Company registration number 08773116 (England and Wales)
BLUE EARTH DIAGNOSTICS LIMITED
ANNUAL REPORT AND FINANCIAL STATEMENTS
FOR THE YEAR ENDED 31 DECEMBER 2024
BLUE EARTH DIAGNOSTICS LIMITED
COMPANY INFORMATION
Directors
Mr R Desimini
Mr C Y Petit
Mr F R Bracco
Mr F Tedoldi
Mr M Campione
(Appointed 30 June 2024)
Secretary
Ms R Mowat
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 - 6
Directors' responsibilities statement
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 2024
- 1 -
The directors present the strategic report for the year ended 31 December 2024.
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 18F) 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 37 manufacturing sites in the US through a single manufacturing and distribution partner, with plans to expand to alternate manufacturers in 2025 for both commercial and self-manufacture.
Axumin® (fluciclovine 18F) is still manufactured in the US, three European countries 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 have spread from other primary tumours.
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 characterisation in various cancer types. The Company will continue portfolio expansion activities for differentiated targeted molecular imaging agents.
Fair review of the business
In 2024, the company continued to face competitive headwinds from in market PSMA (Prostate Specific Membrane Antigen) products, notably Pylarify® from Lantheus and Illuccix® from Telix. Axumin® (fluciclovine F 18) injection sales continued to decline in the US, reaching a low point in Q4 2024. POSLUMA® (flotufolastat F 18) injection, formerly referred to as rhPSMA-7.3, was approved on May 26, 2023. POSLUMA received its Healthcare Common Procedure Coding System (HCPCS) product specific reimbursement code in January 2024, which helped drive sales during 2024 with increased sales in the later part of the year as POSLUMA will be the only 18F labelled PSMA on market with Transitional Pass-Through from January 2025. The company has been working with industry groups to achieve separate payment from the Centres for Medicare & Medicaid Services (CMS) for diagnostic radiopharmaceuticals in the hospital setting and in July 2024 CMS announced a change to the payment methodology. While positive, this change caused some confusion with hospitals and US sales of POSLUMA did not grow as anticipated in Q4 2024; the company now anticipates this growth in early 2025. In January 2024, following a extensive review of the company’s go-to-market strategy, the company realigned field teams to better coordinate internally and better serve our customers in the field. This alignment immediately improved our communications and collaboration among the field teams.
BLUE EARTH DIAGNOSTICS LIMITED
STRATEGIC REPORT (CONTINUED)
FOR THE YEAR ENDED 31 DECEMBER 2024
- 2 -
During 2024 the company continued to support the expansion of 18F-flotufolastat into key international growth markets. Our international partners all made progress in 2024, with Markey Authorisation applications being submitted in Taiwan (via Global Medical Solutions) Turkey (via Medicheck) and Korea (via DuChemBio). It is expected that the Market Authorisation for 18F-flotufolastat in these markets will be granted during 2025.
During 2024, the company has continued to heavily invest in R&D, despite the spending slightly decreasing to $16.8m vs. $19.5m in 2023.
Approximately 17 individuals in the US (predominantly Medical Affairs support) and 25 in Europe are employed on R&D-focused activities encompassing chemistry development, pre-clinical and clinical research.
The company received approval for its prostate cancer agent, POSLUMA® (flotufolastat 18F), from the US Food and Drug Administration (FDA) in 2023. Lifecycle management of POSLUMA in 2024 included the initiation of a Phase 4 clinical study (NCT06604442). This study has been designed as an intra-patient study directly comparing urinary radioactivity for flotufolastat (18F) to another FDA approved 18F labelled radiopharmaceutical for PSMA PET (piflufolastat (18F)) in men with low PSA biochemical recurrence of prostate cancer following radical prostatectomy.
During 2024, 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, in collaboration with an industry partner investigating the safety and efficacy of the lead candidate FAP agent, continued enrolment.
Key performance indicators
The most relevant indicators for the business for 2024 were:
Turnover increased by $57.1m (2024 revenue $71.2m vs 2023 revenue $14.1m)
Gross profit increased by $39.9m (2024 gross profit $31.2m vs 2023 gross loss of $8.7m)
The reason for increase is due to more customers signing up for Posluma in USA.
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;
BLUE EARTH DIAGNOSTICS LIMITED
STRATEGIC REPORT (CONTINUED)
FOR THE YEAR ENDED 31 DECEMBER 2024
- 3 -
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.
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.
BLUE EARTH DIAGNOSTICS LIMITED
STRATEGIC REPORT (CONTINUED)
FOR THE YEAR ENDED 31 DECEMBER 2024
- 4 -
Community and environment:
Bracco’s commitment to sustainability is continuously strengthened and enhanced each year. In 2024, our group once again received the Gold Medal from EcoVadis, one of the world's leading sustainability rating platforms, achieving an overall score of 79/100 and ranking among the top 5% of companies in ESG performance.
Furthermore, the company has reinforced its vision and ambition through the Sustainability Plan, which has been updated to reflect the latest developments and 2024 KPIs across the three ESG dimensions. This plan ensures continuous monitoring of achieved results and progress toward the 2030 objectives, aligned with the United Nations' Sustainable Development Goals (SDGs).
Within the social aspects of sustainability, we have achieved notable results. In 2024, 27% of new hires were under the age of 30. Additionally, during the last year, up to over 13,000 Healthcare Professionals were reached and supported through educational activities and programs, resulting in a total of 42,900 people involved since the target was set. Finally, in the area of pharmacovigilance, a 99% response rate within 24 hours was maintained by the scientific team.
Our environmental efforts are demonstrated through circular economy initiatives, waste reduction, and a decarbonization process. Specifically, our plants have achieved an iodine yield of over 83% and recovered over 96% of organic solvents. Our decarbonisation strategy includes actions to improve and maximise energy efficiency and increase the use of renewable energy, and we achieved an increase in purchased renewable electricity by 50% compared to 2023. These measures contribute to our goal of achieving a 51% reduction in scope 1 and 2 emissions by 2030.
In terms of governance, our commitment to sustainability is shown through ongoing training on Business Conduct and Ethics. As of 2024, 2,219 employees have received training on anti-corruption and anti-trust. Additionally, in 2024, we qualified 100% of our suppliers through our digital platform "Be Procurement," ensuring responsible choices across the value chain. As an initial pilot project, we conducted a comprehensive evaluation of over 20 key suppliers using direct questionnaires to assess their social and environmental responsibility. The results demonstrated significant awareness and monitoring of these topics.
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.
Mr M Campione
Director
8 May 2025
BLUE EARTH DIAGNOSTICS LIMITED
DIRECTORS' REPORT
FOR THE YEAR ENDED 31 DECEMBER 2024
- 5 -
The directors present their annual report and financial statements for the year ended 31 December 2024.
Results and dividends
The results for the year are set out on page 11. The Company’s loss after taxation is $18,954,626 (2023: $78,551,344 loss). A business review is included in the strategic report.
The directors have not declared a dividend (2023: $Nil).
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
(Resigned 25 November 2024)
Dr D E Gauden
(Resigned 30 June 2024)
Mr M Campione
(Appointed 30 June 2024)
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 position 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 2024
- 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 18F) in 2023.
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, development and commercialisation of flotufolastat (18F) in China in conjunction with local pharmaceutical group leader).
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, and planning a Phase 2 study.
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 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.
On behalf of the board
Mr M Campione
Director
8 May 2025
BLUE EARTH DIAGNOSTICS LIMITED
DIRECTORS' RESPONSIBILITIES STATEMENT
FOR THE YEAR ENDED 31 DECEMBER 2024
- 7 -
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:
select suitable accounting policies and then apply them consistently;
make judgements and accounting estimates that are reasonable and prudent;
state whether applicable UK Accounting Standards have been followed, subject to any material departures disclosed and explained in the financial statements;
prepare the financial statements on the going concern basis unless it is inappropriate to presume that the company 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 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.
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 2024 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:
give a true and fair view of the state of the company's affairs as at 31 December 2024 and of its loss for the year then ended;
have been properly prepared in accordance with United Kingdom Generally Accepted Accounting Practice; and
have been prepared in accordance with the requirements of the Companies Act 2006.
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.
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:
the information given in the strategic report and the directors' report for the financial year for which the financial statements are prepared is consistent with the financial statements; and
the strategic report and the directors' report have been prepared in accordance with applicable legal requirements.
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:
adequate accounting records have not been kept, or returns adequate for our audit have not been received from branches not visited by us; or
the financial statements are not in agreement with the accounting records and returns; or
certain disclosures of directors' remuneration specified by law are not made; or
we have not received all the information and explanations we require for our audit.
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:
Enquiry of management and those charged with governance around actual and potential litigation and claims as well as actual, suspected and alleged fraud;
Reviewing minutes of meetings of those charged with governance;
Assessing the extent of compliance with the laws and regulations considered to have a direct material effect on the financial statements or the operations of the company through enquiry and inspection;
Reviewing financial statement disclosures and testing to supporting documentation to assess compliance with applicable laws and regulations;
Performing audit work over the risk of management bias and override of controls, including testing of journal entries and other adjustments for appropriateness, evaluating the business rationale of significant transactions outside the normal course of business and reviewing accounting estimates for indicators of potential bias.
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.
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
9 May 2025
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 2024
- 11 -
2024
2023
Notes
$
$
Turnover
3
71,227,233
14,131,687
Cost of sales
(39,430,454)
(22,809,389)
Gross profit/(loss)
31,796,779
(8,677,702)
Research and development expenses
(16,895,826)
(19,496,432)
Administrative expenses
(19,085,626)
(25,970,130)
Sales and marketing expenses
(33,912,378)
(29,582,326)
Other operating income
2,514,553
4,510,858
Operating loss
5
(35,582,498)
(79,215,732)
Interest receivable and similar income
9
8,399
851,234
Dividend income
12,000,000
-
Interest payable and similar expenses
(626,357)
(296,637)
Loss before taxation
(24,200,456)
(78,661,135)
Tax on loss
10
789,636
109,791
Loss for the financial year
(23,410,820)
(78,551,344)
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 2024
31 December 2024
- 12 -
2024
2023
Notes
$
$
$
$
Fixed assets
Intangible assets
11
15,573,261
19,613,815
Tangible assets
12
29,492
59,376
Investments
13
568
568
15,603,321
19,673,759
Current assets
Stocks
15
1,965,513
1,288,372
Debtors
16
25,237,586
6,088,634
Cash at bank and in hand
5,615,770
27,203,099
12,992,776
Creditors: amounts falling due within one year
17
(49,606,597)
(15,135,738)
Net current liabilities
(22,403,498)
(2,142,962)
Total assets less current liabilities
(6,800,177)
17,530,797
Creditors: amounts falling due after more than one year
18
(880,905)
Provisions for liabilities
Provisions
20
5,960,751
6,000,000
Deferred tax liability
21
72,117
72,117
(6,032,868)
(6,072,117)
Net (liabilities)/assets
(12,833,045)
10,577,775
Capital and reserves
Called up share capital
23
29,210,175
29,210,175
Share premium account
1,222,012
1,222,012
Profit and loss reserves
(43,265,232)
(19,854,412)
Total equity
(12,833,045)
10,577,775
The financial statements were approved by the board of directors and authorised for issue on 8 May 2025 and are signed on its behalf by:
Mr M Campione
Director
Company Registration No. 08773116
BLUE EARTH DIAGNOSTICS LIMITED
STATEMENT OF CHANGES IN EQUITY
FOR THE YEAR ENDED 31 DECEMBER 2024
- 13 -
Share capital
Share premium account
Profit and loss reserves
Total
$
$
$
$
Balance at 1 January 2023
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
Year ended 31 December 2024:
Loss and total comprehensive income for the year
-
-
(23,410,820)
(23,410,820)
Balance at 31 December 2024
29,210,175
1,222,012
(43,265,232)
(12,833,045)
BLUE EARTH DIAGNOSTICS LIMITED
NOTES TO THE FINANCIAL STATEMENTS
FOR THE YEAR ENDED 31 DECEMBER 2024
- 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 USD, 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:
Section 7 ‘Statement of Cash Flows’: Presentation of a statement of cash flow and related notes and disclosures;
Section 11 ‘Basic Financial Instruments’ and Section 12 ‘Other Financial Instrument Issues: Interest income/expense and net gains/losses for financial instruments not measured at fair value; basis of determining fair values; details of collateral, loan defaults or breaches, details of hedges, hedging fair value changes recognised in profit or loss and in other comprehensive income;
Section 33 ‘Related Party Disclosures’: Compensation for key management personnel and transactions between wholly owned members of the group.
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.
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.
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.
BLUE EARTH DIAGNOSTICS LIMITED
NOTES TO THE FINANCIAL STATEMENTS (CONTINUED)
FOR THE YEAR ENDED 31 DECEMBER 2024
1
Accounting policies
(Continued)
- 15 -
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.
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 2024
1
Accounting policies
(Continued)
- 16 -
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.
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.
BLUE EARTH DIAGNOSTICS LIMITED
NOTES TO THE FINANCIAL STATEMENTS (CONTINUED)
FOR THE YEAR ENDED 31 DECEMBER 2024
1
Accounting policies
(Continued)
- 17 -
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.
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.
BLUE EARTH DIAGNOSTICS LIMITED
NOTES TO THE FINANCIAL STATEMENTS (CONTINUED)
FOR THE YEAR ENDED 31 DECEMBER 2024
1
Accounting policies
(Continued)
- 18 -
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.
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.
BLUE EARTH DIAGNOSTICS LIMITED
NOTES TO THE FINANCIAL STATEMENTS (CONTINUED)
FOR THE YEAR ENDED 31 DECEMBER 2024
1
Accounting policies
(Continued)
- 19 -
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.
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.
Key sources of estimation uncertainty
The estimates and assumptions which have a significant risk of causing a material adjustment to the carrying amount of assets and liabilities are as follows.
Provisions
Provisions are calculated as the most likely scenario for the potential cost based on external counsel and past experience. For further details see note 20.
BLUE EARTH DIAGNOSTICS LIMITED
NOTES TO THE FINANCIAL STATEMENTS (CONTINUED)
FOR THE YEAR ENDED 31 DECEMBER 2024
- 20 -
3
Turnover and other revenue
2024
2023
$
$
Turnover analysed by class of business
Sale of Axumin
4,808,201
11,694,828
Sale of Posluma
66,419,030
2,436,859
71,227,231
14,131,687
2024
2023
$
$
Turnover analysed by geographical market
Europe
950,885
1,145,792
United States of America
70,276,346
12,985,895
71,227,231
14,131,687
2024
2023
$
$
Other revenue
Interest income
8,399
851,234
Dividends received
12,000,000
-
4
Exceptional items
2024
2023
$
$
Expenditure
Exceptional item - Provision for customer rebate program
-
6,000,000
Exceptional item - Intangibles impairment
5,000,000
4,900,000
5,000,000
10,900,000
Refer to note 20 for detail on the provision for customer rebates program and note 11 for the intangible impairment.
5
Operating loss
2024
2023
Operating loss for the year is stated after charging:
$
$
Exchange losses
106,406
677,225
Research and development costs
16,895,827
19,496,432
Depreciation of owned tangible fixed assets
68,643
119,507
Amortisation of intangible assets
824,024
693,049
Impairment of intangible assets
5,000,000
4,900,000
Operating lease charges
627,897
620,760
BLUE EARTH DIAGNOSTICS LIMITED
NOTES TO THE FINANCIAL STATEMENTS (CONTINUED)
FOR THE YEAR ENDED 31 DECEMBER 2024
- 21 -
6
Auditor's remuneration
2024
2023
Fees payable to the company's auditor and associates:
$
$
For audit services
Audit of the financial statements of the company
113,020
98,124
For other services
Taxation compliance services
11,585
11,744
All other non-audit services
3,581
4,010
15,166
15,754
7
Employees
The average monthly number of persons (including directors) employed by the company during the year was:
2024
2023
Number
Number
Research and development
13
18
Medical Affairs
4
4
Regulatory
4
5
Sales and Marketing
6
5
General and Administration
20
18
Total
47
50
Their aggregate remuneration comprised:
2024
2023
$
$
Wages and salaries
8,265,162
6,701,949
Social security costs
865,706
842,819
Pension costs
598,905
543,654
9,729,773
8,088,422
8
Directors' remuneration
2024
2023
$
$
Remuneration for qualifying services
222,149
321,964
Company pension contributions to defined contribution schemes
19,898
28,845
242,047
350,809
BLUE EARTH DIAGNOSTICS LIMITED
NOTES TO THE FINANCIAL STATEMENTS (CONTINUED)
FOR THE YEAR ENDED 31 DECEMBER 2024
8
Directors' remuneration
(Continued)
- 22 -
Remuneration disclosed above include the following amounts paid to the highest paid director:
2024
2023
$
$
Remuneration for qualifying services
147,837
291,964
Company pension contributions to defined contribution schemes
13,230
26,145
There were 2 (2023: 2) paid directors during the year. All other directors are remunerated through other group companies.
9
Interest receivable and similar income
2024
2023
$
$
Interest income
Interest on bank deposits
8,399
851,234
Other income from investments
Dividends received
12,000,000
Total income
12,008,399
851,234
Bank interest receivable includes $8k (2023: $847k) from a cash pooling program managed by Bracco Imaging s.p.A.
10
Taxation
2024
2023
$
$
Current tax
UK corporation tax on profits for the current period
(543,806)
Adjustments in respect of prior periods
(245,830)
(109,791)
Total current tax
(789,636)
(109,791)
BLUE EARTH DIAGNOSTICS LIMITED
NOTES TO THE FINANCIAL STATEMENTS (CONTINUED)
FOR THE YEAR ENDED 31 DECEMBER 2024
10
Taxation
(Continued)
- 23 -
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:
2024
2023
$
$
Loss before taxation
(24,200,456)
(78,661,135)
Expected tax credit based on the standard rate of corporation tax in the UK of 25.00% (2023: 25.00%)
(6,050,114)
(19,665,284)
Tax effect of expenses that are not deductible in determining taxable profit
1,483,961
Tax effect of income not taxable in determining taxable profit
(386,655)
Unutilised tax losses carried forward
5,506,308
18,567,978
Adjustments in respect of prior years
(245,830)
(109,791)
Taxation credit for the year
(789,636)
(109,791)
11
Intangible fixed assets
Patents & licences
$
Cost
At 1 January 2024
30,992,469
Additions
1,783,470
At 31 December 2024
32,775,939
Amortisation and impairment
At 1 January 2024
11,378,654
Amortisation charged for the year
824,024
Impairment losses
5,000,000
At 31 December 2024
17,202,678
Carrying amount
At 31 December 2024
15,573,261
At 31 December 2023
19,613,815
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.
BLUE EARTH DIAGNOSTICS LIMITED
NOTES TO THE FINANCIAL STATEMENTS (CONTINUED)
FOR THE YEAR ENDED 31 DECEMBER 2024
- 24 -
12
Tangible fixed assets
Leasehold improvements
Fixtures and fittings
Computers
Total
$
$
$
$
Cost
At 1 January 2024
227,350
109,030
412,821
749,201
Additions
38,759
38,759
At 31 December 2024
227,350
109,030
451,580
787,960
Depreciation and impairment
At 1 January 2024
206,304
102,593
380,928
689,825
Depreciation charged in the year
21,046
4,465
43,132
68,643
At 31 December 2024
227,350
107,058
424,060
758,468
Carrying amount
At 31 December 2024
1,972
27,520
29,492
At 31 December 2023
21,046
6,437
31,893
59,376
13
Fixed asset investments
2024
2023
Notes
$
$
Investments in subsidiaries
14
568
568
14
Subsidiaries
Details of the company's subsidiaries at 31 December 2024 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 197 First Avenue, Suite 220, Needham, MA 02494, United States of America and Blue Earth Ireland Limited is at 6th Floor, 2 Grand Canal Square, Dublin 2, Ireland.
15
Stocks
2024
2023
$
$
Raw materials and consumables
1,965,513
1,288,372
Raw materials recognised as cost of sales in the period amounted to $1,690,932 (2023: $324,577).
The write down of stocks to net realisable value amounted to $896,594 (2023: $896,594).
BLUE EARTH DIAGNOSTICS LIMITED
NOTES TO THE FINANCIAL STATEMENTS (CONTINUED)
FOR THE YEAR ENDED 31 DECEMBER 2024
- 25 -
16
Debtors
2024
2023
Amounts falling due within one year:
$
$
Trade debtors
21,427,231
2,423,218
Corporation tax recoverable
788,848
Amounts owed by group undertakings
885,680
2,331,268
Other debtors
465,722
165,944
Prepayments and accrued income
1,670,105
1,168,204
25,237,586
6,088,634
Amounts owed by group undertakings comprise of intercompany balances that are unsecured, interest free and repayable on demand.
17
Creditors: amounts falling due within one year
2024
2023
Notes
$
$
Bank loans and overdrafts
19
22,766,215
Trade creditors
6,519,241
4,384,271
Amounts owed to group undertakings
8,185,382
3,945,742
Corporation tax
(936,273)
Other creditors
198,946
256,100
Accruals and deferred income
11,936,813
7,485,898
49,606,597
15,135,738
Amounts owed to group undertakings comprise of intercompany balances that are unsecured, interest free and repayable on demand.
18
Creditors: amounts falling due after more than one year
2024
2023
$
$
Accruals and deferred income
880,905
Long term benefit plan related to a management incentive programme implemented following the acquisition of the company by Bracco Imaging S.p.A on 31 July 2019. The long term benefit plan was paid in May 2024.
BLUE EARTH DIAGNOSTICS LIMITED
NOTES TO THE FINANCIAL STATEMENTS (CONTINUED)
FOR THE YEAR ENDED 31 DECEMBER 2024
- 26 -
19
Loans and overdrafts
2024
2023
$
$
Bank overdrafts
22,766,215
Payable within one year
22,766,215
Bank overdrafts relate to intercompany cash pooling balances and are unsecured. Interest is charged at 3.48% on EUR balances and 5.19% on USD balances and is repayable on demand.
20
Provisions for liabilities
2024
2023
$
$
Provision for customer rebate program
4,250,000
6,000,000
Medicaid rebate program
350,000
-
Royalty provision
1,360,751
-
5,960,751
6,000,000
Movements on provisions:
Provision for customer rebate program
Medicaid rebate program
Royalty provision
Total
$
$
$
$
At 1 January 2024
6,000,000
839,312
-
6,839,312
Additional provisions in the year
-
-
1,360,751
1,360,751
Reversal of provision
(1,750,000)
(362,030)
-
(2,112,030)
Utilisation of provision
-
(127,282)
-
(127,282)
At 31 December 2024
4,250,000
350,000
1,360,751
5,960,751
This nature of the customer rebate 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 $4,250,000.
This nature of the Medicaid rebate provision is that of the potential costs to customers as part of a medicaid program from the sales of Axumin and Posluma. This is expected to be settled within one year with a best estimate of $350,000. $839,312 opening balance was included in accruals for the year ended 31 December 2023.
The nature of the royalty provision is that of expected payments to be made in contractual royalties to suppliers for Axumin dependent on levels of future sales.
BLUE EARTH DIAGNOSTICS LIMITED
NOTES TO THE FINANCIAL STATEMENTS (CONTINUED)
FOR THE YEAR ENDED 31 DECEMBER 2024
- 27 -
21
Deferred taxation
The following are the major deferred tax liabilities and assets recognised by the company and movements thereon:
Liabilities
Liabilities
2024
2023
Balances:
$
$
Fixed asset timing differences
72,117
72,117
There were no deferred tax movements in the year.
Deferred tax has been calculated at a rate of 25%.
22
Retirement benefit schemes
2024
2023
Defined contribution schemes
$
$
Charge to profit or loss in respect of defined contribution schemes
598,905
543,654
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 $Nil (2023: $87,408).
The total expense relating to these plans in the current year was $598,905 (2023: $543,654).
23
Share capital
2024
2023
2024
2023
Ordinary share capital
Number
Number
$
$
Authorised
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 (2023: $Nil).
24
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:
2024
2023
$
$
Within one year
544,744
267,903
Between two and five years
771,721
1,316,465
267,903
BLUE EARTH DIAGNOSTICS LIMITED
NOTES TO THE FINANCIAL STATEMENTS (CONTINUED)
FOR THE YEAR ENDED 31 DECEMBER 2024
24
Operating lease commitments
(Continued)
- 28 -
During the period $627,897 (2023: $620,760) was recognised as an expense in the profit and loss account in respect of operating lease expense.
25
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.
2024-12-312024-01-01falsefalsefalseCCH SoftwareCCH Accounts Production 2025.100No description of principal activityMr R DesiminiMr C Y PetitMr F R BraccoMr F TedoldiMr A VismaraDr D E GaudenMr M CampioneMs R Mowat087731162024-01-012024-12-3108773116bus:Director12024-01-012024-12-3108773116bus:Director22024-01-012024-12-3108773116bus:Director32024-01-012024-12-3108773116bus:Director42024-01-012024-12-3108773116bus:Director72024-01-012024-12-3108773116bus:CompanySecretary12024-01-012024-12-3108773116bus:Director52024-01-012024-12-3108773116bus:Director62024-01-012024-12-3108773116bus:RegisteredOffice2024-01-012024-12-31087731162024-12-31087731162023-01-012023-12-3108773116core:RetainedEarningsAccumulatedLosses2023-01-012023-12-3108773116core:RetainedEarningsAccumulatedLosses2024-01-012024-12-3108773116core:OtherResidualIntangibleAssets2024-12-3108773116core:OtherResidualIntangibleAssets2023-12-3108773116core:PatentsTrademarksLicencesConcessionsSimilar2024-12-3108773116core:PatentsTrademarksLicencesConcessionsSimilar2023-12-31087731162023-12-3108773116core:LeaseholdImprovements2024-12-3108773116core:FurnitureFittings2024-12-3108773116core:ComputerEquipment2024-12-3108773116core:LeaseholdImprovements2023-12-3108773116core:FurnitureFittings2023-12-3108773116core:ComputerEquipment2023-12-3108773116core:CurrentFinancialInstrumentscore:WithinOneYear2024-12-3108773116core:CurrentFinancialInstrumentscore:WithinOneYear2023-12-3108773116core:Non-currentFinancialInstrumentscore:AfterOneYear2024-12-3108773116core:Non-currentFinancialInstrumentscore:AfterOneYear2023-12-3108773116core:CurrentFinancialInstruments2024-12-3108773116core:CurrentFinancialInstruments2023-12-3108773116core:ShareCapital2024-12-3108773116core:ShareCapital2023-12-3108773116core:SharePremium2024-12-3108773116core:SharePremium2023-12-3108773116core:RetainedEarningsAccumulatedLosses2024-12-3108773116core:RetainedEarningsAccumulatedLosses2023-12-3108773116core:ShareCapital2022-12-3108773116core:SharePremium2022-12-3108773116core:RetainedEarningsAccumulatedLosses2022-12-3108773116core:ShareCapitalOrdinaryShareClass12024-12-3108773116core:ShareCapitalOrdinaryShareClass12023-12-3108773116core:IntangibleAssetsOtherThanGoodwill2024-01-012024-12-3108773116core:PatentsTrademarksLicencesConcessionsSimilar2024-01-012024-12-3108773116core:LeaseholdImprovements2024-01-012024-12-3108773116core:FurnitureFittings2024-01-012024-12-3108773116core:ComputerEquipment2024-01-012024-12-3108773116core:UKTax2024-01-012024-12-3108773116core:UKTax2023-01-012023-12-3108773116core:PatentsTrademarksLicencesConcessionsSimilar2023-12-3108773116core:PatentsTrademarksLicencesConcessionsSimilarcore:ExternallyAcquiredIntangibleAssets2024-01-012024-12-3108773116core:LeaseholdImprovements2023-12-3108773116core:FurnitureFittings2023-12-3108773116core:ComputerEquipment2023-12-31087731162023-12-3108773116core:Non-currentFinancialInstruments2024-12-3108773116core:Non-currentFinancialInstruments2023-12-3108773116core:Subsidiary12024-01-012024-12-3108773116core:Subsidiary22024-01-012024-12-3108773116core:Subsidiary112024-01-012024-12-3108773116core:Subsidiary222024-01-012024-12-3108773116bus:OrdinaryShareClass12024-01-012024-12-3108773116bus:OrdinaryShareClass12024-12-3108773116bus:OrdinaryShareClass12023-12-3108773116core:WithinOneYear2024-12-3108773116core:WithinOneYear2023-12-3108773116core:BetweenTwoFiveYears2024-12-3108773116core:BetweenTwoFiveYears2023-12-3108773116bus:PrivateLimitedCompanyLtd2024-01-012024-12-3108773116bus:FRS1022024-01-012024-12-3108773116bus:Audited2024-01-012024-12-3108773116bus:FullAccounts2024-01-012024-12-31xbrli:purexbrli:sharesiso4217:GBP