include those warrants held by connected persons of the individual director.
The options and warrants holdings noted above include those shares held by connected persons of the
individual director.
Share option schemes
In order to provide incentive for the management and key employees of the Group, the Company awards
share options. The Directors defined a new plan in 2018 and implemented it. The existing options granted
prior to the merger were converted to options in Polarean Imaging plc.
The Company are, subject to Shareholder approval at the AGM, proposing to amend and restate the
Polarean Imaging plc Share Option Plan (the “Plan”), which was established as of 29 March 2018, to:
(i) increase the number of ordinary shares that may be allocated under the Plan from 5% to 10% of the
ordinary share capital in issue immediately prior to any grant; and (ii) include relevant provisions to permit
the granting of incentive stock options to U.S. employees. If approved by Shareholders, the requested
increase in shares that may be allocated under the Plan would result in a total of approximately 20 million
shares that may be allocated under the Plan as of 28 June 2023; which includes approximately 10 million
ordinary shares currently allocated and approximately 10 million ordinary shares reserved for future
issuances. The Company also wishes to permit the granting of incentive stock options to U.S. employees,
which if certain requirements are met, can provide tax advantages to the employee over non-statutory
stock options.
Substantial Shareholders
As well as the Directors’ interests reported above, the following interests of 3.0% and above as at
28 February 2023 were as follows:
Name
Ordinary Shares
Amati AIM VCT plc
Hargreaves Lansdown
Bracco Imaging S.p.A.
Bastiaan Driehuys
NUKEM Isotopes GmbH
Tyndall Investment Management
Chelverton UK Equity Growth Fund
Canaccord Genuity Wealth Management (Inst)
24,132,258
16,808,283
16,388,888
12,267,503
11,523,462
9,086,068
8,500,000
7,111,877
% held
11.33%
7.89%
7.69%
5.76%
5.41%
4.26%
3.99%
3.34%
Corporate Responsibility
The Board recognises its employment, environmental and health and safety responsibilities. It devotes
appropriate resources towards monitoring and improving compliance with existing standards. The
Executive Directors are responsible for these areas at Board level, ensuring that the Group’s policies are
upheld and providing the necessary resources.
Employees
The Group is committed to achieving equal opportunities and to complying with relevant
anti-discrimination legislation. It is established Group policy to offer employees and job applicants the
opportunity to benefit from fair employment, without regard to their sex, sexual orientation, marital status,
race, religion or belief, age or disability. Employees are encouraged to train and develop their careers.
Polarean Imaging plc
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Group Annual Report and Financial Statements
for the year ended 31 December 2022
Directors’ Report (continued)
The Group has continued its policy of informing all employees of matters of concern to them as
employees, both in their immediate work situation and in the wider context of the Group’s well-being.
Communication with employees is affected through the Board, the Group’s management briefing’s
structure, formal and informal meetings and through the Group’s information systems.
The Directors are responsible for preparing the Strategic Report, the Directors’ Report and the Financial
Statements in accordance with applicable law and regulations.
The Act requires the directors to prepare financial statements for each financial year. Under that law the
directors have elected to prepare the financial statements in accordance with UK-adopted International
Accounting Standards (IFRS) and applicable law.
In accordance with the Act, 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 Company and the Group and of
the profit or loss of the Group for that period. In preparing these financial statements, the Directors are
required to:
l select suitable accounting policies and then apply them consistently;
l make judgements and accounting estimates that are reasonable and prudent;
l state whether applicable accounting standards have been followed, subject to any material
departures disclosed and explained in the financial statements; and
l prepare the financial statements on the going concern basis unless it is inappropriate to presume
that the Group will continue in business.
The Directors are responsible for keeping adequate accounting records that are sufficient to show and
explain the Company’s transactions and disclose with reasonable accuracy at any time the financial
position of the Group and enable them to ensure that the financial statements comply with the Act. They
are also responsible for safeguarding the assets of the Group and hence for taking reasonable steps for
the prevention and detection of fraud and other irregularities.
They are further responsible for ensuring that the Strategic Report and the Directors’ Report and other
information included in the Annual Report and Financial Statements is prepared in accordance with
applicable law in the United Kingdom.
The maintenance and integrity of the Polarean Imaging plc website is the responsibility of the Directors.
Legislation in the United Kingdom governing the preparation and dissemination of the accounts and the
other information included in annual reports may differ from legislation in other jurisdictions.
Auditors
Each of the persons who are Directors at the time when this Directors’ Report is approved has
confirmed that:
l so far as that Director is aware, there is no relevant audit information of which the Group and the
Group’s auditor is unaware; and
l that Director has taken all the steps that ought to have been taken as a director in order to be aware
of any relevant audit information and to establish that the Company and the Group’s auditor is
aware of that information.
Crowe U.K. LLP has expressed its willingness to continue in office and a resolution to re-appoint the firm
as Auditor and authorising the Directors to set their remuneration will be proposed at the forthcoming
Annual General Meeting.
Kenneth West
Non-Executive Chairman
25 May 2023
Polarean Imaging plc
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Group Annual Report and Financial Statements
for the year ended 31 December 2022
Corporate Governance Statement
As Chairman of the Board of Directors of Polarean Imaging Plc (“Polarean”, or the “Company/Group” as
the context requires), it is my responsibility to ensure that Polarean has both sound corporate governance
and an effective board of directors (“Board”). As Chairman of the Company, my responsibilities include
leading the Board effectively, overseeing the Company’s corporate governance model, communicating
with shareholders, and ensuring that good information flows freely between the Executive and
Non-Executive Directors in a timely manner. My leadership of the Board is undertaken in a manner which
ensures that the Board retains integrity and effectiveness and includes creating the right Board dynamic
and ensuring that all important matters, in particular strategic decisions, receive adequate time and
attention at Board meetings.
It is the Board’s job to ensure that Polarean is managed for the long-term benefit of all shareholders,
with effective and efficient decision-making. Corporate governance is an important part of that role,
reducing risk and adding value to our business.
The Directors of Polarean recognise the value of good corporate governance in every part of its
business. As Polarean is an AIM-listed company, it is required to adopt a recognised corporate governance
code and disclose how it complies with that code and, to the extent Polarean departs from the corporate
governance provisions outlined by that code, it must explain its reasons for doing so. The Directors have
adopted the requirements of the Quoted Companies Alliance's Corporate Governance Code (the "QCA
Code"), to the extent that they consider it appropriate having regard to the Company's size, board
structure, stage of development and resources.
The Board considers that compliance with the QCA Code will enable us to serve the interests of all our
key stakeholders, including our shareholders, and will promote the maintenance and creation of long-term
value in the Company. This report describes our approach to governance, including information on
relevant policies, practices and the operation of the Board and its Committees. Additional detail on how
the company has applied the QCA code is also provided in the corporate governance section of our
website http://www.polarean-ir.com/content/investors/governance.asp. Any areas of non-compliance with
the QCA Code are also explained.
Polarean seeks to constantly improve its corporate governance practices. Prior to the Company listing in
March 2018, the Company implemented certain governance related measures including the formation
of the Company’s Audit and Remuneration Committees, and the adoption of a Share Dealing Code.
Key governance changes that occurred in the year included the appointments of Frank Schulkes, Daniel
Brague and Marcella Ruddy, M.D. as Non-Executive Directors. Mr. Schulkes was appointed as Chair of
the Audit Committee and Mr. Brague was appointed Chair of the Remuneration Committee. Jonathan
Allis retired as Chairman of the Company and was replaced by Kenneth West, an existing Non-Executive
Director of the Company, in May 2022.
Strategy, Risk Management and Responsibility
A description of the Company’s business model and strategy can be found on pages 7 to 13 in the
Strategic Report, and the key challenges in their execution can be found on pages 13 to 16 under
“Principal Risks and Uncertainties”.
The Board is responsible for the monitoring of financial performance against budget and forecast and
the formulation of the Group’s risk appetite including the identification, assessment and monitoring of
Polarean’s principal risks. The Board recognises the need for an effective and well-defined risk
management process and it oversees and regularly reviews the current risk management and internal
control mechanisms.
Polarean Imaging plc
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Group Annual Report and Financial Statements
for the year ended 31 December 2022
Corporate Governance Statement (continued)
The Board has overall responsibility for identifying, monitoring and reviewing the Company’s risks, and
assessing the systems of external control for effectiveness. The Executive Directors report any new or
changed risks, and any changes in risk management or control to the Board. The Board discusses all
business matters having regard to the risks for the Group and to the extent that risks inherent in a
particular activity are considered significant, appropriate action is taken and steps taken to mitigate the
issue. The overall objective of the Board is to set policies that seek to reduce risk as far as possible
without unduly affecting the Company’s competitiveness and flexibility.
The Board is satisfied that the procedures in place meet the particular needs of the Group in managing
the risks to which it is exposed. The Board is satisfied with the effectiveness of the system of internal
controls, but by their very nature, these procedures can provide reasonable, not absolute, assurance against
material misstatement or loss. During the review period, the Board delegated responsibility to the Audit
Committee for ensuring that the Company’s management reviews, monitors and reports on the integrity of
the consolidated financial statements of the Company and related financial information. During the review
period, the Audit Committee was comprised of Frank Schulkes, Juergen Laucht and Cyrille Petit.
It meets as required and specifically to review the Interim Report and Annual Report, and to consider
the suitability and monitor the effectiveness of internal control processes.
The Audit Committee reviews the findings of the external auditor and reviews accounting policies and
material accounting judgements. The independence and effectiveness of the external auditor is reviewed
annually. The possibility of undertaking an audit tender process is considered on a regular basis. In
addition, the Audit Committee meets at least once year with the auditor to discuss their independence
and objectivity, the Annual Report, any audit issues arising, internal control processes, appointment and
fee levels and any other appropriate matters. Based on the above, there will be no Audit Committee
Report outlined in this Annual Report. The Company has strict segregation of duties and authority controls
which are reviewed annually by the auditors.
The Board currently takes the view that an internal audit function is not considered necessary or practical
due to the size of the Group, its business and assets, and the close day-to-day control exercised by the
executive directors. The Board is satisfied that the systems and procedures currently employed provide
sufficient assurance that a sound system of internal controls are in place, which safeguards the
shareholders’ investment and the Group’s assets. However, the Board will continue to monitor the need
for an internal audit function.
The Board is responsible for the Group’s system of internal control and for reviewing its effectiveness.
Such a system is designed to manage rather than eliminate risk of failure to achieve the business
objectives and can only provide reasonable and not absolute assurance against material misstatement
or loss. The Company’s current system of internal financial control comprises those controls established
to provide reasonable assurance of:
l The safeguarding of assets against unauthorised use or disposal; and
l The maintenance of proper accounting records and the reliability of financial information used within
the business and for publication.
The key procedures of internal financial control of the Group are as follows:
l The Board reviews and approves budgets and monitors performance against those budgets on a
monthly basis; and
l The Group has clearly defined reporting and authorisation on procedures relating to the key financial
areas.
The recent global COVID-19 pandemic has resulted in increased risks within the global economy. The
extent of the effect of the virus, including its long-term impact, remains uncertain and the Company
continues to monitor the situation.
Polarean Imaging plc
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Group Annual Report and Financial Statements
for the year ended 31 December 2022
Corporate Governance Statement (continued)
The Board
The Board is comprised of Kenneth West (Non-Executive Chairman), Richard Hullihen (CEO), Charles
Osborne (CFO) Bastiaan Driehuys (CTO), Juergen Laucht (NED), Cyrille Petit (NED), Frank Schulkes
(NED). Daniel Brague (NED) and Marcella Ruddy, M.D. (NED). The Board is supported by the Company
Secretary, Stephen Austin. The biographical details of the Directors of the Company are set out on the
Company’s website: http://www.polarean-ir.com/content/investors/board.asp.
The Board meets regularly and is responsible for the Group’s corporate strategy, monitoring financial
performance, approval of capital expenditure, treasury and risk management policies. Board papers are
sent out to all Directors in advance of each Board meeting including management accounts and
accompanying reports from those responsible.
The Directors believe that the Board, as a whole, has a broad range of commercial and professional
skills, enabling it to discharge its duties and responsibilities effectively and that the Non-Executive
Directors, together, have a sufficient range of experience and skills to enable them to provide the
necessary guidance, oversight and advice for the Board to operate effectively. All Directors are
encouraged to use their independent judgement and to challenge all matters, whether strategic or
operational.
Frank Schulkes, Daniel Brague and Marcella Ruddy, M.D. are the Company’s three independent
Non-Executive Directors. The guidance in the QCA Code is for a company to have at least two
independent Non-Executive Directors.
The Board will seek to take into account any Board imbalances for future nominations. The Company is
committed to a culture of equal opportunities for all employees regardless of gender. The Board aims to
be diverse in terms of its range of culture, nationality and international experience.
Given the current phase of Polarean’s life cycle, the Board has determined that it is not practicable to set
measurable objectives for achieving gender diversity. It is the Board’s intention as the size and complexity
of the Company grows, to set and aim to achieve gender diversity objectives pursuant to a defined
diversity policy.
All of the Executive Directors work full time for the Company. The Chairman is expected to devote the
necessary amount of time to comprehensively fulfil the duties of the role, and in any case not less than
52 days per annum, and the Non-Executive Directors are each expected to dedicate not less than 15 days
per annum to the Company’s affairs. The time commitment required by the Group is an overriding principle
that each Director will devote as much time as is required to carry out the roles and responsibilities that
the Director has agreed to take on.
The Non-Executive Directors receive a fee for their services as a director which is approved by the Board,
being mindful of the time commitment and responsibilities of their roles and of current market rates for
comparable organisations and appointments. In addition, Non-Executive Directors are also reimbursed
for travelling and other incidental expenses incurred on Group business.
Executive and Non-Executive Directors are subject to re-election intervals as prescribed in the Company’s
articles of association. At each Annual General Meeting one-third of the Directors, who are subject to
retirement by rotation shall retire from office. They can then offer themselves for re-election. The letters
of appointment of all Non-Executive Directors are available for inspection at the Company’s registered
office during normal business hours. The Executive Directors are employed under service contracts
requiring six months’ notice by either party. Non-Executive Directors and the Chairman receive payments
under appointment letters which are terminable by three months’ notice by either party.
Polarean Imaging plc
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Group Annual Report and Financial Statements
for the year ended 31 December 2022
Corporate Governance Statement (continued)
There were seven scheduled board meetings held during 2022. The table below sets out attendance statistics
for each Director at Board and, where relevant, Committee meetings held during the financial year.
Audit
Board Committee
(7 meetings held) (4 meetings held)
Director
Remuneration
Committee
(1 meeting held)
Richard Hullihen 7/7
Kenneth West 7/7
Bastiaan Driehuys 7/7
Jonathan Allis (Note A) 0/2
Juergen Laucht 6/7 4/4
Cyrille Petit 7/7 4/4
Charles Osborne 7/7
Frank Schulkes (Note A) 5/5 3/3
Daniel Brague (Note A) 5/5
Marcella Ruddy (Note A) 2/2
1/1
1/1
1/1
Note A: Directors were on the Board for a portion of 2022. The denominator in each fraction represents
the numbers of meetings held while they were Directors.
The Board, as a whole, is responsible for the overall management of the Group and for its strategic
direction, including approval of the Group’s strategy, its annual business plans and budgets, the interim
and full year financial statements and reports, any dividend proposals, the accounting policies, major
capital projects, any investments or disposals, its succession plans and the monitoring of financial
performance against budget and forecast and the formulation of the Group’s risk appetite including the
identification, assessment and monitoring of the Group’s principal risks. In accordance with best practice,
Polarean has adopted a formal schedule of Matters Reserved for the Board. These are reviewed annually,
and any items not included within the schedule are delegated to the management team.
In order to discharge their duties effectively, the Board uses third parties to advise the Directors of their
responsibilities including receiving advice from the Company’s external lawyers. The Board reviews the
appropriateness and opportunity for continuing professional development in order to keep each Director’s
skillset up-to-date. In addition to their general Board responsibilities, Non-Executive Directors are
encouraged to be involved in specific workshops or meetings, in line with their individual areas of
expertise. The Board shall review annually the appropriateness and opportunity for continuing
professional development, whether formal or informal. All Directors have received AIM Rules and Directors
Responsibilities training provided by the nominated advisor and are encouraged to undertake any ongoing
training they feel they require to assist with the commission of their role on the Board.
Polarean’s Company Secretary, Stephen Austin, is responsible for ensuring that Board procedures are
followed and that the Company complies with all applicable rules, regulations and obligations governing
its operation, as well as helping the Chairman maintain excellent standards of corporate governance.
There are processes in place enabling Directors to take independent advice at the Company’s expense
in the furtherance of their duties, and to have access to the advice and services of the Company
Secretary.
Board Committees
Certain Board responsibilities are delegated to committees who fulfil these functions in line with the terms
of references established by the Board.
Polarean Imaging plc
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Group Annual Report and Financial Statements
for the year ended 31 December 2022
Corporate Governance Statement (continued)
Audit Committee
The Audit Committee comprised Frank Schulkes (Chair), Juergen Laucht and Cyrille Petit. The Audit
Committee’s responsibilities during the review period included ensuring that the financial performance,
position and prospects for the Group were properly monitored, controlled and reported and specifically to
review the Interim Report and Annual Report, and to consider the suitability and monitor the effectiveness
of internal control processes. The Committee held 4 meetings during the year.
As outlined above, during the review period, Frank Schulkes was appointed as the Chairman of the Audit
Committee following his appointment to the Board. Following Mr Schulkes’ appointment, the Board now
considers the Company to have a fully constituted Audit Committee.
Remuneration Committee
The remuneration committee comprised Daniel Brague (Chair), Bastiaan Driehuys and Juergen Laucht.
The purpose of the Remuneration Committee is to ensure that the Executive Directors and other
employees are fairly rewarded for their individual contribution to the overall performance of the Group.
The Committee considers and recommends to the Board the remuneration of the Executive Directors and
is kept informed of the remuneration packages of senior staff and invited to comment on these. There
was one meeting during 2022. The Board retains responsibility for overall remuneration policy. Executive
remuneration packages are designed to attract and retain executives of the necessary skill and calibre to
run the Group. The Remuneration Committee recommends to the Board the remuneration packages by
reference to individual performance and uses the knowledge and experience of the Committee members,
published surveys relating to AIM companies, the medical imaging and contrast agents’ industries and
market changes generally. The Remuneration Committee has responsibility for recommending any
long-term incentive schemes. No Director is responsible for setting their own remuneration. A report by
the Chairman of the Remuneration Committee is included on pages 30 and 31.
As outlined above, during the review period, Daniel Brague was appointed as the Chairman of the
Remuneration Committee following his appointment to the Board.
Nomination Committee
The Company does not currently have a Nomination Committee, as the Board does not consider it
appropriate to establish such a committee at this stage of the Company’s development. Decisions which
would usually be taken by the nomination committee, such as appointments to the Board, will be taken
by the Board as a whole. The Board will monitor on an ongoing basis the need for a formal Nominations
Committee. The Chairman and the Board continue to monitor and evolve the Company’s corporate
governance structures and processes, and maintain that these will evolve over time, in line with the
Company’s growth and development.
Advisors
The Board has regular contact with its advisors to ensure that it is aware of changes to generally
accepted corporate governance procedures and requirements and that the Group remains, at all times,
compliant with applicable rules and regulations. The Company holds appropriate insurance cover in
respect of possible legal action against its Directors. The Company’s nominated advisor supports the
Board’s development, specifically providing guidance on corporate governance and other regulatory
matters, as required. All Directors may receive independent professional advice at the Group’s expense,
if necessary, for the performance of their duties.
Board Performance Evaluation
Formal internal evaluation of the Board, its Committees and individual directors is seen as an important next
step in the development of the board. Going forward, this will be undertaken on annual basis in the form of
peer appraisal, questionnaires and discussions to determine the effectiveness and performance in various
areas as well as the directors’ continued independence. The criteria against which effectiveness is considered
will be aligned to the strategy of the Group and management forecasts and budgets that are already in place.
Polarean Imaging plc
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Group Annual Report and Financial Statements
for the year ended 31 December 2022
Corporate Governance Statement (continued)
The purpose of such an evaluation will be to ensure that its members collectively function in an efficient
manner, focusing more closely on defined objectives and targets for improving performance, as well as
reviewing the effectiveness of each Committee.
During frequent Board meetings/calls, the Directors discuss areas where they feel a change would be
beneficial for the Company, and the Company Secretary remains on hand to provide advice.
Culture
The Board recognises that their decisions regarding strategy and risk will impact the corporate culture
of the Group as a whole and that this will impact the performance of the Group. The Board is very aware
that the tone and culture set by the Board will greatly impact all aspects of the Group as a whole and the
way that employees behave. A large part of the Group’s activities are centered upon addressing customer
and market needs. Therefore, the importance of sound ethical values and behaviour is crucial to the
ability of the Group to successfully achieve its corporate objectives.
The Board places great importance on this aspect of corporate life and seeks to ensure that this flows
through all that the Group does. The Board assessment of the culture within the Group at the present
time is one where there is respect for all individuals, there is open dialogue within the Group and there
is a commitment to provide the best service possible to all the Group’s key customers.
The Company operates in a manner that encourages an open and respectful dialogue with employees,
customers and other stakeholders and the Board considers that sound ethical values and behaviour are
crucial to the ability of the Company to achieve its corporate objectives. The Group is committed to the
highest standards of personal and professional ethical behaviour, and this must be reflected in every
aspect of the way in which the Company operates. The Board places great importance on this aspect of
corporate life and seeks to ensure that this flows through all that the Company does.
The Directors consider that at present the Group has an open culture facilitating comprehensive dialogue
and feedback and enabling positive and constructive challenge. The Executive Directors regularly meet
with senior management and discuss staff well-being, development and staff feedback. Employees are
encouraged to engage directly with Directors, and the Group seeks to promote Group values and
behaviour through a top-down approach.
The Board understands that the nature of its market, including high-end academic research universities
and hospitals, brings with it a level of public scrutiny in procurement. As such, the Board ensures there
is the utmost transparency and accessibility from the Board and external advisors that oversee the
Group’s activities.
Anti-Bribery Policy
The Group takes a zero-tolerance approach to bribery and corruption and is committed to acting
professionally, fairly and with integrity in all business dealings and relationships wherever they occur. The
Group implements effective systems to counter bribery and corruption and as part of this it has adopted
an anti-bribery and anti-corruption policy. The policy provides guidance to those working for the Group
on how to recognise and deal with bribery and corruption issues and the potential consequences and
applies to all persons working for the Group or on its behalf in any capacity, including employees at all
levels, directors, officers, consultants and agents.
Share Dealing
The Group has a Share Dealing Code, which will apply to any person discharging management
responsibility, including the Directors and members of the senior management team and any closely
associated persons and applicable employees.
Polarean Imaging plc
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Group Annual Report and Financial Statements
for the year ended 31 December 2022
Corporate Governance Statement (continued)
The Share Dealing Code imposes restrictions beyond those that are imposed by law (including by
Financial Services and Markets Act 2000 and the Market Abuse Regulation (EU) No.596/2014 as it forms
part of United Kingdom domestic law by virtue of the European Union (Withdrawal) Act 2018 and other
relevant legislation) and its purpose is to ensure that persons discharging managerial responsibility and
persons connected with them do not abuse, and do not place themselves under suspicion of abusing,
price-sensitive information that they may have or be thought to have, especially in periods leading up to
an announcement of both financial results and the results of the Group’s clinical trials. The Share Dealing
Code sets out a notification procedure which is required to be followed prior to any dealing in the
Company’s securities.
Communication with Shareholders
The Board is committed to maintaining good communication and having constructive dialogue with its
shareholders in order to maintain good investor relations and seeks, wherever possible to attain a
relationship of mutual understanding with both institutional and private client investors.
As such, Polarean takes a proactive approach to investor relations initiatives with ongoing support from
Walbrook PR Limited, the Group’s financial PR advisors. These investor relations initiatives include
(but are not limited to):
l shareholder events in London and elsewhere;
l the use of social media, in accordance with the Group’s Social Media Policy, and the Company’s
website; and
l interviews with platforms such as Proactive Investors around key developments.
Institutional shareholders and analysts have the opportunity to discuss issues and provide feedback at
meetings with the Company. In normal circumstances, attendance is actively encouraged for the
Company’s Annual General Meeting and any other General Meetings which are held throughout the year.
In line with best practise, should any resolution tabled at a General Meeting receive less than 80%
support, the Board will seek to engage with relevant shareholders to understand their reasons for voting
against. At the 2022 AGM, all resolutions passed with the support of at least 91% of the proxy votes
submitted.
The corporate governance arrangements that the Board has adopted are designed to ensure that the
Company delivers long-term value to its shareholders and that shareholders are able to express their
views and expectations for the Company in a manner that encourages open dialogue with the Board.
Polarean Imaging plc
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Group Annual Report and Financial Statements
for the year ended 31 December 2022
Remuneration Committee Report
Dear Shareholder,
As the Chairman of Polarean’s Remuneration Committee, I present my Remuneration Committee Report
for the year ended 31 December 2022, which has been prepared by the Committee and approved by
the Board.
The Remuneration Committee is responsible for determining the remuneration policy for the Executive
Directors, and for overseeing the Company’s long-term incentive plans. The Board as a whole is
responsible for determining Non-Executive Directors’ remuneration. The Committee will continue to
monitor market trends and developments in order to assess those relevant for the Group’s future
remuneration policy.
Remuneration policy for 2022 and future years
The Remuneration Committee determines the Company’s policy on the structure of Executive Directors’
and if required, senior management’s remuneration. The objectives of this policy are to:
l Reward Executive Directors and senior management in a manner that ensures that they are properly
incentivised and motivated to perform in the best interests of shareholders;
l Provide a level of remuneration required to attract and motivate high-calibre Executive Directors
and senior management of appropriate calibre;
l Encourage value creation through consistent and transparent alignment of incentive arrangements
with the agreed company strategy over the long term; and
l Ensure the total remuneration packages awarded to Executive Directors, comprising both
performance-related and non-performance-related remuneration, is designed to motivate the
individual, align interests with shareholders and comply with corporate governance best practice.
Objectives and Responsibilities
The Remuneration Committee’s main responsibilities can be summarised as follows:
l To determine the framework or broad policy for the remuneration of the Chairman, the Executive
Directors, and such other senior executives as it is requested by the Board to consider. The
remuneration of Non-Executive Directors shall be a matter for the Chairman and the Executive
Directors of the Board. No Director shall be involved in any decisions as to their own remuneration;
l To determine such remuneration policy, taking into account all factors which it deems necessary
(including relevant legal and regulatory requirements);
l To review the ongoing appropriateness and relevance of the remuneration policy, including policy
comparisons with market competitors;
l To design and determine targets for any performance related pay schemes operated by the
Company and approving the total annual payments made under such schemes;
l To review the design of, and any changes to, all share incentive plans;
l To advise on any major changes in employee benefits structures throughout the Company;
l To review the structure, size and composition of the Board, including the skills, knowledge and
experience;
l To give full consideration to succession planning;
l To recommend new Board appointments; and
l To consider any matter specifically referred to the Committee by the Board.
Polarean Imaging plc
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Group Annual Report and Financial Statements
for the year ended 31 December 2022
Remuneration Committee Report (continued)
Remuneration Policy for Non-Executive Directors
During the reporting period, Jonathan Allis, Cyrille Petit, Juergen Laucht, Kenneth West, Frank Schulkes,
Marcella Ruddy, M.D. and I each received a fee for our services as Directors, which had been approved
by the Board, and takes into account the time commitment and responsibilities of our roles and the current
market rates for comparable organisations and appointments.
Remuneration decisions for 2022
Bonuses payable for the year ended 31 December 2022 totalled US$503,576 (2021: US$375,861).
Remuneration Committee Effectiveness
The Committee is due to perform a self-assessment of its effectiveness during the second half of 2023.
Further information on Directors’ remuneration, including Directors’ emoluments, share options and
warrants holdings can be found in the Directors’ Report on pages 18 to 22.
Daniel Brague
Chairman of the Remuneration Committee
25 May 2023
Polarean Imaging plc
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Group Annual Report and Financial Statements
for the year ended 31 December 2022
Independent Auditors’ report to the members of Polarean Imaging plc
Opinion
We have audited the financial statements of Polarean Imaging plc (the “Parent Company”) and its
subsidiary (the “Group”) for the year ended 31 December 2022, which comprise:
l the Group statement of comprehensive income for the year ended 31 December 2022;
l the Group and parent company statements of financial position as at 31 December 2022;
l the Group and parent company statements of changes in equity for the year then ended;
l the Group and parent company statements of cash flows for the year then ended; and
l the notes to the financial statements, including a summary of significant accounting policies.
The financial reporting framework that has been applied in the preparation of the financial statements is
applicable law and UK adopted International Accounting Standards (UK IAS) and, as regards the parent
company, as applied in accordance with the provisions of the Companies Act 2006.
In our opinion:
l the financial statements give a true and fair view of the state of the Group’s and of Parent
Company’s affairs as at 31 December 2022 and of the Group’s loss for the year then ended;
l the Group’s financial statements have been properly prepared in accordance with UK IAS;
l the Parent Company financial statements have been properly prepared in accordance with UK IAS
as applied in accordance with the provisions of the Companies Act 2006; and
l 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 report. We are independent of the
Group 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 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.
Material uncertainty related to going concern
We draw attention to note 3 in the financial statements, which indicates that the Group anticipates needing
to raise additional capital by the end of the second quarter of 2024 to continue financing the Group’s
planned activities beyond the 12 months from the date of approval of these financial statements. As
stated in note 3, these events or conditions, along with the other matters as set forth in note 3, indicate
that a material uncertainty exists that may cast significant doubt on the Group and the Parent Company’s
ability to continue as a going concern. Our opinion is not modified in respect of this matter.
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 an assessment of the appropriateness of the
approach, assumptions and arithmetic accuracy of the model used by management when performing
their going concern assessment for a period of at least 12 months from the date of the approval of the
financial statements. We reviewed and challenged the underlying data and key assumptions used to
make the assessment. We reviewed and considered the potential downside scenarios and the resultant
impact on available funds, to assess the reasonableness of economic assumptions on the Group’s
liquidity requirements.
Polarean Imaging plc
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Group Annual Report and Financial Statements
for the year ended 31 December 2022
Independent Auditors’ report to the members of Polarean Imaging plc (continued)
Our responsibilities and the responsibilities of the Directors with respect to going concern are described
in the relevant sections of this report.
Overview of our audit approach
Materiality
In planning and performing our audit we applied the concept of materiality. An item is considered material
if it could reasonably be expected to change the economic decisions of a user of the financial statements.
We used the concept of materiality to both focus our testing and to evaluate the impact of misstatements
identified. Based on our professional judgement, we determined overall materiality for the Group financial
statements as a whole to be US$400,000 (2021: US$420,000), which represents approximately 3%
(2021: 3%) of the Group’s operating loss. We use a different level of materiality (‘performance materiality’)
to determine the extent of our testing for the audit of the financial statements.
Performance materiality is set based on the audit materiality as adjusted for the judgements made as to
the entity risk and our evaluation of the specific risk of each audit area having regard to the internal
control environment. We determined performance materiality to be US$280,000 (2021: US$295,000).
Where considered appropriate performance materiality may be reduced to a lower level, such as, for
related party transactions and directors’ remuneration.
We determined materiality for the Company financial statements as a whole was set at US$130,000
(2021: US$200,000) and its performance materiality to be US$91,000 (2021: US$140,000).
We agreed with the Audit Committee to report to it all identified errors in excess of US$13,000 (2021:
US$13,000). Errors below that threshold would also be reported to it if, in our opinion as auditor, disclosure
was required on qualitative grounds.
Overview of the scope of our audit
Polarean Imaging plc and its subsidiary are accounted for from one operating location in North Carolina,
USA. Our audit was conducted from the UK and the USA using a local sub-contractor as part of our
audit team under our direction and supervision. All Group companies were within the scope of our audit
testing.
Key Audit Matters
Key audit matters are those matters that, in our professional judgement, were of most significance in our
audit of the financial statements of the current period and include the most significant assessed risks of
material misstatement (whether or not due to fraud) that we identified. These matters included 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 financial statements as a whole, and in forming our opinion thereon, and we do not provide a
separate opinion on these matters.
In addition to the matter described in the material uncertainty in relation to going concern section, we
have determined the matters described below to be the key audit matters to be communicated in our
report. This is not a complete list of all risks identified by our audit.
Polarean Imaging plc
33
265964 Polarean_pp018-pp036.qxp 25/05/2023 19:38 Page 34
Group Annual Report and Financial Statements
for the year ended 31 December 2022
Independent Auditors’ report to the members of Polarean Imaging plc (continued)
Key audit matter – financial statements How the scope of our audit addressed
of the Group the key audit matter
Carrying value of intangible assets
At the reporting date the carrying value of
intangible assets, comprising patents, in the
financial statements of
the Group was
US$1.6million
(2021: US$2.2million). This
represented approximately 7% of the assets of the
Group at that date.
Our audit risk focuses on the risk that intangible
assets may be impaired.
Intangible assets are detailed in note 12. The
accounting policy is documented in note 3.
Carrying value of investment in subsidiary
and amounts receivable from subsidiary
At the reporting date the carrying value of
investment in subsidiary in the financial statements
of the parent company was US$4.3million (2021:
US$4.3million) and amounts receivable from
subsidiary
(2021:
US$53.8million). This represented approximately
97% of the assets of the parent company at that
date.
US$54.0million
was
We discussed with management whether any
indications of impairment existed. This includes
considering the remaining lives of patents, the
existence of any
technical
obsolescence of technology and manufacturing
processes, management’s future plans for the
business, the ability of the business to continue to
raise new investment and the market capitalisation
of the Group.
indication of
We reviewed the following sources of evidence:
l Board minutes, budgets and other operational
plans setting out the Group’s current plans for
the
continued commercial appraisal of
assets; and
l Reviewed the documentation with relevant
authority or regulator.
We discussed with management whether any
indications of impairment existed. This includes
considering the existence of any indication of
technical obsolescence of
technology and
manufacturing processes, management’s future
plans for the business, the ability of the business
to continue to raise new investment and the market
capitalisation of the Group.
Our audit risk focuses on the risk that the
recoverability of these balances may be impaired
if there are such indicators exist at year end.
Investments in, and amounts due from, subsidiary
are detailed in note 13. The relevant accounting
policies are documented in note 3.
Our audit procedures in relation to the above matter was designed in the context of our audit opinion as
a whole. They were not designed to enable us to express an opinion on these matters individually and
we express no such opinion.
Other information
The Directors are responsible for the other information. The other information comprises the information
included in the annual report, other than the financial statements and our auditor’s report thereon. 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.
Polarean Imaging plc
34
265964 Polarean_pp018-pp036.qxp 25/05/2023 19:38 Page 35
Group Annual Report and Financial Statements
for the year ended 31 December 2022
Independent Auditors’ report to the members of Polarean Imaging plc (continued)
In connection with our audit of the financial statements, 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 audit or otherwise appears to be materially misstated. If
we identify such material inconsistencies or apparent material misstatements, we are required to
determine whether there is a material misstatement in the financial statements or a material misstatement
of the other information. 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.
Opinion on other matter prescribed by the Companies Act 2006
In our opinion based on the work undertaken in the course of our audit
l 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
l 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 light of the knowledge and understanding of the Group and 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 where the Companies Act 2006 requires
us to report to you if, in our opinion:
l 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
l the parent company financial statements are not in agreement with the accounting records and
returns; or
l certain disclosures of directors' remuneration specified by law are not made; or
l we have not received all the information and explanations we require for our audit.
Responsibilities of the directors for the financial statements
As explained more fully in the directors’ responsibilities statement set out on page 22, 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 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.
Polarean Imaging plc
35
265964 Polarean_pp018-pp036.qxp 25/05/2023 19:38 Page 36
Group Annual Report and Financial Statements
for the year ended 31 December 2022
Independent Auditors’ report to the members of Polarean Imaging plc (continued)
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.
Irregularities, including fraud, are instances of non-compliance with laws and regulations. We design
procedures in line with our responsibilities, outlined above, to detect material misstatements in respect
of irregularities, including fraud. The extent to which our procedures are capable of detecting irregularities,
including fraud is detailed below:
We obtained an understanding of the legal and regulatory frameworks within which the Company
operates, focusing on those laws and regulations that have a direct effect on the determination of material
amounts and disclosures in the financial statements. The laws and regulations we considered in this
context were the Companies Act 2006 and taxation legislation. Technical, clinical or regulatory laws and
regulations which are inherent risks in the development of clinical drugs and devices are mitigated and
managed by the Chief Technology Officer and management generally in conjunction with expert
regulatory consultants in order to monitor the latest regulations and planned changes to the regulatory
environment.
We identified the greatest risk of material impact on the financial statements from irregularities, including
fraud, to be the override of controls by management. Our audit procedures to respond to these risks
included enquiries of management about their own identification and assessment of the risks of
irregularities, sample testing on the posting of journals and reviewing accounting estimates for biases.
Owing to the inherent limitations of an audit, there is an unavoidable risk that we may not have detected
some material misstatements in the financial statements, even though we have properly planned and
performed our audit in accordance with auditing standards. We are not responsible for preventing
non-compliance and cannot be expected to detect non-compliance with all laws and regulations.
These inherent limitations are particularly significant in the case of misstatement resulting from fraud as
this may involve sophisticated schemes designed to avoid detection, including deliberate failure to record
transactions, collusion or the provision of intentional misrepresentations.
A further description of our responsibilities for the audit of the financial statements is located on the
Financial Reporting Council’s website at: 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 Parent 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 Parent 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 Group and the Group's members as a body, for our audit work, for this report,
or for the opinions we have formed.
Matthew Stallabrass (Senior Statutory Auditor)
for and on behalf of
Crowe U.K. LLP
Statutory Auditor
London
25 May 2023
Polarean Imaging plc
36
265964 Polarean_pp037-pp043.qxp 25/05/2023 19:03 Page 37
Group Annual Report and Financial Statements
for the year ended 31 December 2022
Consolidated Statement of Comprehensive Income
Notes
2022
US$
2021
US$
Revenue
Cost of sales
Gross profit
Administrative expenses
Depreciation
Amortisation
Selling and distribution expenses
Share-based payment expense
Total operating costs
Operating loss
Finance income
Finance expense
Other gains/(losses) – net
Loss before tax
Taxation
Loss for the year and total other comprehensive expense
Loss per share
Basic and diluted (US$)
The results reflected above relate to continuing activities.
11
6
19
4
1,033,008
(684,732)
––––––––––––
348,276
––––––––––––
(8,464,766)
(277,461)
(760,780)
(3,310,592)
(1,205,247)
––––––––––––
1,185,427
(677,402)
––––––––––––
508,025
––––––––––––
(6,517,396)
(177,349)
(757,016)
(5,557,829)
(1,814,882)
––––––––––––
(14,018,846) (14,824,472)
––––––––––––
6 (13,670,570) (14,316,447)
2,587
7
(21,101)
7
318,957
7
––––––––––––
(13,905,596) (14,016,004)
–
––––––––––––
(13,905,596) (14,016,004)
35,045
(23,762)
(246,309)
––––––––––––
–
––––––––––––
––––––––––––
10
9
––––––––––––
(0.066)
––––––––––––
––––––––––––
(0.071)
––––––––––––
There are no items of Other Comprehensive Income (“OCI”) for the year other than the loss above and
therefore no separate statement of other comprehensive income has been presented.
The accompanying notes on pages 44 to 66 are an integral part of these financial statements.
Polarean Imaging plc
37
265964 Polarean_pp037-pp043.qxp 25/05/2023 19:03 Page 38
Group Annual Report and Financial Statements
for the year ended 31 December 2022
Consolidated Statement of Financial Position
ASSETS
Non-current assets
Property, plant and equipment
Intangible assets
Right-of-use assets
Trade and other receivables
Current assets
Inventories
Trade and other receivables
Cash and cash equivalents
TOTAL ASSETS
EQUITY AND LIABILITIES
Equity attributable to holders of the parent
Share capital
Share premium
Group re-organisation reserve
Share-based payment reserve
Accumulated losses
Non-current liabilities
Deferred income
Trade and other payables
Lease liability
Contingent consideration
Current liabilities
Trade and other payables
Lease liability
Deferred income
TOTAL EQUITY AND LIABILITIES
Notes
2022
US$
2021
US$
11
12
24
14
418,498
1,581,591
274,288
437,539
––––––––––––
2,711,916
––––––––––––
634,779
2,193,843
422,816
5,539
––––––––––––
3,256,977
––––––––––––
1,711,419
1,659,649
1,426,810
15
14
970,968
16 16,454,241 28,874,908
––––––––––––
––––––––––––
19,825,309 31,272,686
––––––––––––
––––––––––––
22,537,225 34,529,663
––––––––––––
––––––––––––
103,463
7,813,337
4,865,579
17
101,642
18 59,288,383 59,022,919
7,813,337
18
19
3,660,332
18 (52,765,804) (38,860,208)
––––––––––––
––––––––––––
19,304,958 31,738,022
––––––––––––
––––––––––––
21
22
24
20
22
24
21
128,704
360,000
216,691
316,000
––––––––––––
1,021,395
––––––––––––
145,747
–
358,837
316,000
––––––––––––
820,584
––––––––––––
1,731,114
1,979,001
130,949
142,146
108,994
89,725
––––––––––––
––––––––––––
1,971,057
2,210,872
––––––––––––
––––––––––––
22,537,225 34,529,663
––––––––––––
––––––––––––
––––––––––––
––––––––––––
These Financial Statements were approved and authorised for issue by the Board of Directors on 25 May
2023 and were signed on its behalf by:
Kenneth West
Non-Executive Chairman
Company number: 10442853
The accompanying notes on pages 44 to 66 are an integral part of these financial statements.
Polarean Imaging plc
38
265964 Polarean_pp037-pp043.qxp 25/05/2023 19:03 Page 39
Group Annual Report and Financial Statements
for the year ended 31 December 2022
Company Statement of Financial Position
ASSETS
Non-current assets
Investment in subsidiary
Current assets
Trade and other receivables
Cash and cash equivalents
TOTAL ASSETS
EQUITY AND LIABILITIES
Equity attributable to holders of the parent
Share capital
Share premium
Merger reserve
Share-based payment reserve
Accumulated losses
Notes
2022
US$
2021
US$
13 58,362,291 58,180,314
––––––––––––– –––––––––––––
58,362,291 58,180,314
––––––––––––– –––––––––––––
14
16
68,258
1,716,189
22,410
2,454,491
––––––––––––– –––––––––––––
2,476,901
––––––––––––– –––––––––––––
60,146,738 60,657,215
––––––––––––– –––––––––––––
––––––––––––– –––––––––––––
1,784,447
103,463
17
101,642
18 59,288,383 59,022,919
4,322,527
18
4,322,527
3,355,301
19
4,560,548
(8,288,811)
(6,251,190)
18
––––––––––––– –––––––––––––
59,986,110 60,551,199
––––––––––––– –––––––––––––
Current liabilities
Trade and other payables
22
TOTAL EQUITY AND LIABILITIES
160,628
160,628
106,016
––––––––––––– –––––––––––––
106,016
––––––––––––– –––––––––––––
60,146,738 60,657,215
––––––––––––– –––––––––––––
––––––––––––– –––––––––––––
As permitted by section 408 of the Companies Act 2006, no separate statement of Comprehensive
Income is presented in respect of the parent Company. The loss for the financial year dealt with in the
financial statements of the parent Company was US$2,037,621 (2021: US$2,128,845).
These financial statements were approved and authorised for issue by the Board of Directors on 25 May
2023 and were signed on its behalf by:
Kenneth West
Non-Executive Chairman
Company number: 10442853
The accompanying notes on pages 44 to 66 are an integral part of these financial statements.
Polarean Imaging plc
39
265964 Polarean_pp037-pp043.qxp 25/05/2023 19:03 Page 40
Group Annual Report and Financial Statements
for the year ended 31 December 2022
Consolidated Statement of Changes in Equity
Share-
based
Group
re-
Share
capital
US$
Share
premium
US$
payment organisation Accumulated
losses
reserve
US$
US$
reserve
US$
Total
equity
US$
As at 1 January 2021
78,200
––––––––––––
23,840,571
––––––––––––
1,845,450
––––––––––––
7,813,337
––––––––––––
(24,844,204)
––––––––––––
8,733,354
––––––––––––
Comprehensive income
Loss for the year
Transactions with owners
Issue of shares
Share issue costs
Share-based payment
expense
–
–
23,442
–
37,284,454
(2,102,106)
–
–
–
–
–
–
(14,016,004)
(14,016,004)
–
–
37,307,896
(2,102,106)
–
––––––––––––
–
––––––––––––
1,814,882
––––––––––––
–
––––––––––––
–
––––––––––––
1,814,882
––––––––––––
As at 31 December 2021
(audited)
101,642
––––––––––––
––––––––––––
59,022,919
––––––––––––
––––––––––––
3,660,332
––––––––––––
––––––––––––
7,813,337
––––––––––––
––––––––––––
(38,860,208)
––––––––––––
––––––––––––
31,738,022
––––––––––––
––––––––––––
Comprehensive income
Loss for the year
Transactions with owners
Issue of shares
Share-based payment
expense
As at 31 December 2022
–
–
1,821
265,464
–
–
–
–
(13,905,596)
(13,905,596)
–
267,285
–
––––––––––––
103,463
––––––––––––
––––––––––––
–
––––––––––––
59,288,383
––––––––––––
––––––––––––
1,205,247
––––––––––––
4,865,579
––––––––––––
––––––––––––
–
––––––––––––
7,813,337
––––––––––––
––––––––––––
–
––––––––––––
(52,765,804)
––––––––––––
––––––––––––
1,205,247
––––––––––––
19,304,958
––––––––––––
––––––––––––
The accompanying notes on pages 44 to 66 are an integral part of these financial statements.
Polarean Imaging plc
40
265964 Polarean_pp037-pp043.qxp 25/05/2023 19:03 Page 41
Group Annual Report and Financial Statements
for the year ended 31 December 2022
Company Statement of Changes in Equity
Share-
based
Group
re-
Share
capital
US$
Share
premium
US$
payment organisation Accumulated
losses
reserve
US$
US$
reserve
US$
Total
equity
US$
As at 1 January 2021
78,200
––––––––––––
23,840,571
––––––––––––
1,540,419
––––––––––––
4,322,527
––––––––––––
(4,122,345)
––––––––––––
25,659,372
––––––––––––
Comprehensive income
Loss for the year
Transactions with owners
Issue of shares
Share issue costs
Share-based payment
expense
As at 31 December 2021
(audited)
Comprehensive income
Loss for the year
Transactions with owners
Issue of shares
Share-based payment
expense
As at 31 December 2022
–
–
23,442
–
37,284,454
(2,102,106)
–
–
–
–
–
–
(2,128,845)
(2,128,845)
–
–
37,307,896
(2,102,106)
–
––––––––––––
–
––––––––––––
1,814,882
––––––––––––
–
––––––––––––
–
––––––––––––
1,814,882
––––––––––––
101,642
––––––––––––
––––––––––––
59,022,919
––––––––––––
––––––––––––
3,355,301
––––––––––––
––––––––––––
4,322,527
––––––––––––
––––––––––––
(6,251,190)
––––––––––––
––––––––––––
60,551,199
––––––––––––
––––––––––––
–
–
1,821
265,464
–
–
–
–
(2,037,621)
(2,037,621)
–
267,285
–
––––––––––––
103,463
––––––––––––
––––––––––––
–
––––––––––––
59,288,383
––––––––––––
––––––––––––
1,205,247
––––––––––––
4,560,548
––––––––––––
––––––––––––
–
––––––––––––
4,322,527
––––––––––––
––––––––––––
–
––––––––––––
(8,288,811)
––––––––––––
––––––––––––
1,205,247
––––––––––––
59,986,110
––––––––––––
––––––––––––
The accompanying notes on pages 44 to 66 are an integral part of these financial statements.
Polarean Imaging plc
41
265964 Polarean_pp037-pp043.qxp 25/05/2023 19:03 Page 42
Group Annual Report and Financial Statements
for the year ended 31 December 2022
Consolidated Statement of Cash Flows
Cash flows from operating activities
Loss before tax
Adjustments for non-cash/non-operating items:
Depreciation of property, plant and equipment
Amortisation of intangible assets and right-of use-assets
Loss on disposal of property, plant and equipment
Loss on remeasurement of right-of-use assets
Share-based payment expense
Net foreign exchange losses/(gains)
Finance expense
Finance income
Operating cash outflows before movements in working capital
Increase in inventories
Increase in trade and other receivables
Increase in trade and other payables
Decrease in deferred income
Net cash used in operations
Cash flows from investing activities
Purchase of property, plant and equipment
Net cash used in investing activities
Cash flows from financing activities
Issue of shares
Cost of issue
Interest paid on lease liabilities
Interest received
Principal elements of lease payments
Net cash generated by financing activities
Net (decrease)/increase in cash and cash equivalents
Cash and cash equivalents at the beginning of year
Effect of foreign exchange rate changes on cash and cash equivalents
Cash and cash equivalents at end of year
2022
US$
2021
US$
(13,905,596) (14,016,004)
277,461
760,780
2,766
–
1,205,247
246,309
23,762
(35,045)
177,349
757,015
590
11,660
1,814,882
(318,957)
21,101
(2,587)
––––––––––––– –––––––––––––
(11,424,316) (11,554,951)
––––––––––––– –––––––––––––
(448,886)
(622,901)
382,247
(5,976)
––––––––––––– –––––––––––––
(12,258,031) (12,250,467)
––––––––––––– –––––––––––––
(284,609)
(1,120,681)
607,887
(36,312)
(63,946)
(541,454)
––––––––––––– –––––––––––––
(541,454)
––––––––––––– –––––––––––––
(63,946)
–
(23,762)
35,045
(130,949)
267,285 37,307,896
(2,102,106)
(21,101)
2,587
(122,069)
––––––––––––– –––––––––––––
147,619 35,065,207
––––––––––––– –––––––––––––
(12,174,358) 22,273,286
––––––––––––– –––––––––––––
28,874,908
6,282,665
––––––––––––– –––––––––––––
318,957
––––––––––––– –––––––––––––
16,454,241 28,874,908
––––––––––––– –––––––––––––
––––––––––––– –––––––––––––
(246,309)
The accompanying notes on pages 44 to 66 are an integral part of these financial statements.
Polarean Imaging plc
42
265964 Polarean_pp037-pp043.qxp 25/05/2023 19:03 Page 43
Group Annual Report and Financial Statements
for the year ended 31 December 2022
Company Statement of Cash Flows
2022
US$
2021
US$
Cash flows from operating activities
Loss before tax (2,037,621)
Adjustments for non-cash/non-operating items:
Share-based payment expense 1,205,247
Net foreign exchange losses/(gains) 246,629
––––––––––––
Operating cash outflows before movements in working capital (585,745)
––––––––––––
(Increase)/decrease in trade and other receivables (45,848)
Increase in trade and other payables 54,612
––––––––––––
Net cash used by operations (576,981)
––––––––––––
Cash flows from financing activities
Issue of shares 267,285
Cost of issue –
Loans to the Subsidiary (181,977)
––––––––––––
Net cash generated by financing activities 85,308
––––––––––––
(2,128,845)
1,814,882
(319,564)
––––––––––––
(633,527)
––––––––––––
38,894
57,086
––––––––––––
(537,547)
––––––––––––
37,307,896
(2,102,106)
(33,444,587)
––––––––––––
1,761,203
––––––––––––
(Decrease)/increase in cash and cash equivalents (491,673)
––––––––––––
Cash and cash equivalents at the beginning of period 2,454,491
––––––––––––
Effect of foreign exchange rate changes on cash and cash equivalents (246,629)
––––––––––––
Cash and cash equivalents at end of period 1,716,189
––––––––––––
––––––––––––
1,223,656
––––––––––––
911,271
––––––––––––
319,564
––––––––––––
2,454,491
––––––––––––
––––––––––––
The accompanying notes on pages 44 to 66 are an integral part of these financial statements.
Polarean Imaging plc
43
265964 Polarean_pp044-pp066.qxp 25/05/2023 19:03 Page 44
Group Annual Report and Financial Statements
for the year ended 31 December 2022
Notes to the Financial Statements
1. General information
The Company is incorporated in England and Wales under the Companies Act 2006. The registered
number is 10442853 and its registered office is at 27-28 Eastcastle Street, London, W1W 8DH. The
Company is listed on the AIM market of the London Stock Exchange.
The Company is the parent company of Polarean, Inc (the “Subsidiary”, together the “Group”). The
principal activity of the Group is developing next generation medical imaging technology. The Subsidiary
is incorporated in the United States of America and has a registered office of 2500 Meridian Parkway
#175, Durham, NC 27713, USA.
2. Adoption of new and revised International Financial Reporting Standards
Standards and interpretations adopted during the year
Information on new standards, amendments and interpretations that are relevant to the Group’s annual
report and accounts is provided below:
l Onerous Contracts – Cost of Fulfilling a Contract (Amendments to IAS 37);
l Property, Plant and Equipment: Proceeds before Intended Use (Amendments to IAS 16);
l Annual Improvements to IFRS Standards 2018-2020 (Amendments to IFRS 1, IFRS 9, IFRS 16 and
IAS 41); and
l References to Conceptual Framework (Amendments to IFRS 3).
These standards have no material impact on the Group.
Standards, amendments and interpretations that are not yet effective
There are a number of standards, amendments to standards, and interpretations which have been issued
by the United Kingdom Endorsement Board (UKEB) that are effective in future accounting periods that
the Company has decided not to adopt early. These standards, amendments or interpretations are not
expected to have a material impact on the Group.
3. Significant accounting policies
Basis of preparation
These financial statements have been prepared in accordance with UK adopted International Accounting
Standards (“IFRS”) and under the historical cost convention. The financial statements are presented in
United States Dollars (“US$”) except where otherwise indicated.
The principal accounting policies adopted in the preparation of the financial statements are set out below.
The policies have been consistently applied to all the years presented, unless otherwise stated.
Going concern
The Group is moving from the development stage to full commercial exploitation of its IP. During the year
ended 31 December 2022 the Group recorded a loss after tax of US$13,905,596 (2021: loss of
US$14,016,004) and a net cash outflow from operating activities of US$12,258,031 (2021:
US$12,250,467).
The Directors have prepared financial projections and plans for a period of at least 12 months from the
date of approval of these financial statements. Based on the current management plan, management
believes that these funds are sufficient for the expenditure to date as well as the planned forecast
expenditure for the forthcoming 12 months.
Polarean Imaging plc
44
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Group Annual Report and Financial Statements
for the year ended 31 December 2022
Notes to the Financial Statements (continued)
3. Significant accounting policies continued
It is anticipated that additional capital will need to be raised by the end of the second quarter of 2024 in
order to continue to fund the Group’s activities at their planned levels beyond this date. This represents
a material uncertainty that may cast significant doubt about the Group’s and Company’s ability to continue
as a going concern. However, the Directors have a reasonable expectation that this uncertainty can be
managed to a successful outcome, and based on that assessment, the Group and Company will have
adequate resources to continue in operational existence for the foreseeable future. Accordingly, these
financial statements have been prepared on the going concern basis.
The financial statements do not reflect any adjustments that would be required to be made if they were
to be prepared on a basis other than the going concern basis.
Share capital
Ordinary shares are classified as equity. Incremental costs directly attributable to the issue of new shares
are shown in share premium as a deduction from the proceeds.
Inventory
Inventories are measured at the lower of cost and net realisable value. The cost of inventories is based
on the weighted average cost principle and includes expenditure incurred in inventories, adjusted for
rebates, and other costs incurred in bringing them to their existing location.
Cash and cash equivalents
Cash and cash equivalents comprise cash balances and call deposits with an original maturity of three
months or less.
Functional and presentation currency
Items included in the financial statements of the Group are measured using the currency of the primary
economic environment in which the Group operates (“the functional currency”). The financial statements
are presented in United States Dollars (US$) which is also the Group’s functional currency.
Foreign currencies
Transactions in foreign currencies are initially recorded by the Group’s entities at their respective
functional currency spot rates at the date the transaction first qualifies for recognition.
Monetary assets and liabilities denominated in foreign currencies are translated at the functional currency
spot rates of exchange at the reporting date.
Differences arising on settlement or translation of monetary items are recognised in profit or loss.
For the purpose of presenting the consolidated financial statements, the assets and liabilities of the
Group’s foreign operations are translated at exchange rates prevailing on the reporting date. Income and
expense items are translated at the average exchange rates for each period, unless exchange rates
fluctuate significantly during that period, in which case the exchange rates at the date of transaction are
used. All resulting exchange differences are recognised in “other comprehensive income” and
accumulated in equity.
Basis of consolidation
The consolidated financial statements are for the year ended 31 December 2022. The measurement
bases and principal accounting policies of the Group are set out below.
Polarean Imaging plc
45
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Group Annual Report and Financial Statements
for the year ended 31 December 2022
Notes to the Financial Statements (continued)
3. Significant accounting policies continued
On 30 May 2017 Polarean Merger-Sub, Inc., a Subsidiary of the Subsidiary, completed a merger process
under which it acquired substantially all of the assets of m2m Imaging Corp (“m2m”), a portfolio company
of Amphion Innovations plc engaged in the development of high-performance MRI RF coils for the global
research market, primarily in micro-imaging. By 2016 m2m had been inactive for several years due to an
inability to raise funds. At the date of the merger the assets of m2m were its technology and patents.
The merger was affected by way of court sanction in the process of which the Subsidiary acquired,
through a special purpose entity, Polarean Merger Sub, Inc. the assets of another special purpose entity,
m2m Merger Sub, Inc., with m2m Merger Sub, Inc. being the surviving entity. After the reporting date, on
1 September 2017, m2m Merger Sub, Inc. was merged into the Subsidiary with the Subsidiary being the
surviving entity, the effect being that m2m Merger Sub, Inc. was collapsed, and the Subsidiary had
acquired the m2m assets.
As part of the arrangements for the merger 576,430 shares in the Subsidiary were issued to the former
shareholders in m2m with the intention that all parties would exchange their stock in Polarean, Inc. for
shares in the Group on a pro rata basis as soon as practicable.
The Directors consider the merger between the Subsidiary and m2m Acquisition, Inc. as a consequence
of which the group acquired the exclusive worldwide rights to m2m’s technology and patents does not
meet the definition of an acquisition of a business as set out in IFRS3 and has therefore been accounted
for as the acquisition of an asset or a group of assets that does not constitute a business.
IFRS 3 requires that in such cases the acquirer shall identify and recognise the individual identifiable
assets acquired (including those assets that meet the definition of, and recognition criteria for, intangible
assets in IAS 38 Intangible assets) and to allocate the cost of the individual identifiable assets and
liabilities on the basis of their relative fair values at the date of purchase. Such a transaction or event
does not give rise to goodwill.
The fair value of the assets acquired under the merger arrangement of US$4,999,996 represents the
aggregate estimated value of the financial obligations of the former m2m shareholders which were
converted into equity in m2m prior to the merger agreement.
The Directors consider the acquisition of the entire issued common stock of the Subsidiary by the
Company in exchange for equivalent equity participation in the Company to be a group re-organisation
and not a business combination and to fall outside the scope of IFRS 3. Having considered the
requirements of IAS 8 and the relevant UK and US guidance, the transaction has been accounted for on
a merger or pooling of interest basis as if both entities had always been combined, using book values,
with no fair value adjustments made nor goodwill recognised.
Revenue recognition
Revenue comprises the fair value of the sale of goods and rendering of services to external customers,
net of applicable sales tax, rebates, promotions and returns.
Contracts and obligation
The majority of customer contracts have three main elements that the Group provides to the customer:
l Sale of polarisers;
l Sale of parts and upgrades; and
l Provision of service.
The sale of polarisers is seen as a distinct performance obligation and revenue is recognised at a point
in time. The customer can benefit from the use of the polarisers when supplied and is not reliant on the
Group to provide the parts and upgrades or service, and therefore revenue from the sale of polarisers is
recognised in full when the goods are delivered to the customer.
Polarean Imaging plc
46
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Group Annual Report and Financial Statements
for the year ended 31 December 2022
Notes to the Financial Statements (continued)
3. Significant accounting policies continued
The second performance obligation is the sale of parts and upgrades. The customer can benefit from
the use of the parts and upgrade when supplied and is not reliant on the Group to provide the service,
and therefore revenue from the sale of parts and upgrades is recognised in full when the goods are
delivered to the customer.
The third performance obligation is the provision of preventive maintenance service. Revenue from the
provision of preventive maintenance service is recognised over the period when the services are
rendered. A contract liability represents the obligation of the Group to render services to a customer for
which consideration has been received (or the amount is due) from the customer.
Determining the transaction price
The transaction price is determined as the fair value of the Group expects to receive over the course of
the contract.
There are no incentives given to customers that would have a material effect on the financial statements.
Allocate the transaction price to the performance obligations in the contract
The allocation of the transaction price to the performance obligations in the contract is non-complex for
the Group. There is a fixed unit price for each product or service sold. Therefore, there is limited judgement
involved in allocating the contract price to each unit ordered.
Recognise revenue when or as the entity satisfies its performance obligations
The overarching terms are consistent in each contract.
The sale of polarisers is seen as a distinct performance obligation and revenue is recognised at a point
in time, when title of the goods transferred to the customer, as the customer can benefit from the use of
the polarisers when supplied.
The sale of parts and upgrades is seen as a distinct performance obligation and revenue is recognised
at a point in time, when supplied to the customer, as the customer can benefit from the use of the parts
and upgrade when supplied.
The provision of service is seen as a distinct performance obligation and revenue is recognised as the
Group provides these services for the duration of the contract, i.e. over time. Any unexpired portion of a
service contract or payment received in advance in respect of service contracts either partially completed
or not started, are included in deferred income and released over their remaining term.
Property, plant and equipment
Owned assets
Items of property, plant and equipment are stated at cost or deemed cost less accumulated depreciation
and impairment losses. Cost includes the original purchase price of the asset and the costs attributable
to bringing the asset to its working condition for its intended use. When parts of an item of property, plant
and equipment have different useful lives, those components are accounted for as separate items of
property, plant and equipment.
Subsequent costs are included in the asset’s carrying amount or recognised as a separate asset, as
appropriate, only when it is probable that future economic benefits associated with the item will flow to
the Group and the cost of the item can be measured reliably.
Polarean Imaging plc
47
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Group Annual Report and Financial Statements
for the year ended 31 December 2022
Notes to the Financial Statements (continued)
3. Significant accounting policies continued
Depreciation
Depreciation is charged to profit or loss on a straight-line basis over the estimated useful lives of each
part of an item of property, plant and equipment. The estimated useful lives are as follows:
l Computer and IT equipment – 33% straight line
l Leasehold improvements – 20% straight line
l Laboratory equipment – 20% straight line
The residual values, useful lives and depreciation methods are reviewed, and adjusted if appropriate, or
if there is an indication of a significant change since the last reporting date.
Gains and losses on disposals are determined by comparing the proceeds with the carrying amount and
are recognised within administrative expenses in the statement of comprehensive income.
Intangible Assets
Patents and related rights are assessed by reviewing their net present value of future cash flows. Patents
are currently amortised over their useful life, not exceeding 10 years.
Internally generated intangible assets – research costs are costs incurred in research activities and are
recognised as an expense in the period in which they are incurred. An internally generated intangible
asset arising from the development of commercial technologies is recognised only if all of the following
conditions are met:
l it is probable that the asset will create future economic benefits;
l the development costs can be measured reliably;
l technical feasibility of completing the intangible asset can be demonstrated;
l there is the intention to complete the asset and use or sell it;
l there is the ability to use or sell the asset; and
l adequate technical, financial and other resources to complete the development and to use or sell
the asset are available.
At this time the Directors consider that the Group does not meet all of those conditions and development
costs are therefore recorded as expense in the period in which the cost is incurred.
Impairment of non-financial assets
Non-financial assets are reviewed for impairment whenever events or changes in circumstances indicate
that the carrying amount may not be recoverable. An impairment loss is recognised for the amount by
which the asset’s carrying amount exceeds its recoverable amount. The recoverable amount is the higher
of an asset’s fair value less costs to sell and value in use. For the purposes of assessing impairment,
assets are reviewed at the lowest levels for which there are separately identifiable cash flows
(cash-generating units).
Non-financial assets other than goodwill that suffered impairment are reviewed for possible reversal of
the impairment at each reporting date.
Polarean Imaging plc
48
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Group Annual Report and Financial Statements
for the year ended 31 December 2022
Notes to the Financial Statements (continued)
3. Significant accounting policies continued
Provisions
A provision is recognised in the statement of financial position when the Group has a present legal or
constructive obligation as a result of a past event, and it is probable that an outflow of economic benefits
will be required to settle the obligation. If the effect is material, provisions are determined by discounting
the expected future cash flows at a pre-tax rate that reflects current market assessments of the time
value of money and, when appropriate, the risks specific to the liability. The increase in the provision due
to the passage of time is recognised in finance costs.
Financial assets
The Group classifies all of its financial assets at amortised cost. Financial assets do not comprise
prepayments. Management determines the classification of its financial assets at initial recognition.
These assets arise principally from the provision of goods and services to customers (e.g. trade
receivables), but also incorporate other types of financial assets where the objective is to hold their assets
in order to collect contractual cash flows and the contractual cash flows are solely payments of the
principal and interest. They are initially recognised at fair value plus transaction costs that are directly
attributable to their acquisition or issue and are subsequently carried at amortised cost using the effective
interest rate method, less provision for impairment.
Amortised Cost
The Group's financial assets held at amortised cost comprise trade and other receivables and cash and
cash equivalents in the consolidated statement of financial position.
Impairment provisions for trade receivables are recognised based on the simplified approach within IFRS
9 using the lifetime expected credit losses. During this process the probability of the non-payment of the
trade receivables is assessed. This probability is then multiplied by the amount of the expected loss
arising from default to determine the lifetime expected credit loss for the trade receivables. For trade
receivables, which are reported net; such provisions are recorded in a separate provision account with
the loss being recognised within administrative expenses in the consolidated statement of comprehensive
income. On confirmation that the trade receivable will not be collectable, the gross carrying value of the
asset is written off against the associated provision.
Impairment provisions for other receivables are recognised based on the general impairment model
within IFRS 9. In doing so, the Company follows the 3-stage approach to expected credit losses. Step 1
is to estimate the probability that the debtor will default over the next 12 months. Step 2 considers if the
credit risk has increased significantly since initial recognition of the debtor. Finally, Step 3 considers if
the debtor is credit impaired, following the criteria under IAS 39.
Financial liabilities
The Group classifies its financial liabilities in the category of financial liabilities at amortised cost. All
financial liabilities are recognised in the statement of financial position when the Group becomes a party
to the contractual provision of the instrument.
Financial liabilities measured at amortised cost comprise trade payables and other short-dated monetary
liabilities, which are initially recognised at fair value and subsequently carried at amortised cost using
the effective interest rate method.
Unless otherwise indicated, the carrying values of the Group’s financial liabilities measured at amortised
cost represents a reasonable approximation of their fair values.
Polarean Imaging plc
49
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Group Annual Report and Financial Statements
for the year ended 31 December 2022
Notes to the Financial Statements (continued)
3. Significant accounting policies continued
Employee benefits: pension obligations
The Group operates a defined contribution plan. A defined contribution plan is a pension plan under
which the Group pays fixed contributions into a separate entity. The Group has no legal or constructive
obligations to pay further contributions if the fund does not hold sufficient assets to pay all employees
the benefits relating to employee service in the current and prior periods.
The Group has no further payment obligations once the contributions have been paid. The contributions
are recognised as employee benefit expense when they are due. Prepaid contributions are recognised
as an asset to the extent that a cash refund or a reduction in the future payments is available.
Finance costs
Finance costs comprise interest on lease liabilities; and are expensed using the effective interest method
in the period in which they are incurred.
Finance income
Finance income comprises interest income and dividend income.
Interest income is recognised in the income statement as it accrues using the effective interest method.
Other gains and losses – net
Other gains and losses comprise foreign exchange gains and losses on cash and cash equivalents.
Leases
Definition of a lease
The Group assesses whether a contract is or contains a lease. A contract is or contains a lease if the
contract conveys a right to control the use of an identified asset for a period of time in exchange for
consideration.
The Group recognises a right-of-use asset and a lease liability at the lease commencement date. The
right-of-use asset is initially measured at cost, and subsequently at cost less any accumulated
amortisation and impairment losses and adjusted for certain measurements of the lease liability.
Right-of-use assets are amortised on a straight-line basis over the remaining term of the lease or over
the remaining economic life of the asset if, rarely, this is judged to be shorter than the lease term.
The lease liability is initially measured at the present value of the lease payments that are not paid at
the commencement date, discounted using the interest rate implicit or, if that rate cannot be readily
determined, the Group’s incremental borrowing rate. Generally, the Group uses its incremental borrowing
rate as the discount rate.
The lease liability is subsequently increased by the interest cost on the lease liability and decreased by
lease payments made. It is remeasured when there is a change in future lease payments arising from a
change in an index or rate, a change in estimate of the amount expected to be payable under a residual
value guarantee, or as appropriate, changes in the assessment of whether a purchase or extension
option is reasonably certain to be exercised or a termination option is reasonably certain not to be
exercised.
The Group has applied judgement to determine the lease term for some lease contracts in which it is a
lease that include renewal options. The assessment of whether the Group is reasonably certain to
exercise such options impacts the lease term, which significantly affects the amount of lease liabilities
ad right-of-use assets recognised.
Polarean Imaging plc
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Group Annual Report and Financial Statements
for the year ended 31 December 2022
Notes to the Financial Statements (continued)
3. Significant accounting policies continued
As at 31 December 2022, potential future cash outflows of $479,477 (undiscounted) have not been
included in the lease liability because it is not reasonably certain that the leases will be extended (2021:
$421,142).
Income tax
Income tax for the years presented comprises current and deferred tax. Income tax is recognised in the
income statement except to the extent that it relates to items recognised directly in equity, in which case
it is recognised in equity. Current tax is the expected tax payable on the taxable income for the year, using
tax rates enacted or substantively enacted at the statement of financial position date, and any adjustment
to tax payable in respect of previous years.
Deferred tax is recognised on temporary differences arising between the tax bases of assets and
liabilities and their carrying amounts.
The following temporary differences are not recognised if they arise from a) the initial recognition of
goodwill, and b) for the initial recognition of other assets or liabilities in a transaction other than a business
combination that at the time of the transaction affects neither accounting nor taxable profit or loss.
Deferred tax is determined using tax rates and laws that have been enacted or substantially enacted by
the balance sheet date and are expected to apply when the related deferred tax asset is realised, or the
deferred income tax liability is settled.
A deferred tax asset is recognised only to the extent that it is probable that future taxable profits will be
available against which the asset can be utilised. Deferred tax assets are reduced to the extent that it is
no longer probable that the related tax benefit will be realised.
Deferred income tax assets and liabilities are offset when there is a legally enforceable right to offset
current tax assets against current tax liabilities and when the deferred income taxes assets and liabilities
relate to income taxes levied by the same taxation authority on either the taxable entity or different taxable
entities where there is an intention to settle the balances on a net basis.
Critical accounting estimates and judgements
The preparation of the Group’s financial statements under IFRS requires the directors to make estimates
and assumptions that affect the reported amounts of assets and liabilities and the disclosure of
contingent assets and liabilities. 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 directors consider that the following judgements are likely to have the most significant effect on the
amounts recognised in the financial statements.
Carrying value of intangible assets – Group
In determining whether there are indicators of impairment of the Group’s intangible assets, the directors
take into consideration various factors including the economic viability and expected future financial
performance of the asset and when it relates to the intangible assets arising on a business combination,
the expected future performance of the business acquired.
Carrying value of investments in and amounts receivable from subsidiaries – Company
In determining whether there are indicators of impairment of the Company’s investments in, and amounts
receivable from, its subsidiary undertakings, the directors take into consideration various factors including
the economic viability and expected future financial performance of the business of the subsidiary
undertakings.
Polarean Imaging plc
51
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Group Annual Report and Financial Statements
for the year ended 31 December 2022
Notes to the Financial Statements (continued)
4. Segmental information
IFRS 8 requires operating segments to be identified on the basis of internal reports about components
of the Group that are regularly reviewed by the chief operating decision maker (which takes the form of
the Board of Directors) as defined in IFRS 8, in order to allocate resources to the segment and to assess
its performance.
The chief operating decision maker has determined that the Group has one operating segment, the
development and commercialisation of gas polariser devices and ancillary instruments. Revenues are
reviewed based on the products and services provided: Polarisers, Parts and Upgrades, Service and
Other revenue.
The Group trades in Canada, Germany, the United Kingdom and the United States of America. Revenue
by origin of geographical segment for all entities in the Group is as follows:
Revenue
Canada
Germany
United Kingdom
United States of America
Total
Non-current assets
United States of America
Total
Product and services revenue analysis
Revenue
2022
US$
2021
US$
446,396
–
17,800
568,812
––––––––––––
1,033,008
––––––––––––
––––––––––––
529,824
6,750
25,183
623,670
––––––––––––
1,185,427
––––––––––––
––––––––––––
2022
US$
2021
US$
2,711,916
––––––––––––
2,711,916
––––––––––––
––––––––––––
3,256,977
––––––––––––
3,256,977
––––––––––––
––––––––––––
2022
US$
2021
US$
Polarisers
Parts and Upgrades
Service
826,059
275,789
83,579
––––––––––––
1,185,427
––––––––––––
––––––––––––
Management measures revenues by reference to the Group’s core services and products and related
services, which underpin such income.
759,099
155,787
118,122
––––––––––––
1,033,008
––––––––––––
––––––––––––
Total
Polarean Imaging plc
52
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Group Annual Report and Financial Statements
for the year ended 31 December 2022
Notes to the Financial Statements (continued)
5. Employees and Directors
Staff costs for the Group and the Company during the year:
Wages and salaries
Healthcare benefits
Social Security costs
Average monthly number of people (including directors) employed by activity:
Senior management including directors
R&D and clinical trial
Administration
Total
2022
US$
2021
US$
4,207,883
248,927
290,531
––––––––––––
4,747,341
––––––––––––
––––––––––––
3,604,758
220,476
248,063
––––––––––––
4,073,297
––––––––––––
––––––––––––
2022
No.
2021
No.
11
10
7
––––––––––––
28
––––––––––––
––––––––––––
10
11
7
––––––––––––
28
––––––––––––
––––––––––––
Key management compensation:
The following table details the aggregate compensation paid to key management personnel.
Salaries and fees
Healthcare benefits
Social security costs
2022
US$
2021
US$
1,527,810
85,025
70,311
––––––––––––
1,683,146
––––––––––––
––––––––––––
1,394,235
85,830
69,465
––––––––––––
1,549,530
––––––––––––
––––––––––––
Key management personnel include all directors who together have authority and responsibility for
planning, directing, and controlling the activities of the Group and senior divisional managers.
6. Operating loss
Depreciation
– Owned property, plant and equipment
Amortisation of right-of-use assets
Amortisation of intangible assets
Subtotal Amortisation
Research expenses
Auditors’ remuneration (note 8)
Clinical trial costs
Regulatory consulting costs
Legal and professional fees
Brand development and market research
Medical affairs and congress/symposia
Polarean Imaging plc
53
2022
US$
2021
US$
277,461
148,528
612,252
760,780
619,007
66,000
1,070,004
1,964,040
493,290
134,645
353,066
––––––––––––
––––––––––––
177,349
140,164
616,851
757,015
649,695
55,664
(52,599)
1,126,675
494,688
2,091,921
916,238
––––––––––––
––––––––––––
265964 Polarean_pp044-pp066.qxp 25/05/2023 19:03 Page 54
Group Annual Report and Financial Statements
for the year ended 31 December 2022
Notes to the Financial Statements (continued)
7. Other income and expense items
Finance income
Sundry income
Total finance income
Finance expense
Interest on lease liabilities
Total finance expense
Other gains and losses - net
Foreign exchange gains/(losses)
8. Auditor remuneration
Auditors’ remuneration
Fees payable to the Group’s auditor for audit of Parent Company
and Consolidated Financial Statements
2022
US$
2021
US$
35,045
––––––––––––
35,045
––––––––––––
––––––––––––
2,587
––––––––––––
2,587
––––––––––––
––––––––––––
23,762
––––––––––––
23,762
––––––––––––
––––––––––––
21,101
––––––––––––
21,101
––––––––––––
––––––––––––
2022
US$
2021
US$
(246,309)
––––––––––––
(246,309)
––––––––––––
––––––––––––
318,957
––––––––––––
318,957
––––––––––––
––––––––––––
2022
US$
2021
US$
66,000
––––––––––––
––––––––––––
55,664
––––––––––––
––––––––––––
9. Loss per share
The loss per share has been calculated using the loss for the year and the weighted average number of
ordinary shares outstanding during the year, as follows:
Loss for the year attributable to shareholders of the Group (US$)
Weighted average number of ordinary shares
Basic and diluted loss per share
2022
US$
2021
US$
(13,905,596) (14,016,004)
211,948,868 196,961,274
––––––––––––– –––––––––––––
(0.071)
––––––––––––
––––––––––––
(0.066)
––––––––––––
––––––––––––
For diluted loss per share, the weighted average number of ordinary shares in issue is adjusted to assume
conversion of all potential dilutive warrants, options and convertible loans over ordinary shares. Potential
ordinary shares resulting from the exercise of warrants, options and the conversion of convertible loans
have an anti-dilutive effect due to the Group being in a loss position. As a result, diluted loss per share is
disclosed as the same value as basic loss per share.
10. Taxation
There were no charges to income tax due to the losses incurred by the Group in the period.
Income taxes computed at the statutory federal income tax of 21% (2021: 21%) and the state income
tax of 2.5% (2021: 2.50%) UK corporation tax is calculated at 19% of the estimated assessable profits
for the year.
Polarean Imaging plc
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Group Annual Report and Financial Statements
for the year ended 31 December 2022
Notes to the Financial Statements (continued)
10. Taxation continued
Loss on ordinary activities before tax
Taxable permanent differences
Taxable loss on ordinary activities
Taxable loss on ordinary activities multiplied by the rate of
corporation tax in the US as above
Effects of:
Adjustments for rate of tax in other jurisdictions
Unrelieved tax losses carried forward
Total taxation charge
2022
US$
2021
US$
(13,905,596) (14,016,004)
(49,828)
––––––––––––
(14,160,589) (14,065,832)
(254,993)
––––––––––––
(2,973,724)
(2,953,825)
40,752
2,932,971
––––––––––––
–
––––––––––––
––––––––––––
42,577
2,911,248
––––––––––––
–
––––––––––––
––––––––––––
The tax reform act of 1986 contains provisions which limit the ability to utilise the net operating loss carry
forwards in the case of certain events including significant changes in ownership interests. If the Group’s
net operating loss carried forward, the Group would incur a federal income tax liability even though net
operating loss carry forwards would be available in future years.
The Group has tax losses carried forward of US$47,297,438 (2021: US$33,391,842). The unutilised tax
losses have not been recognised as a deferred tax asset due to uncertainty over the timing of future
profits and gains. In addition, there are approximately US$726,000 (2021: US$531,000) of unrecognised
deferred tax assets in respect of the share-based payment.
11. Property, plant and equipment
Cost
At 1 January 2021
Additions
Disposals
At 31 December 2021
Additions
Disposals
At 31 December 2022
Accumulated depreciation
At 1 January 2021
Depreciation expense
Disposals
At 31 December 2021
Depreciation expense
Disposals
At 31 December 2022
Carrying amount
At 31 December 2021
At 31 December 2022
Leasehold
improvements
US$
Furniture Computers
and IT
equipment
US$
and
equipment
US$
13,658
17,050
–
––––––––––––
30,708
3,500
–
––––––––––––
34,208
––––––––––––
6,068
7,934
–
––––––––––––
14,002
5,864
–
––––––––––––
19,866
––––––––––––
440,790
464,585
–
––––––––––––
905,375
52,470
–
––––––––––––
957,845
––––––––––––
213,012
146,656
–
––––––––––––
359,668
237,778
–
––––––––––––
597,446
––––––––––––
59,273
59,819
(1,328)
––––––––––––
117,764
7,976
(5,298)
––––––––––––
120,442
––––––––––––
23,377
22,759
(738)
––––––––––––
45,398
33,819
(2,532)
––––––––––––
76,685
––––––––––––
Total
US$
513,721
541,454
(1,328)
––––––––––––
1,053,847
63,946
(5,298)
––––––––––––
1,112,495
––––––––––––
242,457
177,349
(738)
––––––––––––
419,068
277,461
(2,532)
––––––––––––
693,997
––––––––––––
16,706
––––––––––––
––––––––––––
545,707
––––––––––––
––––––––––––
72,366
––––––––––––
––––––––––––
14,342
––––––––––––
––––––––––––
360,399
––––––––––––
––––––––––––
43,757
––––––––––––
––––––––––––
634,779
––––––––––––
––––––––––––
418,498
––––––––––––
––––––––––––
Polarean Imaging plc
55
265964 Polarean_pp044-pp066.qxp 25/05/2023 19:03 Page 56
Group Annual Report and Financial Statements
for the year ended 31 December 2022
Notes to the Financial Statements (continued)
12. Intangible assets
Cost
At 1 January 2021
Additions
At 31 December 2021
Additions
At 31 December 2022
Accumulated amortisation
At 1 January 2021
Amortisation expense
At 31 December 2021
Amortisation expense
At 31 December 2022
Carrying amount
At 31 December 2021
At 31 December 2022
Patents
US$
Total
US$
5,045,996
–
––––––––––––
5,045,996
––––––––––––
–
––––––––––––
5,045,996
––––––––––––
2,235,302
616,851
––––––––––––
2,852,153
––––––––––––
612,252
––––––––––––
3,464,405
––––––––––––
5,045,996
–
––––––––––––
5,045,996
––––––––––––
–
––––––––––––
5,045,996
––––––––––––
2,235,302
616,851
––––––––––––
2,852,153
––––––––––––
612,252
––––––––––––
3,464,405
––––––––––––
2,193,843
––––––––––––
––––––––––––
1,581,591
––––––––––––
––––––––––––
2,193,843
––––––––––––
––––––––––––
1,581,591
––––––––––––
––––––––––––
13. Investment in subsidiary undertaking
Amount due
Investment from
in subsidiary subsidiary
undertaking undertaking
Company US$ US$
Cost
At 31 December 2021 4,342,848 53,837,466
At 31 December 2022 4,342,848 54,019,443
–––––––––––– ––––––––––––
Carrying amount
At 31 December 2021 4,342,848 53,837,466
–––––––––––– ––––––––––––
At 31 December 2022 4,342,848 54,019,443
–––––––––––– ––––––––––––
Total
US$
58,180,314
58,362,291
––––––––––––
58,180,314
––––––––––––
58,362,291
––––––––––––
The investment in subsidiary undertaking is stated at cost less provision for impairment. The amount due
from subsidiary undertaking are regarded as net investment which is subject to the impairment
assessment whenever events or changes in circumstance indicate that the carrying value of the
investment and the amount due from subsidiary undertakings may not be recoverable. For the year under
review, there is no such indicator for impairment.
The net carrying amounts noted above relates to the Subsidiary. The subsidiary undertaking during the
year were as follows:
Country of Interest held
Registered office address incorporation %
Polarean Inc. 2500 Meridian Parkway #175, USA 100
Durham, NC 27713, USA
Polarean Imaging plc
56
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Group Annual Report and Financial Statements
for the year ended 31 December 2022
Notes to the Financial Statements (continued)
14. Trade and other receivables
Amounts falling due after one year
Rental deposit
Prepayments
Amounts falling due within one year
Trade receivables
Prepayments
Group
2022
US$
2021
US$
Company
2022
US$
2021
US$
5,539
432,000
––––––––––––
437,539
––––––––––––
––––––––––––
5,539
–
––––––––––––
5,539
––––––––––––
––––––––––––
–
–
––––––––––––
–
––––––––––––
––––––––––––
–
–
––––––––––––
–
––––––––––––
––––––––––––
Group
2022
US$
2021
US$
Company
2022
US$
2021
US$
109,397
1,550,252
––––––––––––
1,659,649
––––––––––––
––––––––––––
119,096
851,872
––––––––––––
970,968
––––––––––––
––––––––––––
–
68,258
––––––––––––
68,258
––––––––––––
––––––––––––
–
22,410
––––––––––––
22,410
––––––––––––
––––––––––––
Analysis of trade receivables based on age of invoices
< 30 31 – 60
$’000
$’000
2022 65,558
2021 73,500
–
–
61 – 90
$’000
–
45,097
> 90 Total Gross
$’000
$’000
43,839
499
109,397
119,096
ECL
$’000
–
–
Total Net
$’000
109,397
119,096
The Group applies the IFRS 9 simplified approach to measuring expected credit losses (ECL) which
uses a lifetime expected loss allowance for all trade receivables. The ECL balance has been determined
based on historical data available to management in addition to forward looking information utilising
management knowledge. The Company applies a similar approach to measuring ECL for the amounts
due from group undertakings.
Trade receivables are amounts due from customers for goods sold or services performed in the ordinary
course of business. They are generally due for settlement within 30 days and therefore are all classified
as current. The majority of trade and other receivables are non-interest bearing. Where the effect is
material, trade and other receivables are discounted using discount rates which reflect the relevant costs
of financing. The carrying amount of trade and other receivables approximates fair value.
15. Inventory
Finished Goods and Component parts
Group
2022
US$
2021
US$
1,711,419
––––––––––––
1,426,810
––––––––––––
During the year ended 31 December 2022, a total of US$597,736 of inventories was included in the
statement of comprehensive income as an expense (2021: US$624,507).
Polarean Imaging plc
57
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Group Annual Report and Financial Statements
for the year ended 31 December 2022
Notes to the Financial Statements (continued)
16. Cash and cash equivalents
Cash at bank and in hand
Group
2022
US$
2021
US$
Company
2022
US$
2021
US$
16,454,241 28,874,908
––––––––––––
––––––––––––
1,716,189
––––––––––––
2,454,491
––––––––––––
17. Share capital
The issued share capital of the Company was as follows:
Allotted and called up – Ordinary shares
of 0.037p each
2022
No.
2022
US$
2021
No.
2021
US$
At beginning of period
Issue of shares upon warrant exercise
Issue of shares to investors
Issue of shares upon option exercise
At end of year
209,249,966
–
–
3,797,543
78,200
474
22,881
87
–––––––––––––– ––––––––––––– ––––––––––––– –––––––––––––
213,047,509
101,642
–––––––––––––– ––––––––––––– ––––––––––––– –––––––––––––
101,642 163,212,935
–
928,089
– 44,932,142
176,800
103,463 209,249,966
1,821
On 24 February 2021, the Company issued 61,563 new ordinary shares upon the exercise of share
warrants with an exercise price of £0.15 each.
On 25 March 2021, the Company issued 358,713 new ordinary shares upon the exercise of share
warrants with an exercise price of £0.00037 each.
On 31 March 2021, 7 April 2021 and 8 April 2021 the Company issued a total of 44,932,142 new ordinary
shares of £0.00037 each in the capital of the Company at the issue price of 60 pence per share in a
Placing, Subscription and Open Offer for total proceeds of £27 million (before expenses).
On 16 April 2021, the Company issued 467,733 new ordinary shares upon the exercise of share warrants
with an exercise price of £0.00037 each.
On 17 May 2021, the Company issued 40,080 new ordinary shares upon the exercise of share warrants
with an exercise price of £0.00037 each.
On 23 November 2021, the Company issued 66,800 new ordinary shares upon the exercise of share
options with an exercise price of £0.025358 each.
On 9 December 2021, the Company issued 110,000 new ordinary shares upon the exercise of share
options with an exercise price of £0.15 each.
On 11 January 2022, the Company issued a total of 133,600 new ordinary shares upon the exercise of
share options with an exercise price of £0.02478 each.
On 11 January 2022, the Company issued a total of 132,630 new ordinary shares upon the exercise of
share options with an exercise price of £0.15 each.
On 01 February 2022, the Company issued a total of 109,356 new ordinary shares upon the exercise of
share options with an exercise price of £0.15 each.
On 05 April 2022, the Company issued a total of 2,057,440 new ordinary shares upon the exercise of
share options with an exercise price of £0.00313 each.
On 05 April 2022, the Company issued a total of 93,520 new ordinary shares upon the exercise of share
options with an exercise price of £0.02571 each.
Polarean Imaging plc
58
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Group Annual Report and Financial Statements
for the year ended 31 December 2022
Notes to the Financial Statements (continued)
17. Share capital continued
On 06 April 2022, the Company issued a total of 267,200 new ordinary shares upon the exercise of
share options with an exercise price of £0.00314 each.
On 20 April 2022, the Company issued a total of 260,169 new ordinary shares upon the exercise of
share options with an exercise price of £0.15 each.
On 20 April 2022, the Company issued a total of 136,109 new ordinary shares upon the exercise of
share options with an exercise price of £0.23 each.
On 22 July 2022, the Company issued a total of 534,400 new ordinary shares upon the exercise of share
options with an exercise price of £0.15 each.
On 27 July 2022, the Company issued a total of 73,119 new ordinary shares upon the exercise of share
options with an exercise price of £0.15 each.
18. Reserves
Share premium
Share premium represents the excess of subscription amounts for the issue of shares over nominal
value of shares issued, less any attributable share issue costs.
Group re-organisation reserve
The group re-organisation reserve arose on the transaction under which the Group acquired the
Subsidiary by way of a group re-organisation.
Share based payment reserve
Cumulative fair value of options charged to the consolidated income statement net of transfers to the
profit or loss reserve on exercised.
Accumulated losses
Includes all current and prior year retained profits and losses.
Merger reserve
The balance on the merger reserve represents the fair value of the consideration given in excess of the
nominal value of the ordinary shares issued in an acquisition made by the issue of shares where the
transaction qualifies for merger relief under the Companies Act 2006.
19. Share-based payments
Share options
The Company grants share options at its discretion to Directors, management and employees. These
are accounted for as equity settled transactions. Should the options remain unexercised after a period
of ten years from the date of grant the options will expire unless an extension is agreed to by the board.
Options are exercisable at a price equal to the Company’s quoted market price on the date of grant or
an exercise price to be determined by the board.
Polarean Imaging plc
59
265964 Polarean_pp044-pp066.qxp 25/05/2023 19:03 Page 60
Group Annual Report and Financial Statements
for the year ended 31 December 2022
Notes to the Financial Statements (continued)
19. Share-based payments continued
Details of share options granted, exercised, lapsed and outstanding at the year-end are as follows:
Outstanding at beginning of year
Granted during the year
Exercised during the year
Forfeited/lapsed during the year
Outstanding at end of the year
Exercisable at end of the year
Date Granted
08 March 2022
13 April 2022
04 May 2022
23 June 2022
25 August 2022
20 October 2022
Weighted
average
exercise
price
(US$)
2022
Number
of share
options
2021
0.50 16,884,322
8,580,000
0.71
(176,800)
0.07
(844,210)
0.99
––––––––––––
––––––––––––
0.51 24,443,312
––––––––––––
0.34 13,055,517
––––––––––––
––––––––––––
––––––––––––
Weighted
average
exercise
price
(US$)
2021
0.19
1.11
0.14
1.01
––––––––––––
0.50
––––––––––––
0.14
––––––––––––
Number of
share options
2022
24,443,312
1,941,000
(3,797,543)
(3,202,198)
––––––––––––
19,384,571
––––––––––––
13,751,273
––––––––––––
No. of options
Exercise price
Vesting conditions
70,000
500,000
500,000
246,000
573,000
52,000
––––––––––––
1,941,000
––––––––––––
52 pence
55 pence
52 pence
48 pence
61 pence
49 pence
Time-based1
Time-based1
Time-based1
Time-based1
Time-based1
Time-based1
125% of the options shall vest on the one-year anniversary of the employee’s date of hire with the
remaining 75% vesting in equal portions over the 36 months following the one-year anniversary of the
employee’s date of hire.
The options outstanding as at 31 December 2022 have an exercise price in the range of US$0.0041 to
US$1.19 (2021: US$0.0041 to US$1.19).
The fair value of options granted during the year has been calculated using the Black Scholes model
which has given rise to fair values per share of between US$0.23 and US$0.47. This is based on risk-free
rates of between 1.8% and 3.9%, volatility of between 58% and 80% and expected life of 4 years.
The Black Scholes calculations for the options resulted in a charge of US$1,205,247 (2021:
US$1,814,882) which has been expensed in the year. The weighted average remaining contractual life
of the share options is 6.37 years (2021: 6.85 years). The weighted average share price at the date of
exercise for all share options exercised during the period was US$0.75 (2021: $0.58). All share options
are equity settled on exercise.
Share warrants
The Company grants share warrants at its discretion to Directors, management, employees, advisors and
lenders. These are accounted for as equity settled transactions. Terms of warrants vary from agreement
to agreement.
Polarean Imaging plc
60
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Group Annual Report and Financial Statements
for the year ended 31 December 2022
Notes to the Financial Statements (continued)
19. Share-based payments continued
Details for the warrants granted, exercised, lapsed and outstanding at the year-end are as follows:
Outstanding at beginning of year
Exercised during the year
Forfeited/lapsed during the year
Outstanding at end of the year
Exercisable at end of the year
Weighted
average
exercise
price
(US$)
2022
Number
of share
options
2022
Weighted
average
exercise
price
(US$)
2021
Number
of share
options
2021
3,054,129
–
–
––––––––––––
3,054,129
––––––––––––
3,054,129
––––––––––––
0.01
–
–
––––––––––––
0.01
––––––––––––
0.01
––––––––––––
3,994,165
(928,089)
(11,947)
––––––––––––
3,054,129
––––––––––––
3.054,129
––––––––––––
0.09
0.34
0.34
––––––––––––
0.01
––––––––––––
0.01
––––––––––––
The weighted average remaining contractual life of the share warrants is 1.55 years (2021: 2.55 years).
The weighted average share price at the date of exercise for all share warrants exercised during the
period was US$nil (2021: US$0.68).
20. Provision for contingent consideration
Group
2022
US$
2021
US$
Company
2022
US$
2021
US$
Provision for contingent consideration 316,000 316,000 – –
––––––––––––– ––––––––––––– ––––––––––––– –––––––––––––
On 19 December 2011, the Subsidiary entered into an agreement with a third party to purchase various
assets, including patents, trademarks, a license agreement and physical inventory. As consideration for
this transaction, the Subsidiary agreed to pay 5 per cent. of gross revenue on clinical sales of products
that are sold related to the patents purchased, for seven years from the date of the commercial sale. As
of 31 December 2022, the fair value of this contingent consideration was US$316,000 (2021:
US$316,000). This liability is valued based on a probability weighted expected return method using
projected future cash flows. There were no significant events in the year ended 31 December 2022
necessitating revision of the probability weighted expected value of the contingent consideration.
There was therefore US$Nil profit or loss arising on revaluation of contingent consideration during the
year ended 31 December 2022 (2021: US$Nil).
21. Deferred income
Arising from service contracts
Balance brought forward
Additions
Revenue taken in year
Balance carried forward
Current
Non-current
Group
2022
US$
2021
US$
Company
2022
US$
2021
US$
254,741
69,809
(106,121)
260,717
77,603
(83,579)
–
––––––––––––– ––––––––––––– ––––––––––––– –––––––––––––
–
––––––––––––– ––––––––––––– ––––––––––––– –––––––––––––
254,741
218,429
–
–
–
–
89,725
128,704
108,994
145,747
–
–
––––––––––––– ––––––––––––– ––––––––––––– –––––––––––––
–
––––––––––––– ––––––––––––– ––––––––––––– –––––––––––––
254,741
218,429
–
–
–
Polarean Imaging plc
61
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Group Annual Report and Financial Statements
for the year ended 31 December 2022
Notes to the Financial Statements (continued)
22. Trade and other payables
Amounts falling due within one year
Trade payables
Accruals and other payables
Amounts falling due after one year
Accruals and other payables
Group
2022
US$
2021
US$
Company
2022
US$
2021
US$
597,363
1,381,638
––––––––––––
––––––––––––
405,953
1,325,161
––––––––––––
––––––––––––
45,861
114,767
––––––––––––
––––––––––––
1,979,001
––––––––––––
––––––––––––
1,731,114
––––––––––––
––––––––––––
160,628
––––––––––––
––––––––––––
40,887
65,129
––––––––––––
––––––––––––
106,016
––––––––––––
––––––––––––
Group
2022
US$
2021
US$
Company
2022
US$
2021
US$
360,000
––––––––––––
––––––––––––
–
––––––––––––
––––––––––––
–
––––––––––––
––––––––––––
–
––––––––––––
––––––––––––
Trade payables principally comprise amounts outstanding for trade purchases and ongoing costs and
are payable within 1 year.
The Directors consider the carrying value of all financial liabilities to be equivalent to their fair value.
23. Changes in liabilities from financing activities
Group
1 January
2021 Cash flows
US$
US$
Non-cash 31 December
2021
changes
US$
US$
Lease liability 221,428 (143,170) 411,528 489,786
––––––––––––– ––––––––––––– ––––––––––––– –––––––––––––
Total liabilities from financing activities 221,428 (143,170) 411,528 489,786
––––––––––––– ––––––––––––– ––––––––––––– –––––––––––––
1 January
2022 Cash flows
US$
US$
Non-cash 31 December
2022
changes
US$
US$
Lease liability 489,786 (154,710) 23,761 358,837
––––––––––––– ––––––––––––– ––––––––––––– –––––––––––––
Total liabilities from financing activities 489,786 (154,710) 23,761 358,837
––––––––––––– ––––––––––––– ––––––––––––– –––––––––––––
24. Leases
Nature of leasing activities
The group leases properties in the jurisdiction in which it operates with all lease payments fixed over the
lease term.
Number of active leases
2022
No.
2021
No.
2
––––––––––––
2
––––––––––––
The Group discounts the lease payments using its incremental borrowing rate at the commencement
date of the lease. The weighted-average rate applied is 10%.
Polarean Imaging plc
62
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Group Annual Report and Financial Statements
for the year ended 31 December 2022
Notes to the Financial Statements (continued)
24. Leases continued
Right-of-use assets
At 1 January 2021
Additions
Amortisation expense
At 31 December 2021
At 1 January 2022
Amortisation expense
At 31 December 2022
Lease Liabilities
At 1 January 2021
Additions
Interest expense
Lease payments
At 31 December 2021
At 1 January 2022
Interest expense
Lease payments
At 31 December 2022
Land and
Buildings
US$
184,213
378,767
(140,164)
––––––––––––
––––––––––––
422,816
––––––––––––
422,816
(148,528)
––––––––––––
274,288
––––––––––––
Land and
Buildings
US$
221,428
390,427
21,101
(143,170)
––––––––––––
489,786
––––––––––––
489,786
23,761
(154,710)
––––––––––––
358,837
––––––––––––
Analysis of lease liabilities
Maturity of the lease liabilities is analysed as follows:
Within 1 year
Later than 1 year and less than 5 years
25. Commitments
2022
US$
2021
US$
142,146
216,691
––––––––––––
358,837
––––––––––––
130,949
358,837
––––––––––––
489,786
––––––––––––
Royalty commitments
The Subsidiary has entered into three agreements requiring royalty payments. One agreement is
conditional and requires a payment of 5 per cent. of gross revenue on clinical sales during the payment
period beginning on the date a product is first commercially sold, contingent on receiving FDA approval,
and ending seven years from that date. A separate agreement requires payments of 0.25 per cent of
net sales of machines, and 20 per cent of any sublicensing income for a specific method of use of patent
beginning in 2016. Additionally, beginning five years after the effective date of 1 February 2021, there
are minimum yearly royalties of US$5,000. The third agreement requires a fixed payment of US$250,000
for use of patents.
Polarean Imaging plc
63
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Group Annual Report and Financial Statements
for the year ended 31 December 2022
Notes to the Financial Statements (continued)
26. Financial instruments
The Group has exposure to the following key risks related to financial instruments:
i. Market risk
ii. Credit risk
iii. Liquidity risk
This note presents information about the Group’s exposure to each of the above risks, the Group’s
objectives, policies and processes for measuring and managing risk, and the Group’s management of
capital. Further quantitative disclosures are included throughout these consolidated Financial Statements.
The Group uses financial instruments including cash, loans, as well as trade receivables and payables
that arise directly from operations.
Due to the simple nature of these financial instruments, there is no material difference between book
and fair values, discounting would not give a material difference to the results of the Group and the
Directors believe that there are no material sensitivities that require additional disclosure.
(a) Credit risk
Credit risk refers to the risk that a counterparty will default on its contractual obligations resulting in
financial loss to the Subsidiary. In order to minimise the risk, the Subsidiary endeavours only to deal
with companies which are demonstrably creditworthy and this, together with the aggregate financial
exposure, is continuously monitored. The maximum exposure to credit risk is the value of the
outstanding amount. The Group considers the banks and financial institutions have low credit risks.
Therefore, the Group is of the view that the loss allowance is immaterial and hence no provision is
required.
The Directors do not consider that there is any concentration of risk within either trade or other
receivables. There are no impairments to trade or other receivables in each of the years presented.
Categories of financial instruments
Financial assets at measured at
amortised cost
Group
2022
US$
2021
US$
Company
2022
US$
2021
US$
Cash and cash equivalents 16,454,241 28,874,908 1,716,189 2,454,491
Trade and other receivables – current 109,397 119,096 – –
Other receivables – non-current 5,539 5,539 – –
––––––––––––– ––––––––––––– ––––––––––––– –––––––––––––
Financial liabilities at measured at
amortised cost
––––––––––––– ––––––––––––– ––––––––––––– –––––––––––––
Trade and other payables- current 360,000 – – –
Other payables – non-current 1,979,001 1,731,114 160,629 106,016
––––––––––––– ––––––––––––– ––––––––––––– –––––––––––––
Capital risk management
The Group manages its capital to ensure that it will be able to continue as a going concern while
maximising returns to shareholders through the optimisation of capital structure. The Group is
funded by equity. Equity comprises share capital, share premium, share-based payment reserves,
group re-org reserves and accumulated losses and is presented in the statement of financial
position. In order to maintain or adjust the capital structure, the Group may adjust the amount of
dividends paid to shareholders, return capital to shareholders or issue new shares.
The Group manages the capital structure and makes adjustments to it in the light of changes to
economic conditions and risks.
Polarean Imaging plc
64
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Group Annual Report and Financial Statements
for the year ended 31 December 2022
Notes to the Financial Statements (continued)
26. Financial instruments continued
(b) Market risk
There is no interest risk exposure to the group or the company. The Company made unsecured
interest-free loans to its subsidiary and are expected to be repaid in the future as the subsidiary is
revenue generative.
(c) Liquidity risk
A maturity analysis of the Group’s financial liabilities is shown below:
Carrying Undiscounted
amounts
cash flow
2022
Less than
a year
1-2
years
2-5
years
Trade and other payables 2,339,001
Lease liabilities 358,837
–––––––––––––
2,697,838
–––––––––––––
2021
Trade and other payables 1,731,114
Lease liabilities 489,786
–––––––––––––
2,220,900
–––––––––––––
1,979,001
158,135
2,339,001
384,435
120,000
76,052
––––––––––––– ––––––––––––– ––––––––––––– –––––––––––––
76,052
––––––––––––– ––––––––––––– ––––––––––––– –––––––––––––
240,000
150,248
2,137,136
2,723,436
510,248
1,731,114
154,710
1,731,114
539,145
–
158,135
––––––––––––– ––––––––––––– –––––––––––––
158,135
1,885,824
–
226,300
–––––––––––
226,300
––––––––––––– ––––––––––––– ––––––––––––– –––––––––––––
2,270,259
Capital risk management
As highlighted earlier in these financial statements, the presentation currency of the Group is the US
dollar. The Group has foreign currency denominated assets and liabilities. Exposure to exchange rate
fluctuations therefore arises. The Group pays for invoices denominated in a foreign currency in the same
currency as the invoice and therefore suffers from a level of foreign currency risk, but this is immaterial.
The Group did not enter into any derivative financial instruments to manage its exposure to foreign
currency risk in the year.
The carrying amount of the Group's foreign currency denominated monetary assets and liabilities at
31 December 2022 is as follows:
British pound sterling
Cash balances
2022
USD $
2021
USD $
1,716,189
––––––––––––
1,716,189
––––––––––––
––––––––––––
2,454,491
––––––––––––
2,454,491
––––––––––––
––––––––––––
At 31 December 2022, if all foreign currencies in which the Group transacts had strengthened or
weakened by 10% against the US dollar with all other variables held constant, post-tax loss for the would
have been increased/(decreased) by:
Strengthened by 10% - increase in post-tax loss
Weakened by 10% - decrease in post-tax loss
2022
US$
2021
US$
171,619
––––––––––––
(171,619)
––––––––––––
––––––––––––
245,449
––––––––––––
(245,449)
––––––––––––
––––––––––––
Polarean Imaging plc
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Group Annual Report and Financial Statements
for the year ended 31 December 2022
Notes to the Financial Statements (continued)
26. Financial instruments continued
The rate of 10% is the sensitivity rate used when reporting foreign currency risk internally to key
management personnel and represents management's assessment of the reasonable possible change
in foreign exchange rates. The sensitivity analysis includes only outstanding foreign currency
denominated monetary items and adjusts their translation at year-end for a 10% change in foreign
currency rates. A positive number above indicates an increase in loss (increase in profit) or other equity
where the US$ strengthens by 10% against the relevant currency. For a 10% weakening of the US$
against the relevant currency, there would be an equal and opposite impact on the profit or loss and other
equity.
27. Contingent liabilities
The Directors are not aware of any material contingent liabilities, except for the contingent consideration
detailed in note 20.
28. Related party transactions
Remuneration of the key management personnel has been disclosed in Note 5.
29. Events after the reporting period
Between 1 January 2023 and 20 April 2023, the Company granted options over a total of 325,000
ordinary shares of £0.00037 each in the capital of the Company to three new employees. The options
vest over a four-year period and have an exercise price equal to the closing price on the date of grant.
On 17 April 2023, the Company announced the appointment of Daniel Brague, a Non-Executive Director
of the Company, as a consultant to the Company to provide strategic advice to the Company’s commercial
team. Under the terms of the consultancy contract, the Company will pay Mr. Brague an hourly fee of
$300. The fee is capped at $100,000 in total.
Polarean Imaging plc
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Notice of the Annual General Meeting
POLAREAN IMAGING PLC
(Incorporated in England and Wales under the Companies Act 2006 with company number 10442853)
NOTICE OF ANNUAL GENERAL MEETING
THIS DOCUMENT IS IMPORTANT AND REQUIRES YOUR IMMEDIATE ATTENTION
If you are in any doubt as to what action you should take, you are recommended to seek your
own financial advice from your stockbroker or other independent adviser authorised under the
Financial Services and Markets Act 2000.
If you have recently sold or transferred all of your shares in Polarean Imaging plc, please forward
this document, together with the accompanying documents, as soon as possible either to the
purchaser or transferee or to the person who arranged the sale or transfer so they can pass these
documents to the person who now holds the shares.
It is intended that the Annual General Meeting (the “AGM”) of Polarean Imaging plc (the “Company”) will be
held at the Company’s office at 2500 Meridian Parkway, Suite 175, Durham, NC 27713 USA at 2:00 p.m.
BST (9:00 a.m. EST) on 28 June 2023. The Company understand and recognises the importance of the
AGM and the Board greatly values the opportunity to meet shareholders in person. However, we understand
that this may not be possible or desirable for all whom wish to attend, therefore, the Company will offer
shareholders the option to participate in the AGM remotely via a Zoom conference call. If you wish to use
this facility, please contact the Company’ investors relations firm, Walbrook Public Relations, by emailing
polarean@walbrookpr.com who will provide further information. However, shareholders will not be able to
vote at the meeting when joining via the Zoom conference call. Shareholders are therefore asked, whether
or not they propose to attend the AGM, to exercise their votes and appoint the Chairman of the AGM as
their proxy by completing the form of proxy sent to them with this document and return it to the Company’s
registrars as soon as possible. They must receive it by 2:00 p.m. BST (9:00 a.m. EST) on 26 June 2023 (or,
in circumstances where the AGM is adjourned to a date later than 48 hours after the time specified for the
Meeting, 48 hours before the time of the adjourned meeting, excluding any UK non-working days).
NOTICE IS HEREBY GIVEN that the Annual General Meeting of Polarean Imaging plc (the
“Company”) will be held at the Company’s office at 2500 Meridian Parkway, Suite 175, Durham,
NC 27713 USA at 2:00 p.m. BST (9:00 a.m. EST) on 28 June 2023 for the purpose of considering
and, if thought fit, transacting the following business:
ORDINARY BUSINESS
To consider and, if thought fit, pass the following resolutions which will be proposed as ordinary
resolutions:
1.
2.
3.
4.
5.
To receive and consider the Company’s audited accounts for the year ended 31 December 2022
and the Directors’ of the Company (the “Director(s)”) and auditors’ reports thereon.
To consider and approve the remuneration report as detailed in the Company’s annual report and
accounts.
To re-appoint Crowe UK LLP as auditor of the Company (the “Auditor”) to hold office until the
conclusion of the next general meeting at which accounts are laid and to authorise the Directors to
fix the Auditor’s remuneration.
To re-elect Marcella Ruddy as a Director, who retires in accordance with article 78 of the Articles,
and who, being eligible, offers herself for re-election.
To re-elect Juergen Laucht as a Director, who retires in accordance with article 78 of the Articles,
and who, being eligible, offers himself for re-election.
Polarean Imaging plc
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Notice of the Annual General Meeting (continued)
6.
7.
8.
To re-elect Cyrille Petit as a Director, who retires in accordance with article 83 of the Articles, and
who, being eligible, offers himself for re-election.
To approve the amendments to the rules of the Polarean Imaging plc Share Option Plan (the “Plan”)
as further described on page 19 of the Annual Report and to authorise the Directors to do all such
other acts and things they may consider appropriate to implement the amended plan.
To generally and unconditionally authorise the Directors for the purpose of section 551 of the
Companies Act 2006 (the “Act”), in substitution for all existing authorities to the extent unused, to
exercise all the powers of the Company to allot or grant rights to subscribe for or to convert any
security into shares in the Company:
a)
b)
up to 10,000,000 ordinary shares of £0.00037 each (“Ordinary Shares”) in respect of the Plan;
and
otherwise than pursuant to paragraph (a) above, up to 31,957,126 Ordinary Shares (being
15 per cent. of the total number of Ordinary Shares in issue as at the date of this notice),
provided that this authority shall expire on the earlier of 15 months after the date of passing of
this resolution or the conclusion of the annual general meeting of the Company next following the
passing of this resolution, save that the Company may, before such expiry, make an offer or
agreement which would or might require shares or equity securities, as the case may be, to be
allotted or such rights granted after such expiry and the Directors may allot shares or equity
securities or grant such rights, as the case may be, in pursuance of such offer or agreement
notwithstanding that the authority conferred by this resolution has expired.
SPECIAL BUSINESS
To consider and, if thought fit, pass the following resolution as a special resolution:
9.
Subject to the passing of resolution 8 above, to empower the Directors, pursuant to the general
authority conferred on them and section 570 of the Act, to allot equity securities (within the meaning
of section 560 of the Act) for cash as if section 561 of the Act did not apply to any such allotment,
provided that this power shall be limited to the allotment of equity securities:
a) made in connection with an offer of securities, open for acceptance for a fixed period, to holders
of Ordinary Shares of the Company on the register on a fixed record date in proportion (as
nearly as may be) to their then holdings of such Ordinary Shares (but subject to such
exclusions or other arrangements as the Directors may deem necessary or expedient to deal
with any legal or practical problems under the laws or requirements of any recognised
regulatory body or any stock exchange in any overseas territory or in connection with fractional
entitlements); and/or
b) wholly for cash (otherwise than pursuant to paragraph 9(a) above) up to an aggregate number
of 31,957,126 Ordinary Shares.
This authority shall expire on the earlier of 15 months after the date of passing of this resolution
and the conclusion of the annual general meeting of the Company next following the passing of
this resolution but the Company may, before such expiry, make an offer or agreement which would
or might require shares or equity securities, as the case may be, to be allotted or such rights granted
after such expiry and the Directors may allot shares or equity securities or grant such rights, as the
case may be, in pursuance of such an offer or agreement notwithstanding that the power conferred
by this resolution has expired.
By Order of the Board
Stephen Austin Registered Office:
Company Secretary 27-28 Eastcastle Street
London
25 May 2023 W1Q 8DH
Polarean Imaging plc
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Notice of the Annual General Meeting (continued)
NOTES
A shareholder entitled to attend and vote at the meeting convened by this notice is entitled to appoint one or more proxies to
exercise all or any of their rights to attend, speak and vote on their behalf at the AGM. A proxy need not be a shareholder.
(1) Arrangements for the meeting
Shareholders who wish to attend the AGM in person should arrive at the venue in good time to allow their attendance to be
registered. Shareholders who wish to participate in the meeting remotely via the Zoom conference call should contact the
Company’s investor relations firm, Walbrook Public Relations, by emailing polarean@walbrookpr.com who will provide further
information. However, Shareholders will not be able to vote at the meeting when joining via the Zoom conference call. The
Board:
l
l
l
l
encourages Shareholders to submit their votes by proxy as early as possible, and Shareholders are encouraged to appoint
the Chairman of the meeting as their proxy. All proxy appointments should be received by no later than 2:00 p.m. BST on
26 June 2023;
strongly recommends CREST members to vote electronically through the CREST electronic proxy appointment service
as your vote will automatically be counted. In addition, the Company has also decided that proxy appointments can also
be submitted by Shareholders electronically (even outside CREST) by logging on to www.shareregistrars.uk.com, clicking
on the “Proxy Vote” button and then following the on-screen instructions (you can locate your log-in details on the top of
the proxy form). Please contact Share Registrars Limited contact number on +44 (0) 1252 821390 for any further
guidance. Dealing with paper proxies requires physical interaction such as post sorting and delivery, evaluation and
manual input.
proposes that voting at the meeting will be conducted by means of a poll on all resolutions, with each Shareholder having
one vote for each share held, thereby allowing all those proxy votes submitted and received prior to the meeting to be
counted; and
encourages you to submit any question that you would like to be answered at the meeting by sending it, together with
your name as shown on the Company’s register of members and the number of shares held, to the following email
address: polarean@walbrookpr.com so that it is received by no later than 2:00 p.m. BST on 26 June 2023. Please insert
“AGM – Shareholder Questions” in the subject header box of your email. The Company will endeavour to respond to all
questions received from Shareholders at the AGM or within seven days following the AGM.
(2) To appoint a proxy, shareholders should use the form of proxy enclosed with this notice of AGM. Please carefully read the
instructions on how to complete the form of proxy. For a proxy to be effective, the instrument appointing a proxy together with
the power of attorney or such other authority (if any) under which it is signed or a notarised certified copy of the same must
be deposited with the Company’s registrars, Share Registrars Limited of 3 The Millennium Centre, Crosby Way, Farnham,
Surrey, GU9 7XX, United Kingdom (the “Registrars”) or shareholders can submit their vote(s) by logging on to
www.shareregistrars.uk.com, clicking on the “Proxy Vote” button and then following the on-screen instructions (you can locate
your log-in details on the top of the proxy form) by 2:00 p.m. BST on 26 June 2023, or, if the AGM is adjourned, 48 hours
before the time fixed for the adjourned meeting (excluding any part of a day that is not a business day). The completion and
return of a form of proxy does not preclude a shareholder from subsequently attending and voting at the AGM in person if he
or she so wishes. If a shareholder has appointed a proxy and attends the AGM in person, such proxy appointment will
automatically be terminated.
(3) Pursuant to Regulation 41 of Uncertificated Securities Regulations 2001, the Company specifies that only those shareholders
on the register of members at 2:00 p.m. BST on 26 June 2023 or, if the meeting is adjourned, 48 hours before the time of the
adjourned meeting (excluding any part of a day that is not a business day), shall be entitled to attend or vote at the AGM in
respect of the number of ordinary shares of £0.00037 each (the “Ordinary Shares”) registered in their name at that time.
Changes to the register of members after that time shall be disregarded in determining the rights of any person to attend or
vote at the AGM.
(4) Any Shareholder may insert the full name of a proxy or the full names of two alternative proxies of the Shareholder’s choice
in the space provided with or without deleting ‘the Chairman of the meeting.’ A proxy need not be a Shareholder but must
attend the meeting to represent the relevant Shareholder. The person whose name appears first on the Form of Proxy and
has not been deleted will be entitled to act as proxy to the exclusion of those whose names follow. If this proxy form is signed
and returned with no name inserted in the space provided for that purpose, the Chairman of the meeting will be deemed to
be the appointed proxy. Where a Shareholder appoints as his/her proxy someone other than the Chairman, the relevant
Shareholder is responsible for ensuring that the proxy attends the meeting and is aware of the Shareholder’s voting intentions.
Any alteration, deletion or correction made in the Form of Proxy must be initialled by the signatory/ies.
(5) A shareholder may appoint more than one proxy provided that each proxy is appointed to exercise the rights attached to a
different Ordinary Share or Ordinary Shares held by that shareholder. A shareholder may not appoint more than one proxy to
exercise rights attached to any one Ordinary Share. If a shareholder wishes to appoint more than one proxy, they should
contact the Registrars on 01252 821390, +44 1252 821390 from overseas. Lines are open from 9.00 a.m. to 5.00 p.m. Monday
to Friday, excluding public holidays. Alternatively, you may write to the Registrars at Share Registrars Limited, 3 The Millennium
Centre, Crosby Way, Farnham, Surrey, GU9 7XX, United Kingdom for additional proxy forms and for assistance.
(6) Any corporation which is a shareholder can appoint one or more corporate representatives who may exercise on its behalf
all of its powers as a shareholder provided that they do not do so in relation to the same Ordinary Share.
Polarean Imaging plc
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Notice of the Annual General Meeting (continued)
(7) As at the close of business on the date immediately preceding this notice, the Company’s issued share capital comprised
213,047,509 Ordinary Shares. Each Ordinary Share carries the right to vote at the AGM and, therefore, the total number of
voting rights in the Company as at close of business on the date immediately preceding this notice is 213,047,509.
(8) A shareholder’s instructions to the proxy must be indicated in the appropriate space provided. To abstain from voting on a
resolution, select the relevant ‘Vote withheld’ box. A vote withheld is not a vote in law, which means that the vote will not be
counted in the calculation of votes for or against the resolution. If no voting indication is given, your proxy will vote or abstain
from voting at his or her discretion. Your proxy will vote (or abstain from voting) as he or she thinks fit in relation to any other
matter which is put before the meeting.
(9) This form of proxy must be signed by the appointor, or his attorney duly authorised in writing. The power of attorney or other
authority (if any) under which the form of proxy is signed, or a notarised certified copy of the power or authority, must be
received by the Registrars with the form of proxy. If the appointor is a corporation, the form of proxy should be signed on its
behalf by an attorney or duly authorised officer or executed as a deed or executed under common seal. In the case of joint
holders, the signature of any one of them will suffice, but the names of all joint holders should be stated.
(10) CREST members who wish to appoint a proxy or proxies through the CREST Electronic Proxy Appointment Service may do
so for the AGM to be held at 2:00 p.m. BST on 28 June 2023 and any adjournment(s) thereof by following the procedures
described in the CREST manual. All messages relating to the appointment of a proxy or an instruction to a previously appointed
proxy, which are to be transmitted through CREST, must be received by the Registrars (ID 7RA36) no later than 2:00 p.m. BST
on 26 June 2023, or, if the AGM is adjourned, 48 hours before the time fixed for the adjourned meeting (excluding any part of
a day that is not a business day).
(11) In order to revoke a proxy instruction, you will need to inform the Company by sending a signed hard copy notice clearly stating
your intention to revoke your proxy appointment to the Registrars. In the case of a shareholder which is a company, the
revocation notice must be executed in accordance with note 12 below. Any power of attorney or any other authority under
which the revocation notice is signed (or a duly certified copy of such power or authority) must be included with the revocation
notice and must be received by the Registrars not less than 48 hours (excluding any part of a day that is not a business day)
before the time fixed for the holding of the AGM or any adjourned meeting (or in the case of a poll before the time appointed
for taking the poll) at which the proxy is to attend, speak and to vote. If you attempt to revoke your proxy appointment but the
revocation is received after the time specified then, subject to the paragraph directly below, your proxy appointment will remain
valid.
(12) A corporation’s form of proxy must be executed under either its common seal, if any, or under the hand of a duly authorised
officer or attorney, in each case as required under the laws of its relevant jurisdiction.
Polarean Imaging plc
70
Perivan.com
Polarean Imaging Plc
Group Annual Report & Accounts 2022
Company Number 10442853
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