Company registration number 08773116 (England and Wales)
BLUE EARTH DIAGNOSTICS LIMITED
ANNUAL REPORT AND FINANCIAL STATEMENTS
FOR THE YEAR ENDED 31 DECEMBER 2023
BLUE EARTH DIAGNOSTICS LIMITED
COMPANY INFORMATION
Directors
Mr R Desimini
Mr C Y Petit
Mr F R Bracco
Mr F Tedoldi
Mr A Vismara
Dr D E Gauden
Secretary
Ms C Roche
Company number
08773116
Registered office
Magdalen Centre
The Oxford Science Park
Oxford
Oxfordshire
UK
OX4 4GA
Auditor
Azets Audit Services
Suites B & D
Burnham Yard
London End
Beaconsfield
Buckinghamshire
United Kingdom
HP9 2JH
BLUE EARTH DIAGNOSTICS LIMITED
CONTENTS
Page
Strategic report
1 - 4
Directors' report
5 - 7
Independent auditor's report
8 - 10
Statement of comprehensive income
11
Balance sheet
12
Statement of changes in equity
13
Notes to the financial statements
14 - 28
BLUE EARTH DIAGNOSTICS LIMITED
STRATEGIC REPORT
FOR THE YEAR ENDED 31 DECEMBER 2023
- 1 -

The directors present the strategic report for the year ended 31 December 2023.

 

Principal Activities

 

Blue Earth Diagnostics Limited was founded in March 2014 to develop and commercialise molecular imaging agents, addressing areas of high unmet medical need in cancer care. The company’s first approved and commercially available product, Axumin® (18F fluciclovine), a novel molecular imaging agent, images cancer cells using PET (Position Emission Tomography). Furthermore, in May 2023 the Company’s second product, POSLUMA® (flotufolastat F 18), got FDA approval and was commercially launched in June 2023. POSLUMA® (flotufolastat F 18) is indicated for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer with suspected metastasis who are candidates for initial definitive therapy or with suspected recurrence based on elevated serum prostate-specific antigen (PSA) level.

 

The Company’s key focus areas are product development, licensing and commercialisation. The Blue Earth Diagnostics commercial model is to work with leading manufacturers and distributors of radiolabeled imaging agents. Blue Earth Diagnostics engages with genito-urinary oncologists in cancer clinical trials, provides application training and medical affairs support. Blue Earth Diagnostics is partnered with PETNET Solutions Inc., a wholly owned subsidiary of Siemens Medical Solutions USA, Inc., which operates the largest network of PET radio pharmacies in the US. In Europe, the Company has a few radiopharmaceutical manufacturing and distribution partners.

 

Company Strategy

 

Blue Earth Diagnostics launched POSLUMA® (flotufolastat F 18) in the US in 2023 and plans to launch flotufolastat (18F) in Europe and other countries as well through commercial partnerships. POSLUMA is manufactured in 36 manufacturing sites in the US through a single manufacturing and distribution partner. Axumin® (fluciclovine F 18) is still manufactured in the US, Europe and selected other countries with limited utilization for the original indication of recurrent prostate cancer. Additional indications for 18F-fluciclovine are being progressed, the most advanced of which is used in diagnosing and characterising cancer metastases in the brain that has spread from other primary tumours.

 

The Company has worldwide rights to investigational Fibroblast Activation Protein (FAP)‐targeted imaging agents that are in early-stage development. These imaging agents have been shown to have the potential to improve lesion characterization in various cancer types. The Company will continue portfolio expansion activities for differentiated targeted molecular imaging agents.

Fair review of the business

In 2023, the Company continued to face competitive headwinds from in-market PSMA (Prostate Specific Membrane Antigen) products, notably Pylarify(R) from Lantheus and Illuccix(R) from Telix. Axumin(R) (fluciclovine F 18) injection sales continued to decline in the US. POSLUMA(R) (flotufolastat F 18) injection, formerly referred to as rhPSMA-7.3, was approved on 26 May 2023. This approval represented a major milestone for PET manufacturing approvals due to the fact that this approval included an unprecedented 31 manufacturing sites, well above the typical 2-3 manufacturing sites included in a New Drug Application (NDA) with the Food and Drug Administration (FDA); the number of manufacturing sites was increased to 36 by end of 2023. Coding and reimbursement for POSLUMA did not take full effect until January 2024 and as a result, the sales of POSLUMA in the US were significantly lower than forecasted in 2023. In late 2023, the Company undertook a full go-to-market strategy analysis and consequently agreed in December to make changes in 2024.

 

Several named patient supply (NPS) programs were established in Europe during 2023. Under one of these NPS programs, over 70 doses were provided to the Dutch market. In addition, a number of out-license partnership deals were signed to expand the use of flotufolastat (F 18) globally. This includes Global Medical Solutions (GMS) for the Taiwanese market, Sinotau for the Chinese market, and DuChemBio for the South Korean market. All of the partner companies will be responsible for the market authorisation for their respective markets. These partnerships will benefit the Company by earning revenue through a combination of milestone and royalty payments.

 

During 2023, the Company has continued to heavily invest in R&D, despite the spending slightly decreasing to $19.5m vs. $25.3m in 2022. The decrease in R&D costs in 2023 was due to higher spending in the prior years for the study completion and NDA submission to the FDA for POSLUMA® (flotufolastat F 18).

BLUE EARTH DIAGNOSTICS LIMITED
STRATEGIC REPORT (CONTINUED)
FOR THE YEAR ENDED 31 DECEMBER 2023
- 2 -

Approximately 18 individuals in the US (predominantly Medical Affairs support) and 26 in Europe are employed in R&D-focused activities encompassing chemistry development, pre-clinical and clinical research.

 

The Company received approval for its prostate cancer agent, POSLUMA® (flotufolastat F 18), from the US Food and Drug Administration (FDA). POSLUMA was added to the National Comprehensive Cancer Network® (“NCCN”) Clinical Practice Guidelines in Oncology for Prostate Cancer. The NCCN Guidelines state that POSLUMA PET should be considered in the clinical workup of patients with newly diagnosed or recurrence of their prostate cancer.

During 2023, the Company continued research into the use of 18F-fluciclovine in brain metastases, with a supplemental NDA (sNDA) expected in the near future.

 

The Company have worldwide rights to investigational Fibroblast Activation Protein (FAP)‐targeted technology for diagnostic PET imaging. These imaging agents are in early-stage development and have been shown to have the potential to improve lesion characterization in various cancer types. A Phase 1 study was initiated, in collaboration with an industry partner, investigating the safety and efficacy of the lead candidate FAP agent.

 

Key performance indicators

 

The most relevant indicators for the business for 2023 were:

 

Turnover decreased by $77.3m (2023 revenue $14.1m vs 2022 revenue $91.4m)

Gross profit decreased by $62.9m (2023 gross loss $8.7m vs 2022 gross profit $54.2m)

 

The reason for this decrease was due to a delay in coding and reimbursement for POSLUMA which did not take full effect until January 2024 and as a result, the sales of POSLUMA in the US were significantly lower than forecasted in 2023.

 

Principal Risks and Uncertainties

 

The Company periodically measures the risks to which it is potentially exposed and designs the organisational, regulatory, operational and strategic measures needed to mitigate these risks to a level considered acceptable according to quantitative and qualitative parameters. The Company monitors performance and cash generation through regular financial reporting, short-term forecasts, budgets and long term strategic plans, together with monthly and quarterly formal business reviews, including Board of Director meetings with the principal shareholder. Additionally, there are periodic finance performance reviews at local and Bracco corporate levels.

 

Section 172(1) statement

 

When making decisions, the Directors of the Blue Earth Diagnostics Limited (“BED”) must act in a way they consider, in good faith, is most likely to promote the success of the Company for the benefit of its members, while also considering the broad range of stakeholders who interact with and are impacted by our business. Throughout the year, while discharging their duties, section 172(1) requires a director to have regard, amongst other matters, to the:

•    likely consequences of any decisions in the long term;

•    interests of the company’s employees;

•    need to foster the company’s business relationships with suppliers, customers, and others;

•    impact of the company’s operations on the community and environment; and

•    desirability of the company maintaining a reputation for high standards of business conduct;

 

In discharging our s.172(1) duties we have had regard to the factors set out above, as well as other factors considered relevant to the decisions being made. For example, with reference to the likely consequences of any decision in the long term, the company this year made significant R&D investments and developed partnerships to support the PET oncology pipeline long term. Furthermore, from a commercial and marketing prospective, the company is assessing and developing new territories, to deploy the current and future product portfolio. We acknowledge that every decision made will not necessarily result in a positive outcome for all stakeholders.

BLUE EARTH DIAGNOSTICS LIMITED
STRATEGIC REPORT (CONTINUED)
FOR THE YEAR ENDED 31 DECEMBER 2023
- 3 -

By considering the Company’s Purpose, Vision and Values, together with its strategic priorities, we aim to ensure that the decisions made are consistent and intended to promote the Company’s long-term success.

Authority for the day-to-day management of the Company is delegated to senior management in setting, approving and overseeing the execution of the business strategy and related policies. We review matters relating to: financial and operational performance; business strategy; key risks; stakeholder-related matters; health and safety; diversity and inclusivity; environmental matters; corporate responsibility; governance; compliance; and legal and regulatory matters over the course of the financial year. This is done through the consideration of reports which are sent in advance of each Board meeting and through presentations to the Board.

Examples of how the Directors have engaged with the Company’s stakeholders with regard to section 172(1) (a) to (f) are detailed below:

Shareholders:

Our ultimate shareholders, through our parent company, are in regular communication with the Board. Performance metrics and updates are provided through established mechanisms. The BED Board meets regularly with Bracco Imaging Spa. The Board has embraced the company’s vision and strategy to maximise shareholder value, through empowering the evolution of care of patients with cancer. The company is committed to improving the lives of patients through innovative imaging solutions that optimize cancer care.

Employees:

The Board strives to maintain and develop a culture where everyone feels valued and included. The Board has engaged with employees via a variety of channels. Regular “Town Hall” meetings have taken place, both virtually and in-person, where the Board has shared its strategic vision, where employees can learn about the patient journey and where Q&A sessions are delivered. Feedback from employees is actively encouraged and is considered a key driver in developing our business activities, processes and workplace environment. Initiatives to encourage wellbeing are well established and continue to evolve and are strongly influenced by the workforce. Together with regular employee communication, Town Hall sessions included specific update presentation on the latest government guidelines and updates and adherence of these, information on health and safety, operational, and general mental and physical wellbeing. Professional and personal development of employees is viewed as fundamental to the continued success of the Company and our revised Development & Performance Management seek to promote this.

Suppliers, customers, and others:

The Board recognises that as a medical diagnostics Company, it is crucial that we deliver a reliable service to our customers and patients. The recent international political crisis around the world did not have any impact on the BED supply chain model. The Company does not have any customers or suppliers in Russia or Ukraine.

Our manufacturing partner in the USA enables a consistent supply of Axumin and POSLUMA products to the market. The Company has regular update meetings with our manufacturing partner to ensure the timely delivery of Axumin and POSLUMA doses to the customer. In addition, the strong and strategic relationship will be leveraged for the new product introductions.

Desirability of the company maintaining a reputation for high standards of business conduct

As a medical diagnostics Company, it is essential that we fully comply with regulations across a variety of territories. The Board regards compliance with the upmost importance and this message is delivered and followed by all facets of the business. Internal Audit and Compliance functions report to the Board on a regular basis and strong Whistleblowing policies have been adopted. Training and monitoring are continually developed and open communication between the Board and stakeholders is encouraged.

Community and environment:

Bracco’ s commitment to sustainability is continuously renewed and improved each year. In 2023, our Group was awarded a gold medal by Eco Vadis, one of the biggest sustainability rating platforms, receiving an overall score of 73/100. Furthermore, the Company has given greater form and substance to its vision and ambition through the Sustainability Plan. The plan has been framed in accordance with the UN’s 2030 Sustainable Development Goals (SDGs) and it contributes to 11 of the 17 goals by putting together different company departments to have a positive impact on people and the environment.

BLUE EARTH DIAGNOSTICS LIMITED
STRATEGIC REPORT (CONTINUED)
FOR THE YEAR ENDED 31 DECEMBER 2023
- 4 -

Within the social sphere of sustainability, the Company has obtained some meaningful results. In 2023, 49% of new hires were under the age of 30. Additionally, an increase of 21% of women in executive positions in Bracco S.p.A was registered since 2022, contributing to our ambitious target of reaching 45% by 2030. Finally, during the last year, we were able to reach and support over 11.400 Healthcare Professionals through educational activities and programs. By 2027, we aim to see this number increase up to 68.900.

 

Our environmental commitment is concretized through circular economy initiatives, the reduction of waste, and a decarbonization process in place. More specifically, we’ve achieved an iodine yield of over 83% and recovered 95% of organic solvents at our state-of-the-art plants. Regarding decarbonisation, our strategy includes actions to improve and maximise energy efficiency and to increase the use of renewable energy, reaching 40% of verified clean energy consumed by the group by 2025. Altogether, the system of actions in place is contributing to our goal of achieving 51% of scope 1 and 2 emissions reduction by 2030.

 

In terms of Governance, our sustainability commitment is demonstrated through our Human Rights Policy, delivered to 100% of our employees of which 87% executed the training. Additionally, in 2023, through our digital platform “Be Procurement” we qualified 100% of our suppliers, ensuring responsible choices across the value chain.

Finally, in order to assure a future-oriented and international approach to sustainability, Bracco Imaging has confirmed the United Nations Global Compact partnership, with the aim of developing, implementing and disclosing responsible business practices.

 

Furthermore, Blue Earth Diagnostics (BED) participates every year in the ATOM Festival of Science and Technology that takes place in Abingdon near Oxford, UK. It is a series of events for the local community, with the goal of engaging with young people and families and encouraging everyone to develop a passion for science and its potential to change the world. BED stall aimed to provide an understanding of what we do as a company. We wanted to explain how radioactivity is around us all the time and that it can be utilized in useful ways, such as in diagnostic medical imaging.

 

In 2023 BED also took part in the IF Oxford Science and Ideas Festival which is packed with inspiring, entertaining and immersive events for people of all ages. We took part with the goal of educating the attendees about radioactivity and how it can be used in medical imaging – in a fun and engaging way.

 

The Company also support a local school with a donation towards the STEM prizes.

On behalf of the board

Dr D E Gauden
Director
24 April 2024
BLUE EARTH DIAGNOSTICS LIMITED
DIRECTORS' REPORT
FOR THE YEAR ENDED 31 DECEMBER 2023
- 5 -

The directors present their annual report and financial statements for the year ended 31 December 2023.

Results and dividends

The results for the year are set out on page 11. The Company’s loss after taxation is $78,661,135 (2022: $12,594,297 loss). A business review is included in the strategic report.

 

The directors have not declared a dividend (2022: $20,000,000).

 

Directors

The directors who held office during the year and up to the date of signature of the financial statements were as follows:

Mr R Desimini
Mr C Y Petit
Mr F R Bracco
Mr F Tedoldi
Mr A Vismara
Dr D E Gauden

The main risks associated with the Company’s financial assets and liabilities are set out below:

 

Cash flow risk.

Certain transactions and assets are exposed to foreign currency risk. The company’s functional currently is USD and the majority of the sales and costs occur in USD. In the opinion of the directors, the risk associated with foreign currency movements is acceptable. The company doesn’t enter into financial instruments to hedge against foreign currency risk.

 

Credit risk

The company is exposed to credit risk on its accounts receivable and its cash balances. The credit risk on accounts receivable is managed through the comprehensive controls including enhanced credit check and monitoring customer credit limits on a continual basis to minimise bad debts and maintain control. The company’s cash balances are led with banks with high credit ratings assigned by international credit rating agencies.

 

Liquidity risk

Liquidity risk is the risk that the Company will encounter difficulty in meeting its obligations associated with its financial liabilities.

 

The Company finances its operations by a combination of retained profits and short-term intercompany credit arrangements to ensure there are sufficient liquid funds.

 

Management together with Bracco’s corporate treasury monitors rolling forecasts of the company’s liquidity reserve and cash and cash equivalents on the basis of expected cash flows. This is generally carried out at local level, in accordance with practice and limits set by the Bracco corporate group. In addition, the Bracco corporate liquidity management policy involves projecting cash flows in major currencies and considering the level of liquid assets necessary to meet these, monitoring balance sheet liquidity position.

Going concern

The Company’s business activities, together with the factors likely to affect its future development, performance and position are set out in the Strategic Report on pages. The financial position of the company, its cash position, liquidity osition can be seen in the balance sheet and accompanying notes to the financial statements.

 

Budgets and cash flow forecasts have been prepared and subsequently sensitised to take into account the current market situation. The directors have a reasonable expectation that the company has adequate resources to continue in operational existence for the foreseeable future. Accordingly, they continue to adopt the going concern basis in preparing the financial statements.

BLUE EARTH DIAGNOSTICS LIMITED
DIRECTORS' REPORT (CONTINUED)
FOR THE YEAR ENDED 31 DECEMBER 2023
- 6 -
Future developments

The Company’s performance is expected to continue throughout the next financial period, recovering market share following US Food and Drug Administration (FDA) approval and commercial launch of POSLUMA® (flotufolastat F 18).

 

The Company will continue the lifecycle management of flotufolastat (18F). The company plans to launch flotufolastat (18F) in Europe and through commercial partnerships, in other countries (for example, the development and commercialisation of flotufolastat (18F) in China in conjunction with Sinotau Pharmaceutical Group.

 

The Company will continue research into the use of 18F-fluciclovine in brain metastases, with a supplemental NDA (sNDA) expected in the near future.

 

The Company have worldwide rights to investigational Fibroblast Activation Protein (FAP)‐targeted imaging agents that are in early-stage development. These imaging agents have been shown to have the potential to improve lesion characterization in various cancer types. The Company will continue the development of the lead candidate FAP agent, completing a Phase 1 study in collaboration with an industry partner.

 

The Company will continue portfolio expansion activities for differentiated targeted molecular imaging agents.

 

Energy and carbon report

As the company has not consumed more than 40,000 kWh of energy in this reporting period, it qualifies as a low energy user under these regulations and is not required to report on its emissions, energy consumption or energy efficiency activities.

Statement of directors' responsibilities

The directors are responsible for preparing the annual report and the financial statements in accordance with applicable law and regulations.

 

Company law 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 United Kingdom Generally Accepted Accounting Practice (United Kingdom Accounting Standards and applicable law). Under company law the directors must not approve the financial statements unless they are satisfied that they give a true and fair view of the state of affairs of the company and of the profit or loss of the company for that period. In preparing these financial statements, the directors are required to:

 

 

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 company and enable them to ensure that the financial statements comply with the Companies Act 2006. They are also responsible for safeguarding the assets of the company and hence for taking reasonable steps for the prevention and detection of fraud and other irregularities.

Statement of disclosure to auditor

So far as each person who was a director at the date of approving this report is aware, there is no relevant audit information of which the company’s auditor is unaware. Additionally, the directors individually have taken all the necessary steps that they ought to have taken as directors in order to make themselves aware of all relevant audit information and to establish that the company’s auditor is aware of that information.

BLUE EARTH DIAGNOSTICS LIMITED
DIRECTORS' REPORT (CONTINUED)
FOR THE YEAR ENDED 31 DECEMBER 2023
- 7 -
On behalf of the board
Dr D E Gauden
Director
24 April 2024
BLUE EARTH DIAGNOSTICS LIMITED
INDEPENDENT AUDITOR'S REPORT
TO THE MEMBERS OF BLUE EARTH DIAGNOSTICS LIMITED
- 8 -
Opinion

We have audited the financial statements of Blue Earth Diagnostics Limited (the 'company') for the year ended 31 December 2023 which comprise the statement of comprehensive income, the balance sheet, the statement of changes in equity and notes to the financial statements, including significant accounting policies. The financial reporting framework that has been applied in their preparation is applicable law and United Kingdom Accounting Standards, including Financial Reporting Standard 102 The Financial Reporting Standard applicable in the UK and Republic of Ireland (United Kingdom Generally Accepted Accounting Practice).

In our opinion the financial statements:

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

Conclusions relating to going concern

In auditing the financial statements, we have concluded that the directors' use of the going concern basis of accounting in the preparation of the financial statements is appropriate.

 

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

 

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

Other information

The other information comprises the information included in the annual report other than the financial statements and our auditor's report thereon. The directors are responsible for the other information contained within the annual report. Our opinion on the financial statements does not cover the other information and, except to the extent otherwise explicitly stated in our report, we do not express any form of assurance conclusion thereon. Our responsibility is to read the other information and, in doing so, consider whether the other information is materially inconsistent with the financial statements or our knowledge obtained in the course of the audit, or otherwise appears to be materially misstated. If we identify such material inconsistencies or apparent material misstatements, we are required to determine whether this gives rise to a material misstatement in the financial statements themselves. If, based on the work we have performed, we conclude that there is a material misstatement of this other information, we are required to report that fact.

 

We have nothing to report in this regard.

Opinions on other matters prescribed by the Companies Act 2006

In our opinion, based on the work undertaken in the course of our audit:

BLUE EARTH DIAGNOSTICS LIMITED
INDEPENDENT AUDITOR'S REPORT (CONTINUED)
TO THE MEMBERS OF BLUE EARTH DIAGNOSTICS LIMITED
- 9 -
Matters on which we are required to report by exception

In the light of the knowledge and understanding of the company and its environment obtained in the course of the audit, we have not identified material misstatements in the strategic report or the directors' report.

 

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

Responsibilities of directors

As explained more fully in the directors' responsibilities statement, 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 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 company or to cease operations, or have no realistic alternative but to do so.

Auditor's responsibilities for the audit of the financial statements

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

A further description of our responsibilities is available on the Financial Reporting Council’s website at: https://www.frc.org.uk/auditorsresponsibilities. This description forms part of our auditor's report.

BLUE EARTH DIAGNOSTICS LIMITED
INDEPENDENT AUDITOR'S REPORT (CONTINUED)
TO THE MEMBERS OF BLUE EARTH DIAGNOSTICS LIMITED
- 10 -

Extent to which the audit was considered capable of detecting irregularities, including fraud

Irregularities, including fraud, are instances of non-compliance with laws and regulations. We design procedures in line with our responsibilities, outlined above and on the Financial Reporting Council’s website, to detect material misstatements in respect of irregularities, including fraud.

 

We obtain and update our understanding of the entity, its activities, its control environment, and likely future developments, including in relation to the legal and regulatory framework applicable and how the entity is complying with that framework.  Based on this understanding, we identify and assess the risks of material misstatement of the financial statements, whether due to fraud or error, design and perform audit procedures responsive to those risks, and obtain audit evidence that is sufficient and appropriate to provide a basis for our opinion.  This includes consideration of the risk of acts by the entity that were contrary to applicable laws and regulations, including fraud.

 

In response to the risk of irregularities and non-compliance with laws and regulations, including fraud, we designed procedures which included:

 

 

Because of the inherent limitations of an audit, there is a risk that we will not detect all irregularities, including those leading to a material misstatement in the financial statements or non-compliance with regulation.  This risk increases the more that compliance with a law or regulation is removed from the events and transactions reflected in the financial statements, as we will be less likely to become aware of instances of non-compliance.  The risk of not detecting a material misstatement resulting from fraud is higher than for one resulting from error, as fraud may involve collusion, forgery, intentional omissions, misrepresentations, or the override of internal control.

Use of our report

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

David Green MA (Cantab) FCA (Senior Statutory Auditor)
For and on behalf of Azets Audit Services
30 April 2024
Chartered Accountants
Statutory Auditor
Suites B & D
Burnham Yard
London End
Beaconsfield
Buckinghamshire
United Kingdom
HP9 2JH
BLUE EARTH DIAGNOSTICS LIMITED
STATEMENT OF COMPREHENSIVE INCOME
FOR THE YEAR ENDED 31 DECEMBER 2023
- 11 -
2023
2022
Notes
$
$
Turnover
3
14,131,687
91,432,176
Cost of sales
(22,809,389)
(37,229,374)
Gross (loss)/profit
(8,677,702)
54,202,802
Research and development expenses
(19,496,432)
(25,252,451)
Administrative expenses
(25,970,130)
(14,615,248)
Sales and marketing expenses
(29,582,326)
(30,025,520)
Other operating income
4,510,858
2,294,200
Operating loss
5
(79,215,732)
(13,396,217)
Interest receivable and similar income
9
554,597
471,575
Loss before taxation
(78,661,135)
(12,924,642)
Tax on loss
10
109,791
330,345
Loss for the financial year
(78,551,344)
(12,594,297)

The profit and loss account has been prepared on the basis that all operations are continuing operations.

BLUE EARTH DIAGNOSTICS LIMITED
BALANCE SHEET
AS AT 31 DECEMBER 2023
31 December 2023
- 12 -
2023
2022
Notes
$
$
$
$
Fixed assets
Intangible assets
12
19,613,815
22,483,114
Tangible assets
13
59,376
178,883
Investments
14
568
568
19,673,759
22,662,565
Current assets
Stocks
16
1,288,372
1,803,170
Debtors
17
6,016,517
8,981,676
Cash at bank and in hand
5,615,770
76,325,156
12,920,659
87,110,002
Creditors: amounts falling due within one year
18
(15,135,738)
(19,681,387)
Net current (liabilities)/assets
(2,215,079)
67,428,615
Total assets less current liabilities
17,458,680
90,091,180
Creditors: amounts falling due after more than one year
19
(880,905)
(889,944)
Provisions for liabilities
Provisions
20
6,000,000
-
0
Deferred tax liability
-
0
72,117
(6,000,000)
(72,117)
Net assets
10,577,775
89,129,119
Capital and reserves
Called up share capital
22
29,210,175
29,210,175
Share premium account
1,222,012
1,222,012
Profit and loss reserves
(19,854,412)
58,696,932
Total equity
10,577,775
89,129,119
The financial statements were approved by the board of directors and authorised for issue on 24 April 2024 and are signed on its behalf by:
Dr D E Gauden
Director
Company Registration No. 08773116
BLUE EARTH DIAGNOSTICS LIMITED
STATEMENT OF CHANGES IN EQUITY
FOR THE YEAR ENDED 31 DECEMBER 2023
- 13 -
Share capital
Share premium account
Profit and loss reserves
Total
Notes
$
$
$
$
Balance at 1 January 2022
29,210,175
1,222,012
91,291,229
121,723,416
Year ended 31 December 2022:
Loss and total comprehensive income for the year
-
-
(12,594,297)
(12,594,297)
Dividends
11
-
-
(20,000,000)
(20,000,000)
Balance at 31 December 2022
29,210,175
1,222,012
58,696,932
89,129,119
Year ended 31 December 2023:
Loss and total comprehensive income for the year
-
-
(78,551,344)
(78,551,344)
Balance at 31 December 2023
29,210,175
1,222,012
(19,854,412)
10,577,775
BLUE EARTH DIAGNOSTICS LIMITED
NOTES TO THE FINANCIAL STATEMENTS
FOR THE YEAR ENDED 31 DECEMBER 2023
- 14 -
1
Accounting policies
Company information

Blue Earth Diagnostics Limited is a private company limited by shares incorporated in England and Wales. The registered office is Magdalen Centre, The Oxford Science Park, Oxford, Oxfordshire, UK, OX4 4GA.

1.1
Accounting convention

These financial statements have been prepared in accordance with FRS 102 “The Financial Reporting Standard applicable in the UK and Republic of Ireland” (“FRS 102”) and the requirements of the Companies Act 2006.

The financial statements are prepared in sterling, which is the functional currency of the company. Monetary amounts in these financial statements are rounded to the nearest $.

The financial statements have been prepared under the historical cost convention. The principal accounting policies adopted are set out below.

This company is a qualifying entity for the purposes of FRS 102, being a member of a group where the parent of that group prepares publicly available consolidated financial statements, including this company, which are intended to give a true and fair view of the assets, liabilities, financial position and profit or loss of the group. The company has therefore taken advantage of exemptions from the following disclosure requirements:

 

 

The financial statements of the company are consolidated in the financial statements of Bracco s.p.A.. These consolidated financial statements are available at the Business Register of the Chamber of Commerce of Milan, Monza, Brianza, Lodi, Italy.

1.2
Going concern

Atruet the time of approving the financial statements, the directors have a reasonable expectation that the company has adequate resources to continue in operational existence for the foreseeable future. Thus the directors continue to adopt the going concern basis of accounting in preparing the financial statements.

1.3
Turnover

Turnover is recognised at the fair value of the consideration received or receivable for goods and services provided in the normal course of business, and is shown net of VAT and other sales related taxes. The fair value of consideration takes into account trade discounts, settlement discounts and volume rebates.

 

When cash inflows are deferred and represent a financing arrangement, the fair value of the consideration is the present value of the future receipts. The difference between the fair value of the consideration and the nominal amount received is recognised as interest income.

Revenue from the sale of goods is recognised when the significant risks and rewards of ownership of the goods have passed to the buyer (usually on dispatch of the goods), the amount of revenue can be measured reliably, it is probable that the economic benefits associated with the transaction will flow to the entity and the costs incurred or to be incurred in respect of the transaction can be measured reliably.

BLUE EARTH DIAGNOSTICS LIMITED
NOTES TO THE FINANCIAL STATEMENTS (CONTINUED)
FOR THE YEAR ENDED 31 DECEMBER 2023
1
Accounting policies
(Continued)
- 15 -

Revenue from contracts for the provision of professional services is recognised by reference to the stage of completion when the stage of completion, costs incurred and costs to complete can be estimated reliably. The stage of completion is calculated by comparing costs incurred, mainly in relation to contractual hourly staff rates and materials, as a proportion of total costs. Where the outcome cannot be estimated reliably, revenue is recognised only to the extent of the expenses recognised that it is probable will be recovered.

Revenue from license fees is recognised based on the milestones achieved per the agreement contract.

1.4
Research and development expenditure

Research expenditure is written off against profits in the year in which it is incurred. Identifiable development expenditure is capitalised to the extent that the technical, commercial and financial feasibility can be demonstrated.

1.5
Intangible fixed assets other than goodwill

Intangible assets acquired separately from a business are recognised at cost and are subsequently measured at cost less accumulated amortisation and accumulated impairment losses.

 

Intangible assets acquired on business combinations are recognised separately from goodwill at the acquisition date where it is probable that the expected future economic benefits that are attributable to the asset will flow to the entity and the fair value of the asset can be measured reliably; the intangible asset arises from contractual or other legal rights; and the intangible asset is separable from the entity.

Amortisation is recognised so as to write off the cost or valuation of assets less their residual values over their useful lives on the following bases:

Patents & licences
10 - 20 years
1.6
Tangible fixed assets

Tangible fixed assets are initially measured at cost and subsequently measured at cost or valuation, net of depreciation and any impairment losses.

Depreciation is recognised so as to write off the cost or valuation of assets less their residual values over their useful lives on the following bases:

Leasehold improvements
3 years
Fixtures and fittings
3 years
Computers
3 years

The gain or loss arising on the disposal of an asset is determined as the difference between the sale proceeds and the carrying value of the asset, and is credited or charged to profit or loss.

1.7
Fixed asset investments

Interests in subsidiaries, associates and jointly controlled entities are initially measured at cost and subsequently measured at cost less any accumulated impairment losses. The investments are assessed for impairment at each reporting date and any impairment losses or reversals of impairment losses are recognised immediately in profit or loss.

A subsidiary is an entity controlled by the company. Control is the power to govern the financial and operating policies of the entity so as to obtain benefits from its activities.

BLUE EARTH DIAGNOSTICS LIMITED
NOTES TO THE FINANCIAL STATEMENTS (CONTINUED)
FOR THE YEAR ENDED 31 DECEMBER 2023
1
Accounting policies
(Continued)
- 16 -

An associate is an entity, being neither a subsidiary nor a joint venture, in which the company holds a long-term interest and where the company has significant influence. The company considers that it has significant influence where it has the power to participate in the financial and operating decisions of the associate.

Entities in which the company has a long term interest and shares control under a contractual arrangement are classified as jointly controlled entities.

1.8
Impairment of fixed assets

At each reporting period end date, the company reviews the carrying amounts of its tangible and intangible assets to determine whether there is any indication that those assets have suffered an impairment loss. If any such indication exists, the recoverable amount of the asset is estimated in order to determine the extent of the impairment loss (if any). Where it is not possible to estimate the recoverable amount of an individual asset, the company estimates the recoverable amount of the cash-generating unit to which the asset belongs.

Recoverable amount is the higher of fair value less costs to sell and value in use. In assessing value in use, the estimated future cash flows are discounted to their present value using a pre-tax discount rate that reflects current market assessments of the time value of money and the risks specific to the asset for which the estimates of future cash flows have not been adjusted.

 

If the recoverable amount of an asset (or cash-generating unit) is estimated to be less than its carrying amount, the carrying amount of the asset (or cash-generating unit) is reduced to its recoverable amount. An impairment loss is recognised immediately in profit or loss, unless the relevant asset is carried at a revalued amount, in which case the impairment loss is treated as a revaluation decrease.

Recognised impairment losses are reversed if, and only if, the reasons for the impairment loss have ceased to apply. Where an impairment loss subsequently reverses, the carrying amount of the asset (or cash-generating unit) is increased to the revised estimate of its recoverable amount, but so that the increased carrying amount does not exceed the carrying amount that would have been determined had no impairment loss been recognised for the asset (or cash-generating unit) in prior years. A reversal of an impairment loss is recognised immediately in profit or loss, unless the relevant asset is carried at a revalued amount, in which case the reversal of the impairment loss is treated as a revaluation increase.

1.9
Stocks

Stocks are stated at the lower of cost and estimated selling price less costs to complete and sell. Cost comprises direct materials and, where applicable, direct labour costs and those overheads that have been incurred in bringing the stocks to their present location and condition.

 

Stocks held for distribution at no or nominal consideration are measured at the lower of cost and replacement cost, adjusted where applicable for any loss of service potential.

At each reporting date, an assessment is made for impairment. Any excess of the carrying amount of stocks over its estimated selling price less costs to complete and sell is recognised as an impairment loss in profit or loss. Reversals of impairment losses are also recognised in profit or loss.

1.10
Cash and cash equivalents

Cash and cash equivalents are basic financial assets and include cash in hand, deposits held at call with banks, other short-term liquid investments with original maturities of three months or less, and bank overdrafts. Bank overdrafts are shown within borrowings in current liabilities.

BLUE EARTH DIAGNOSTICS LIMITED
NOTES TO THE FINANCIAL STATEMENTS (CONTINUED)
FOR THE YEAR ENDED 31 DECEMBER 2023
1
Accounting policies
(Continued)
- 17 -
1.11
Financial instruments

The company has elected to apply the provisions of Section 11 ‘Basic Financial Instruments’ and Section 12 ‘Other Financial Instruments Issues’ of FRS 102 to all of its financial instruments.

 

Financial instruments are recognised in the company's balance sheet when the company becomes party to the contractual provisions of the instrument.

 

Financial assets and liabilities are offset, with the net amounts presented in the financial statements, when there is a legally enforceable right to set off the recognised amounts and there is an intention to settle on a net basis or to realise the asset and settle the liability simultaneously.

Basic financial assets

Basic financial assets, which include debtors and cash and bank balances, are initially measured at transaction price including transaction costs and are subsequently carried at amortised cost using the effective interest method unless the arrangement constitutes a financing transaction, where the transaction is measured at the present value of the future receipts discounted at a market rate of interest. Financial assets classified as receivable within one year are not amortised.

Other financial assets

Other financial assets, including investments in equity instruments which are not subsidiaries, associates or joint ventures, are initially measured at fair value, which is normally the transaction price. Such assets are subsequently carried at fair value and the changes in fair value are recognised in profit or loss, except that investments in equity instruments that are not publicly traded and whose fair values cannot be measured reliably are measured at cost less impairment.

Impairment of financial assets

Financial assets, other than those held at fair value through profit and loss, are assessed for indicators of impairment at each reporting end date.

 

Financial assets are impaired where there is objective evidence that, as a result of one or more events that occurred after the initial recognition of the financial asset, the estimated future cash flows have been affected. If an asset is impaired, the impairment loss is the difference between the carrying amount and the present value of the estimated cash flows discounted at the asset’s original effective interest rate. The impairment loss is recognised in profit or loss.

 

If there is a decrease in the impairment loss arising from an event occurring after the impairment was recognised, the impairment is reversed. The reversal is such that the current carrying amount does not exceed what the carrying amount would have been, had the impairment not previously been recognised. The impairment reversal is recognised in profit or loss.

Derecognition of financial assets

Financial assets are derecognised only when the contractual rights to the cash flows from the asset expire or are settled, or when the company transfers the financial asset and substantially all the risks and rewards of ownership to another entity, or if some significant risks and rewards of ownership are retained but control of the asset has transferred to another party that is able to sell the asset in its entirety to an unrelated third party.

Classification of financial liabilities

Financial liabilities and equity instruments are classified according to the substance of the contractual arrangements entered into. An equity instrument is any contract that evidences a residual interest in the assets of the company after deducting all of its liabilities.

BLUE EARTH DIAGNOSTICS LIMITED
NOTES TO THE FINANCIAL STATEMENTS (CONTINUED)
FOR THE YEAR ENDED 31 DECEMBER 2023
1
Accounting policies
(Continued)
- 18 -
Basic financial liabilities

Basic financial liabilities, including creditors, bank loans, loans from fellow group companies and preference shares that are classified as debt, are initially recognised at transaction price unless the arrangement constitutes a financing transaction, where the debt instrument is measured at the present value of the future payments discounted at a market rate of interest. Financial liabilities classified as payable within one year are not amortised.

 

Debt instruments are subsequently carried at amortised cost, using the effective interest rate method.

 

Trade creditors are obligations to pay for goods or services that have been acquired in the ordinary course of business from suppliers. Amounts payable are classified as current liabilities if payment is due within one year or less. If not, they are presented as non-current liabilities. Trade creditors are recognised initially at transaction price and subsequently measured at amortised cost using the effective interest method.

Other financial liabilities

Derivatives, including interest rate swaps and forward foreign exchange contracts, are not basic financial instruments. Derivatives are initially recognised at fair value on the date a derivative contract is entered into and are subsequently re-measured at their fair value. Changes in the fair value of derivatives are recognised in profit or loss in finance costs or finance income as appropriate, unless hedge accounting is applied and the hedge is a cash flow hedge.

 

Debt instruments that do not meet the conditions in FRS 102 paragraph 11.9 are subsequently measured at fair value through profit or loss. Debt instruments may be designated as being measured at fair value through profit or loss to eliminate or reduce an accounting mismatch or if the instruments are measured and their performance evaluated on a fair value basis in accordance with a documented risk management or investment strategy.

Derecognition of financial liabilities

Financial liabilities are derecognised when the company’s contractual obligations expire or are discharged or cancelled.

1.12
Equity instruments

Equity instruments issued by the company are recorded at the proceeds received, net of transaction costs. Dividends payable on equity instruments are recognised as liabilities once they are no longer at the discretion of the company.

1.13
Taxation

The tax expense represents the sum of the tax currently payable and deferred tax.

Current tax

The tax currently payable is based on taxable profit for the year. Taxable profit differs from net profit as reported in the profit and loss account because it excludes items of income or expense that are taxable or deductible in other years and it further excludes items that are never taxable or deductible. The company’s liability for current tax is calculated using tax rates that have been enacted or substantively enacted by the reporting end date.

BLUE EARTH DIAGNOSTICS LIMITED
NOTES TO THE FINANCIAL STATEMENTS (CONTINUED)
FOR THE YEAR ENDED 31 DECEMBER 2023
1
Accounting policies
(Continued)
- 19 -
Deferred tax

Deferred tax liabilities are generally recognised for all timing differences and deferred tax assets are recognised to the extent that it is probable that they will be recovered against the reversal of deferred tax liabilities or other future taxable profits. Such assets and liabilities are not recognised if the timing difference arises from goodwill or from the initial recognition of other assets and liabilities in a transaction that affects neither the tax profit nor the accounting profit.

 

The carrying amount of deferred tax assets is reviewed at each reporting end date and reduced to the extent that it is no longer probable that sufficient taxable profits will be available to allow all or part of the asset to be recovered. Deferred tax is calculated at the tax rates that are expected to apply in the period when the liability is settled or the asset is realised. Deferred tax is charged or credited in the profit and loss account, except when it relates to items charged or credited directly to equity, in which case the deferred tax is also dealt with in equity. Deferred tax assets and liabilities are offset when the company has a legally enforceable right to offset current tax assets and liabilities and the deferred tax assets and liabilities relate to taxes levied by the same tax authority.

1.14
Provisions

Provisions are recognised when the company has a legal or constructive present obligation as a result of a past event, it is probable that the company will be required to settle that obligation and a reliable estimate can be made of the amount of the obligation.

 

The amount recognised as a provision is the best estimate of the consideration required to settle the present obligation at the reporting end date, taking into account the risks and uncertainties surrounding the obligation. Where the effect of the time value of money is material, the amount expected to be required to settle the obligation is recognised at present value. When a provision is measured at present value, the unwinding of the discount is recognised as a finance cost in profit or loss in the period in which it arises.

1.15
Employee benefits

The costs of short-term employee benefits are recognised as a liability and an expense, unless those costs are required to be recognised as part of the cost of stock or fixed assets.

 

The cost of any unused holiday entitlement is recognised in the period in which the employee’s services are received.

 

Termination benefits are recognised immediately as an expense when the company is demonstrably committed to terminate the employment of an employee or to provide termination benefits.

1.16
Retirement benefits

Payments to defined contribution retirement benefit schemes are charged as an expense as they fall due.

1.17
Leases

Rentals payable under operating leases, including any lease incentives received, are charged to profit or loss on a straight line basis over the term of the relevant lease except where another more systematic basis is more representative of the time pattern in which economic benefits from the leases asset are consumed.

BLUE EARTH DIAGNOSTICS LIMITED
NOTES TO THE FINANCIAL STATEMENTS (CONTINUED)
FOR THE YEAR ENDED 31 DECEMBER 2023
- 20 -
2
Judgements and key sources of estimation uncertainty

In the application of the company’s accounting policies, the directors are required to make judgements, estimates and assumptions about the carrying amount of assets and liabilities that are not readily apparent from other sources. The estimates and associated assumptions are based on historical experience and other factors that are considered to be relevant. Actual results may differ from these estimates.

 

The estimates and underlying assumptions are reviewed on an ongoing basis. Revisions to accounting estimates are recognised in the period in which the estimate is revised where the revision affects only that period, or in the period of the revision and future periods where the revision affects both current and future periods.

3
Turnover and other revenue
2023
2022
$
$
Turnover analysed by class of business
Sale of Axumin
11,694,828
91,432,176
Sale of Posluma
2,436,859
-
14,131,687
91,432,176
2023
2022
$
$
Turnover analysed by geographical market
Europe
1,145,792
872,532
United States of America
12,985,895
90,559,644
14,131,687
91,432,176
2023
2022
$
$
Other revenue
Interest income
554,597
471,575
4
Exceptional items
2023
2022
$
$
Expenditure
Exceptional item - Provision for customer rebate program
6,000,000
-
Exceptional item - Intangibles impairment
4,900,000
3,000,000
10,900,000
3,000,000

Refer to note 20 for detail on the provision for customer rebates program. Refer to note 12 for detail on the intangibles impairment.

BLUE EARTH DIAGNOSTICS LIMITED
NOTES TO THE FINANCIAL STATEMENTS (CONTINUED)
FOR THE YEAR ENDED 31 DECEMBER 2023
- 21 -
5
Operating loss
2023
2022
Operating loss for the year is stated after charging/(crediting):
$
$
Exchange losses/(gains)
677,225
(438,820)
Research and development costs
46,468,031
56,152,219
Depreciation of owned tangible fixed assets
119,507
181,458
Amortisation of intangible assets
693,049
534,164
Impairment of intangible assets
4,900,000
3,000,000
Operating lease charges
620,760
553,550
6
Auditor's remuneration
2023
2022
Fees payable to the company's auditor and associates:
$
$
For audit services
Audit of the financial statements of the company
98,124
89,722
For other services
Taxation compliance services
11,744
6,029
All other non-audit services
4,010
5,426
15,754
11,455

 

7
Employees

The average monthly number of persons (including directors) employed by the company during the year was:

2023
2022
Number
Number
Research and development
18
15
Medical Affairs
4
3
Regulatory
5
4
Sales and Marketing
5
7
General and Administration
18
15
Total
50
44
BLUE EARTH DIAGNOSTICS LIMITED
NOTES TO THE FINANCIAL STATEMENTS (CONTINUED)
FOR THE YEAR ENDED 31 DECEMBER 2023
7
Employees
(Continued)
- 22 -

Their aggregate remuneration comprised:

2023
2022
$
$
Wages and salaries
6,701,949
1,157,973
Social security costs
842,819
875,352
Pension costs
543,654
475,446
8,088,422
2,508,771
8
Directors' remuneration
2023
2022
$
$
Remuneration for qualifying services
321,964
290,901
Company pension contributions to defined contribution schemes
28,845
26,145
350,809
317,046
Remuneration disclosed above include the following amounts paid to the highest paid director:
2023
2022
$
$
Remuneration for qualifying services
291,964
273,833
Company pension contributions to defined contribution schemes
26,145
24,645

There were 2 (2022: 2) paid directors during the year. The remuneration for the highest paid director was as above.

9
Interest receivable and similar income
2023
2022
$
$
Interest income
Interest on bank deposits
851,674
471,575

Bank interest receivable includes $847k (2022: $466k) from a cash pooling program managed by Bracco Imaging s.p.A.

BLUE EARTH DIAGNOSTICS LIMITED
NOTES TO THE FINANCIAL STATEMENTS (CONTINUED)
FOR THE YEAR ENDED 31 DECEMBER 2023
- 23 -
10
Taxation
2023
2022
$
$
Current tax
UK corporation tax on profits for the current period
-
0
(533,433)
Adjustments in respect of prior periods
(109,791)
203,088
Total current tax
(109,791)
(330,345)

The actual credit for the year can be reconciled to the expected credit for the year based on the profit or loss and the standard rate of tax as follows:

2023
2022
$
$
Loss before taxation
(78,661,135)
(12,924,642)
Expected tax credit based on the standard rate of corporation tax in the UK of 25.00% (2022: 19.00%)
(19,665,284)
(2,455,682)
Tax effect of expenses that are not deductible in determining taxable profit
1,483,961
1,824
Tax effect of income not taxable in determining taxable profit
(386,655)
(938,097)
Unutilised tax losses carried forward
18,567,978
5,283,531
Change in unrecognised deferred tax assets
-
0
(7,558)
Adjustments in respect of prior years
(109,791)
203,088
Deferred tax adjustments in respect of prior years
-
0
(1,266,233)
Deductions for patent box
-
0
(771,340)
RDEC Credit Claimed
-
0
(377,094)
Fixed asset differences
-
0
(2,784)
Taxation credit for the year
(109,791)
(330,345)
11
Dividends
2023
2022
$
$
Final paid
-
0
20,000,000
BLUE EARTH DIAGNOSTICS LIMITED
NOTES TO THE FINANCIAL STATEMENTS (CONTINUED)
FOR THE YEAR ENDED 31 DECEMBER 2023
- 24 -
12
Intangible fixed assets
Patents & licences
$
Cost
At 1 January 2023
28,268,719
Additions
2,723,750
At 31 December 2023
30,992,469
Amortisation and impairment
At 1 January 2023
5,785,605
Amortisation charged for the year
693,049
Impairment losses
4,900,000
At 31 December 2023
11,378,654
Carrying amount
At 31 December 2023
19,613,815
At 31 December 2022
22,483,114

Intangible assets have been impaired to reflect the carrying value of the assets.

The balance of intangible assets comprises the purchase of a number of diagnostic technology licenses for development and commercialisation.

13
Tangible fixed assets
Leasehold improvements
Fixtures and fittings
Computers
Total
$
$
$
$
Cost
At 1 January 2023 and 31 December 2023
227,350
109,030
412,821
749,201
Depreciation and impairment
At 1 January 2023
162,451
87,345
320,522
570,318
Depreciation charged in the year
43,853
15,248
60,406
119,507
At 31 December 2023
206,304
102,593
380,928
689,825
Carrying amount
At 31 December 2023
21,046
6,437
31,893
59,376
At 31 December 2022
64,899
21,685
92,299
178,883
BLUE EARTH DIAGNOSTICS LIMITED
NOTES TO THE FINANCIAL STATEMENTS (CONTINUED)
FOR THE YEAR ENDED 31 DECEMBER 2023
- 25 -
14
Fixed asset investments
2023
2022
Notes
$
$
Investments in subsidiaries
15
568
568
15
Subsidiaries

Details of the company's subsidiaries at 31 December 2023 are as follows:

Name of undertaking
Registered office
Class of
% Held
shares held
Direct
Blue Earth Diagnostics Inc.
United States of America
Ordinary
100.00
Blue Earth Diagnostics Ireland Limited
Ireland
Ordinary
100.00

Blue Earth Diagnostics Inc. registered address is at 25 Burlington Mall Road, Suite 206, Burlington, MA 01803, United States of America and Blue Earth Ireland Limited is at 6th Floor, 2 Grand Canal Square, Dublin 2, Ireland.

16
Stocks
2023
2022
$
$
Raw materials and consumables
1,288,372
1,803,170

Raw materials recognised as cost of sales in the period amounted to $324,577 (2022: $826,326).

The write down of stocks to net realisable value amounted to $896,594 (2022: $59,393).

17
Debtors
2023
2022
Amounts falling due within one year:
$
$
Trade debtors
2,423,218
5,425,856
Amounts owed by group undertakings
2,331,268
2,227,593
Other debtors
165,944
690,312
Prepayments and accrued income
1,168,204
637,915
6,088,634
8,981,676
2023
2022
Amounts falling due after more than one year:
$
$
Deferred tax asset (note )
(72,117)
-
0
Total debtors
6,016,517
8,981,676
BLUE EARTH DIAGNOSTICS LIMITED
NOTES TO THE FINANCIAL STATEMENTS (CONTINUED)
FOR THE YEAR ENDED 31 DECEMBER 2023
17
Debtors
(Continued)
- 26 -

Amounts owed by group undertakings comprise of intercompany balances that are unsecured, interest free and repayable on demand.

 

18
Creditors: amounts falling due within one year
2023
2022
$
$
Trade creditors
8,635,971
7,919,723
Amounts owed to group undertakings
3,945,742
4,074,514
Corporation tax
(936,273)
(1,730,328)
Other taxation and social security
-
0
32,545
Other creditors
256,100
967,734
Accruals and deferred income
3,234,198
8,417,199
15,135,738
19,681,387

Amounts owed to group undertakings comprise of intercompany balances that are unsecured, interest free and repayable on demand.

 

19
Creditors: amounts falling due after more than one year
2023
2022
$
$
Accruals and deferred income
880,905
889,944

Long term benefit plan relates to a management incentive programme implemented following the acquisition of the company by Bracco Imaging S.p.A on 31 July 2019.

20
Provisions for liabilities
2023
2022
$
$
Provision for customer rebate program
6,000,000
-
Movements on provisions:
Provision for customer rebate program
$
Additional provisions in the year
6,000,000
BLUE EARTH DIAGNOSTICS LIMITED
NOTES TO THE FINANCIAL STATEMENTS (CONTINUED)
FOR THE YEAR ENDED 31 DECEMBER 2023
20
Provisions for liabilities
(Continued)
- 27 -

This nature of the provision is that of the potential costs to customers as part of a rebate program from the sales of Axumin. This is expected to be settled within one year with a best estimate of $6,000,000.

21
Retirement benefit schemes
2023
2022
Defined contribution schemes
$
$
Charge to profit or loss in respect of defined contribution schemes
543,654
475,446

The company operates a defined contribution pension scheme for all qualifying employees. The assets of the scheme are held separately from those of the company in an independently administered fund. The unpaid contributions outstanding at the year-end were $87,408 (2022: $66,043).

 

The total expense relating to these plans in the current year was $543,654 (2022: $475,446).

 

22
Share capital
2023
2022
2023
2022
Ordinary share capital
Number
Number
$
$
Authorised
$000
$000
Issued and fully paid
Ordinary shares of 0.001p each
24,000,563
24,000,563
29,210,175
29,210,175

During the year the company paid a dividend of $Nil (2022: $20,000,000).

23
Operating lease commitments
Lessee

At the reporting end date the company had outstanding commitments for future minimum lease payments under non-cancellable operating leases, which fall due as follows:

2023
2022
$
$
Within one year
267,903
557,308
Between two and five years
-
0
200,020
267,903
757,328

During the period $620,760 (2022: $553,225) was recognised as an expense in the profit and loss account in respect of operating lease expense.

BLUE EARTH DIAGNOSTICS LIMITED
NOTES TO THE FINANCIAL STATEMENTS (CONTINUED)
FOR THE YEAR ENDED 31 DECEMBER 2023
- 28 -
24
Ultimate controlling party

The smallest and largest group in which the results of the company are consolidated is that headed by Bracco s.p.A, the accounts of which are available at Business Register of the Chamber of Commerce of Milan, Monza, Brianza, Lodi, Italy. Bracco s.p.A is the ultimate holding company, controlling party and is incorporated and registered in Italy. Its registered office address is Via Egidio Folli 50, 20134 Milan, Italy.

 

Bracco Horizons Limited is the immediate parent company of Blue Earth Diagnostics Limited and is incorporated in Great Britain and is registered in England.

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