Full Press Release Details
| I. INTERIM MANAGEMENT REPORT | 2 |
| II. INTERIM CONDENSED UNAUDITED CONSOLIDATED FINANCIAL STATEMENTS MDXHEALTH SA | 3 |
| 1. CONDENSED UNAUDITED CONSOLIDATED STATEMENT OF PROFIT OR LOSS AND OTHER COMPREHENSIVE INCOME | 3 |
| 2. CONDENSED UNAUDITED CONSOLIDATED STATEMENT OF FINANCIAL POSITION | 4 |
| 3. CONDENSED UNAUDITED CONSOLIDATED STATEMENT OF CHANGES IN EQUITY | 5 |
| 4. CONDENSED UNAUDITED CONSOLIDATED STATEMENT OF CASH FLOWS | 6 |
| 5. EXPLANATORY NOTES | 7 |
| III. CORPORATE INFORMATION | 15 |
This Interim Report contains forward-looking statements
and estimates with respect to the anticipated future performance of MDxHealth SA and its wholly-owned subsidiaries (hereinafter "mdxhealth"
or the "Company") and the market in which it operates. Such statements and estimates are based on assumptions and assessments
of known and unknown risks, uncertainties and other factors, which were deemed reasonable but may not prove to be correct. Actual events
are difficult to predict, may depend upon factors that are beyond the company's control, and may turn out to be materially different.
Important factors that could cause actual results, conditions and events to differ materially from those indicated in the forward-looking
statements include, among others, the following: uncertainties associated with the coronavirus (COVID-19) pandemic, including its possible
effects on our operations, and the demand for the Company's products; the Company's ability to successfully and profitably
market its products; the acceptance of its products and services by healthcare providers; the willingness of health insurance companies
and other payers to cover its products and services and adequately reimburse us for such products and services; and the amount and nature
of competition for its products and services. Mdxhealth expressly disclaims any obligation to update any such forward-looking statements
in this Interim Report to reflect any change in its expectations with regard thereto or any change in events, conditions or circumstances
on which any such statement is based unless required by law or regulation. This Interim Report does not constitute an offer or invitation
for the sale or purchase of securities or assets of mdxhealth in any jurisdiction. No securities of mdxhealth may be offered or sold within
the United States without registration under the U.S. Securities Act of 1933, as amended, or in compliance with an exemption therefrom,
and in accordance with any applicable U.S. securities laws.
Key non-audited financials, as of June 30,
Key unaudited consolidated figures for the six
months ended June 30, 2022 (thousands of US dollars, except per share data):
| Jan-June 2022 | Jan-June 2021 | Change | % Change | |||||||||||||
| Services | 12,975 | 10,462 | 2,513 | 24 | % | |||||||||||
| Licenses and royalties | 34 | 269 | (235 | ) | (87 | )% | ||||||||||
| Total Revenue | 13,009 | 10,731 | 2,278 | 21 | % | |||||||||||
| Gross Profit | 5,772 | 5,215 | 557 | 11 | % | |||||||||||
| Operating expenses | (22,795 | ) | (17,658 | ) | (5,137 | ) | 29 | % | ||||||||
| Operating loss | (17,023 | ) | (12,443 | ) | (4,580 | ) | 37 | % | ||||||||
| Net loss | (18,104 | ) | (13,299 | ) | (4,805 | ) | 36 | % | ||||||||
| Basic and diluted loss per share | (0.12 | ) | (0.12 | ) | 0 | 0 | % |
Total revenue for the first half of 2022 was $13.0
million compared to total revenue of $10.7 million for the first half of 2021, an increase of 21%. Services revenue amounted to $13.0
million, an increase of 24% as compared to $10.5 million a year earlier.
Gross profit on products and services for the
first half of 2022 was $5.8 million as compared to $5.2 million for the first half of 2021. Gross margins on products and services declined
to 44.4% for the first half of 2022 as compared to 48.6% for the same period in 2021, primarily due to timing of cash receipts for our
UTI test, which is expected to reverse in the second half of 2022. In addition, we expect coverage of our Select mdx test, as well as
our recently acquired Oncotype GPS business, to contribute further to gross margin growth in the second half of 2022.
Operating expenses in the first half of 2022 were
$22.8 million versus $17.7 million for the first half of 2021, primarily due to additional public company expenses as a result of the
Operating loss and net loss for the first half
of 2022 were $17.0 million and $18.1 million, respectively, with losses increasing compared to $12.4 million and $13.3 million, respectively,
over the same period in 2021, for the reasons stated above.
Justification to continue using the accounting
rules on the basis of going concern
The Company has experienced net losses and significant
cash used in operating activities since its inception in 2003, and as of June 30, 2022, had an accumulated deficit of $262.4 million,
a net loss of $18.1 million, and net cash used in operating activities of $15.1 million. Management expects the Company to continue to
incur net losses and have significant cash outflows for at least the next twelve months. While these conditions, among others, could raise
doubt about its ability to continue as a going concern, these consolidated financial statements have been prepared assuming that the Company
will continue as a going concern. This basis of accounting contemplates the recovery of its assets and the satisfaction of liabilities
in the normal course of business. A successful transition to attaining profitable operations is dependent upon achieving a level of positive
cash flows adequate to support the Company's cost structure.
As of June 30, 2022, the Company had cash and
cash equivalents of $40.0 million. Taking into account the above financial situation and on the basis of the most recent business plan,
the Company believes that it has sufficient cash to be able to continue its operations for at least the next twelve months from the date
of issuance of these financial statements, and accordingly has prepared the consolidated financial statements assuming that it will continue
as a going concern. This assessment is based on forecasts and projections within management's most recent business plan, which takes
into account the Company's acquisition of the Oncotype DX GPS business from Exact Sciences (discussed further in Footnote 10 -
Subsequent Events) as well as the Company's expected ability to realize cost reductions should these forecasts and projections not
Principal risks related to the business
The principal risks related to the mdxhealth's
business activities have been outlined in the 2021 Annual Report, which is available on the internet at www.mdxhealth.com/investors/financials
Declaration of responsible persons
The Board of Directors of MDxHealth SA, represented
by all its members, declares that, as far as it is aware, the financial statements in this Interim Report, made up according to the applicable
standards for financial statements, give a true and fair view of the equity, financial position and the results of the company and its
consolidated companies. The Board of Directors of MDxHealth SA, represented by all its members, further declares that this Interim Report
gives a true and fair view on the information that has to be contained herein. The condensed consolidated interim financial statements
have been prepared in accordance with International Accounting Standard (IAS) 34 (Interim Financial Reporting) as issued by the International
Accounting Standards Board, or IASB, and as adopted by the EU.
II. INTERIM CONDENSED UNAUDITED CONSOLIDATED FINANCIAL STATEMENTS
For the six months ended June 30, 2022
In thousands of USD (except per share data)
Condensed unaudited consolidated statement of profit or loss
| Note | Jan-June 2022 | Jan-June 2021 | ||||||||
| Services | 4 | 12,975 | 10,462 | |||||||
| Licenses | 4 | 0 | 250 | |||||||
| Royalties and other revenues | 4 | 34 | 19 | |||||||
| Revenues | 13,009 | 10,731 | ||||||||
| Cost of goods & services sold | (7,237 | ) | (5,516 | ) | ||||||
| Gross Profit | 5,772 | 5,215 | ||||||||
| Research and development expenses | (3,585 | ) | (2,823 | ) | ||||||
| Selling and marketing expenses | (9,848 | ) | (8,247 | ) | ||||||
| General and administrative expenses | (9,636 | ) | (6,739 | ) | ||||||
| Other operating income, net | 274 | 151 | ||||||||
| Operating loss | (17,023 | ) | (12,443 | ) | ||||||
| Financial income | 27 | 0 | ||||||||
| Financial expenses | (1,107 | ) | (856 | ) | ||||||
| Loss before income tax | (18,103 | ) | (13,299 | ) | ||||||
| Income tax | (1 | ) | 0 | |||||||
| Loss for the period | (18,104 | ) | (13,299 | ) | ||||||
| Loss for the period attributable to the parent | (18,104 | ) | (13,299 | ) | ||||||
| Loss per share attributable to parent | ||||||||||
| Basic and diluted | (0.12 | ) | (0.12 | ) | ||||||
| Condensed unaudited consolidated statement of other comprehensive income | ||||||||||
| Loss for the period | (18,104 | ) | (13,299 | ) | ||||||
| Other comprehensive income | ||||||||||
| Items that will be reclassified to profit or loss: | ||||||||||
| Exchange differences arising from translation of foreign operations | 588 | 122 | ||||||||
| Total other comprehensive income | 588 | 122 | ||||||||
| Total comprehensive loss for the period (net of tax) | (17,516 | ) | (13,177 | ) |
| In thousands of USD | ||||||||||
| Note | as of June 30, 2022 | as of December 31, 2021 | ||||||||
| ASSETS | ||||||||||
| Intangible assets | 3,104 | 3,448 | ||||||||
| Property, plant and equipment | 2,364 | 1,671 | ||||||||
| Right-of-use assets | 3,168 | 3,347 | ||||||||
| Non-current assets | 8,636 | 8,466 | ||||||||
| Inventories | 2,089 | 1,911 | ||||||||
| Trade receivables | 6 | 5,036 | 4,582 | |||||||
| Prepaid expenses and other current assets | 2,724 | 1,615 | ||||||||
| Cash and cash equivalents | 6 | 40,025 | 58,498 | |||||||
| Current assets | 49,874 | 66,606 | ||||||||
| Total assets | 58,510 | 75,072 | ||||||||
| EQUITY | ||||||||||
| Share capital | 128,454 | 128,454 | ||||||||
| Issuance premium | 153,177 | 153,177 | ||||||||
| Accumulated deficit | (262,406 | ) | (244,302 | ) | ||||||
| Share-based compensation | 10,986 | 10,607 | ||||||||
| Foreign currency translation reserves | (449 | ) | (1,037 | ) | ||||||
| Total equity | 29,762 | 46,899 | ||||||||
| LIABILITIES | ||||||||||
| Deferred tax liability | 129 | 0 | ||||||||
| Loans and borrowings | 5 | 3,291 | 7,651 | |||||||
| Lease liabilities | 5 | 2,454 | 2,624 | |||||||
| Other non-current financial liabilities | 5/6/7 | 1,934 | 1,466 | |||||||
| Non-current liabilities | 7,808 | 11,741 | ||||||||
| Loans and borrowings | 5 | 7,760 | 4,441 | |||||||
| Lease liabilities | 5 | 870 | 840 | |||||||
| Trade payables | 6 | 9,836 | 7,455 | |||||||
| Other current liabilities | 2,062 | 2,735 | ||||||||
| Other current financial liabilities | 5/6/7 | 412 | 961 | |||||||
| Current liabilities | 20,940 | 16,432 | ||||||||
| Total liabilities | 28,748 | 28,173 | ||||||||
| Total equity and liabilities | 58,510 | 75,072 |
Attributable to owners of MDxHealth SA
| In thousands of USD, except number of shares | Number of shares | Share capital and issuance premium | Retained earnings | Share-based compensation | Translation reserves | Total equity | ||||||||||||||||||
| Note 10 | Note 9 | |||||||||||||||||||||||
| Balance at January 1, 2021 | 90,691,449 | 213,065 | (215,300 | ) | 9,385 | (1,301 | ) | 5,849 | ||||||||||||||||
| Loss for the period | (13,299 | ) | (13,299 | ) | ||||||||||||||||||||
| Other comprehensive income | 122 | 122 | ||||||||||||||||||||||
| Total comprehensive income for the period | (13,299 | ) | 122 | (13,177 | ) | |||||||||||||||||||
| Transactions with owners in their capacity as owners: | ||||||||||||||||||||||||
| Issuance of shares, net of transaction costs | 27,777,777 | 28,336 | 28,336 | |||||||||||||||||||||
| Share-based compensation | 486 | 486 | ||||||||||||||||||||||
| Balance at June 30, 2021 | 118,469,226 | 241,401 | (228,599 | ) | 9,871 | (1,179 | ) | 21,494 | ||||||||||||||||
| Balance at January 1, 2022 | 155,969,226 | 281,631 | (244,302 | ) | 10,607 | (1,037 | ) | 46,899 | ||||||||||||||||
| Loss for the period | (18,104 | ) | (18,104 | ) | ||||||||||||||||||||
| Other comprehensive income | 588 | 588 | ||||||||||||||||||||||
| Total comprehensive income for the period | (18,104 | ) | 588 | (17,516 | ) | |||||||||||||||||||
| Transactions with owners in their capacity as owners: | ||||||||||||||||||||||||
| Share-based compensation | 379 | 379 | ||||||||||||||||||||||
| Balance at June 30, 2022 | 155,969,226 | 281,631 | (262,406 | ) | 10,986 | (449 | ) | 29,762 |
| In thousands of USD | ||||||||||
| Note | Jan-June 2022 | Jan-June 2021 | ||||||||
| CASH FLOWS FROM OPERATING ACTIVITIES | ||||||||||
| Operating loss | (17,023 | ) | (12,443 | ) | ||||||
| Depreciation and amortization | 1,576 | 1,514 | ||||||||
| Share-based compensation | 379 | 486 | ||||||||
| Non-cash fair value change | (20 | ) | (195 | ) | ||||||
| Non-cash foreign exchange rate change | 30 | (339 | ) | |||||||
| Cash generated from operations before working capital changes | (15,058 | ) | (10,977 | ) | ||||||
| Changes in operating assets and liabilities | ||||||||||
| (Increase)/decrease in inventories | (178 | ) | 205 | |||||||
| Increase in receivables | (1,563 | ) | (474 | ) | ||||||
| Increase/(decrease) in payables | 1,708 | (396 | ) | |||||||
| Net cash outflow from operating activities | (15,091 | ) | (11,642 | ) | ||||||
| CASH FLOWS FROM INVESTING ACTIVITIES | ||||||||||
| Purchase of property, plant and equipment | (925 | ) | (411 | ) | ||||||
| Purchase of intangible assets | (451 | ) | 0 | |||||||
| Interests received | 27 | 0 | ||||||||
| Net cash outflow from investing activities | (1,349 | ) | (411 | ) | ||||||
| CASH FLOWS FROM FINANCING ACTIVITIES | ||||||||||
| Proceeds from issuance of shares, net of transaction costs | 0 | 28,336 | ||||||||
| Payment of loan obligation | 5 | (439 | ) | 0 | ||||||
| Payment of lease liability | 5 | (663 | ) | (536 | ) | |||||
| Payment of interest | (511 | ) | (515 | ) | ||||||
| Net cash inflow from financing activities | (1,613 | ) | 27,285 | |||||||
| Net increase in cash and cash equivalents | (18,053 | ) | 15,232 | |||||||
| Cash and cash equivalents at beginning of the period | 58,498 | 15,953 | ||||||||
| Effect of exchange rates | (420 | ) | 133 | |||||||
| Cash and cash equivalents at end of the period | 40,025 | 31,318 |
MDxHealth, SA together with its subsidiaries are
herein referred to as "mdxhealth" or the "Company". Mdxhealth is a company domiciled in Belgium, with offices
and labs in the United States and The Netherlands. The reporting and functional currency of the Company is the U.S. Dollar.
The condensed consolidated interim financial statements
have been prepared in accordance with International Accounting Standard (IAS) 34 - Interim Financial Reporting, as issued by the
International Accounting Standards Board, or IASB, and as adopted by the EU.
These interim consolidated financial statements
do not include all the information required for full annual financial statements and should be read in conjunction with the consolidated
financial statements of the Company as of, and for the year ended, December 31, 2021.
The Company ended the period with $40.0 million
in cash and cash equivalents as of June 30, 2022, and continued to incur losses. The Company is expecting continued losses and negative
operating cash flows in the coming twelve months. Taking into account the above financial situation and on the basis of the most recent
business plan, the Company believes that it has sufficient cash to be able to continue its operations for at least the next twelve months
from the date of issuance of these financial statements, and accordingly has prepared the consolidated financial statements assuming that
it will continue as a going concern. This assessment is based on forecasts and projections within management's most recent business
plan as well as the Company's expected ability to realize cost reductions should these forecasts and projections not be met.
The Company applies the International Financial
Reporting Standards (IFRS) as issued by the IASB and as adopted by the EU. The same accounting policies, presentation and methods of computation
have been followed in these condensed financial statements as were applied in the preparation of the Company's financial statements
for the year ended December 31, 2021. No amendments to existing standards that became applicable as from January 1, 2022, have a material
impact on the consolidated financial statements or accounting policies.
The preparation of the interim condensed financial
statements in compliance with IAS 34 requires the use of certain critical accounting estimates. It also requires the Company's management
to exercise judgment in applying the Company's accounting policies. The Company has applied the same accounting policies and there
have been no material revisions to the nature and amount of estimates and judgments in its interim condensed financial statements.
The COVID-19 outbreak has impacted management's
estimates, judgments and assumptions, and could impact the Company's ability to develop business, conduct operations, and obtain
components used in its business. The situation is continuously evolving, therefore the extent to which the COVID-19 outbreak will continue
to impact business and the economy is highly uncertain and is extremely difficult to predict. Accordingly, the Company cannot accurately