Full Press Release Details
1. Report of the board of directors
This report of the board of directors has been
prepared in accordance with the Articles 3:5, 3:6, 1 and 3:32, 1 of the Belgian Companies and Associations Code of 23 March
2019 (as amended) (the "Belgian Companies and Associations Code" or "BCAC") and relates to the position
of MDxHealth SA, a company domiciled and incorporated in Belgium (the "Company", and together with its subsidiaries,
"MDxHealth"), and the Company's statutory and consolidated annual accounts for the financial year ended on December
results, risks and uncertainties
discussion and analysis of the statutory financial statements of 2024 and 2023
The statutory annual accounts presented
in this section of the board of directors' report have been prepared by the board of directors, which, on April 21, 2025 authorised
them to be published. The annual accounts were signed on behalf of the Company by Koen Hoffman, the Chairman of the board of directors.
The annual accounts will be submitted to the shareholders for final approval during the ordinary general shareholders' meeting to
be held on May 28, 2025.
Sales and services for the financial year ending
December 31, 2024 amounted to EUR 3,979,160 compared to EUR 3,233,610 for the financial year ending December 31, 2023. Turnover
for the financial year 2024 primarily includes licensing revenue obtained from US subsidiaries, which was up from the previous year due
to increased royalty income from MDxHealth Inc.
of sales and services
The cost of sales and services include mainly
insurance, consultancy, legal and audit fees.
Miscellaneous services and goods decreased from
EUR 8,614,370 in 2023 to EUR 6,845,455 in 2024, meaning a decrease of EUR 1,768,915. This is explained by a decrease in insurance,
consultancy & legal fees, which is partially offset by an increase in the costs incurred by listing on the NASDAQ Capital Market and
The operating result went from a loss of EUR 7,493,015
in 2023 to a loss of EUR 5,865,643 in 2024, mainly due to evolution of miscellaneous services and goods as explained here above, slightly
higher payroll costs and the increased amortization resulting from the capitalization of the intangible asset resulting from the 2023
earn-out related to the GPS acquisition.
The financial results are, on one hand, composed
of financial income from interests on intercompany receivables, bank interests, positive exchange rate differences and in 2024 a write-back
of amounts written down financial fixed assets, which amounted to EUR 6,131,384 in 2023 and EUR 20,256,406 in 2024. On the other
hand, debt charges, other financial expenses and non-recurring financial expenses, which amounted to EUR 27,007,673 in 2023 and decreased
to EUR 6,991,254 in 2024.
In 2024, the net financial result corresponds
to a profit of EUR 13,265,152 compared to a loss of EUR 20,876,289 in 2023 mainly resulting from the valuation of the intercompany
current accounts which reversed from a non-recurring financial charge of EUR 20,217,655 in 2023 to a non-recurring financial gain of EUR
Debt charges decreased by EUR 679,454 which can
be explained by only 4 months of interest charges and settlement expenses for the Innovatus loan following repayment on 1 May 2024 compared
to 12 months of interest charges in 2023. The repayment of Innovatus was done through a partial repayment of the intercompany receivable
by the US subsidiary MDxHealth Inc. that has taken up the Orbimed loan as from 1 May 2024.
The Company ended the 2024 financial year with
a net profit of EUR 7,031,447 compared to a net loss of EUR 28,370,081 the previous year.
working capital and sources of financing
and cash equivalents amounted to EUR 42,763,230
as of December 31, 2024, compared to EUR 18,851,952 on December 31, 2023. Cash and cash equivalents were higher at year-end due to
the recent capital increase. Furthermore, On May 1, 2024, the Company's U.S. subsidiary closed a $100 million loan and security
agreement with funds managed by OrbiMed Advisors LLC (described in more detail below under the section "Orbimed Credit Agreement").
The U.S. subsidiary drew down $55 million from this loan, replacing the Company's existing $35 million debt facility with Innovatus,
thereby reducing the Company's current account by the same amount.
on the approval of the statutory financial statements
The statutory annual accounts have been prepared
in accordance with generally accepted accounting principles in Belgium, and present a true and fair view of the various activities conducted
by the Company during the past financial year. Mr. Mike McGarrity, the CEO and managing director, declares, on behalf of the board
of directors that, to the best of the board's knowledge, the statutory annual accounts, prepared in accordance with generally accepted
accounting principles in Belgium, present a true and fair view of the assets and liabilities of the Company, as well as the financial
situation and operating results of the Company.
Based on the annual accounts, the following can
The Company closed its annual accounts with a
net profit of EUR 7,399,143. This net gain is primarily driven by higher financial income largely resulting from a reversal of previously
accounted for impairments on intercompany receivable position which is offsetting the operational loss incurred in current year.
The Company's subscribed capital amounts
to EUR 204,245,492.10. Share premiums amount to EUR 126,480,632.
The Company has no legal reserves.
A cumulative loss recorded at the closing of the
annual accounts amounts to EUR 196,464,303. The Company is not required to set aside additional sums.
We propose carrying forward the profit for the
financial year as follows:
| Profit for the financial year to be allocated | EUR 7,031,447 | ||
| Loss carried forward from previous financial years | EUR 203,495,750 | ||
| Loss to be carried forward | EUR 196,464,303 |
Since the Company has recorded a loss
carried forward, the continuity rules must be justified. The Company has experienced net losses and significant cash outflows from operating
activities since it was founded in 2003 and, as of December 31, 2024, had an accumulated deficit of EUR 196,464,303. Management expects
the Company to continue incurring net losses and experiencing significant cash outflows for at least the next twelve months. Although
these conditions, among others, may raise doubts about the Company's ability to continue as a going concern, the financial statements
have been prepared on a going concern basis. This accounting principle assumes the realization of assets and the settlement of liabilities
in the normal course of business. Achieving profitability will depend on the Company generating sufficient positive cash flows to support
As of December 31, 2024, the Company
had cash and cash equivalents of EUR 42,763,230. Considering the financial position described above and based on the latest business
plan, particularly the Company's expected ability to obtain additional funding through borrowings, equity financing, or other means,
management believes that the Company has sufficient liquidity to continue its operations for at least the next twelve months from the
date of publication of these financial statements. Consequently, the Company has prepared its financial statements under the assumption
of a going concern. This assessment is based on forecasts and projections from management's most recent business plan, as well as
the Company's expected ability to maintain adequate cash levels, as required under certain financial covenants included in the new
credit agreement with Orbimed (through the U.S. subsidiary, but guaranteed by the Company), and to secure additional liquidity through
debt, equity, or other sources.
discussion and analysis of the consolidated financial statements of 2024 and 2023
following consolidated financial statements have been prepared in accordance with the International Financial Reporting Standards (IFRS)
as issued by the International Accounting Standards Board (IASB) and as adopted by the EU ("EU-IFRS") and collectively "IFRS".
The accounting policies and notes are an integral part of these consolidated financial statements. The following consolidated accounts
differ from the non-consolidated statutory annual accounts of MDxHealth, which have been prepared in accordance with Belgian GAAP.
financial statements in this section of the board report have been approved and authorized for issue by the board of directors on April
21, 2025. The financial statements have been signed on behalf of the Company by Koen Hoffman, Chair of the Board of Directors. The financial
statements will be submitted to the shareholders for their final approval at the ordinary general shareholders' meeting to be held
Total revenue for 2024 was $90.0
million, an increase of 28% as compared to total revenue of $70.2 million for 2023. Tissue-based
tests (being GPS and Confirm mdx) comprised 80% of our 2024 revenues and 79% of our 2023 revenues.
Reimbursement for diagnostic tests furnished to
Medicare beneficiaries (typically patients aged 65 or older) is usually based on a fee schedule set by the U.S. Centers for Medicare &
Medicaid Services ("CMS"), a division of the U.S. Department of Health and Human Services ("HHS"). As a Medicare-enrolled
service provider, the Company bills the regional Medicare Administrative Contractor ("MAC") for CMS that covers the region
where the testing service is performed by the Company. The Confirm mdx test obtained a positive Medicare local coverage determination
("LCD") in 2014, the GPS test obtained a positive Medicare coverage LCD in 2015, and the Select mdx test obtained a positive