Full Press Release Details
| I. INTERIM MANAGEMENT REPORT | 2 | |||
| II. INTERIM CONDENSED UNAUDITED CONSOLIDATED FINANCIAL STATEMENTS MDXHEALTH SA | 4 | |||
| 1. | CONDENSED UNAUDITED CONSOLIDATED STATEMENT OF PROFIT OR LOSS AND OTHER COMPREHENSIVE INCOME | 4 | ||
| 2. | CONDENSED UNAUDITED CONSOLIDATED STATEMENT OF FINANCIAL POSITION | 5 | ||
| 3. | CONDENSED UNAUDITED CONSOLIDATED STATEMENT OF CHANGES IN EQUITY | 6 | ||
| 4. | CONDENSED UNAUDITED CONSOLIDATED STATEMENT OF CASH FLOWS | 7 | ||
| 5. | EXPLANATORY NOTES | 8 | ||
| III. CORPORATE INFORMATION | 19 |
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.
INTERIM MANAGEMENT REPORT
non-audited financials, as of June 30, 2023
unaudited consolidated figures for the six months ended June 30, 2023 (thousands of U.S. dollars, except per share data):
| Jan-June 2023 | Jan-June 2022 | Change | % Change | |||||||||||||
| Revenue | 31,445 | 13,009 | 18,436 | 142 | % | |||||||||||
| Gross Profit | 18,705 | 5,772 | 12,933 | 224 | % | |||||||||||
| Operating expenses | (35,165 | ) | (22,795 | ) | (12,370 | ) | 54 | % | ||||||||
| Operating loss | (16,460 | ) | (17,023 | ) | 563 | (3 | )% | |||||||||
| Net loss | (22,335 | ) | (18,104 | ) | (4,231 | ) | 23 | % | ||||||||
| Basic and diluted loss per share | (0.08 | ) | (0.12 | ) | 0.04 | (33 | )% |
revenue for the first half of 2023 was $31.4 million, an increase of 142% as compared to total revenue of $13.0 million for the first
half of 2022. Excluding the GPS revenues, total revenues for the first half were $17.4 million, an increase of 34% compared to the first
half of 2022. H1-2023 revenues of $31.4 million were comprised of $14.0 million from GPS, $12.4 million from Confirm mdx, $3.7 million
from Resolve mdx, with the remaining revenues from Select mdx and other.
profit for H1-2023 was $18.7 million as compared to $5.8 million for H1-2022. Gross margins were 59.5% for H1-2023 as compared to 44.4%
for H1-2022, representing a gross margin improvement of 1,510 basis points, primarily related to our product mix and the addition of
GPS to our product menu.
expenses for the first half of 2023 were $35.2 million, up 54% from $22.8 million for H1-2022, primarily related to the additional field
sales personnel associated with the GPS business.
loss for H1-2023 was $16.5 million, a decrease of 3% over H1-2022, helped by our increased revenues and improved gross margin.
loss for H1-2023 of $22.3 million increased by $4.2 million versus $18.1 million for the prior year period, primarily due to an increase
in financial expenses, of which $3.9 million was non-cash and relates to the fair value adjustment of the GPS contingent consideration,
and the remainder was primarily related to an increase in interest expense from our debt facility.
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, and for the period ended, June 30, 2023, had an accumulated deficit of $310.7
million, a net loss of $22.3 million, and net cash used in operating activities of $9.9 million. Management expects the Company to continue
to incur net losses and have significant cash outflows for at least the next twelve months.
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.
of June 30, 2023, the Company had cash and cash equivalents of $39.5 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, including recent developments related to the Exact Sciences earnout (as detailed in Note
15 "Subsequent events"), as well as the Company's expected ability to realize cost reductions should these forecasts
and projections not be met.
risks related to the business activities
principal risks related to MDxHealth's business activities have been outlined in the 2022 Annual Report, which is available on
the Company's website at www.mdxhealth.com/investors/financials.
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
subsidiaries. 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.
INTERIM CONDENSED UNAUDITED CONSOLIDATED FINANCIAL STATEMENTS OF MDXHEALTH SA
the six months ended June 30, 2023
CONDENSED UNAUDITED CONSOLIDATED STATEMENT OF PROFIT OR LOSS AND OTHER COMPREHENSIVE INCOME
unaudited consolidated statement of profit or loss
| Note | Jan-June 2023 | Jan-June 2022 | ||||||||||
| Services | 5 | $ | 31,345 | $ | 12,975 | |||||||
| Royalties and other revenues | 5 | 100 | 34 | |||||||||
| Revenues | 31,445 | 13,009 | ||||||||||
| Cost of goods & services sold | (12,740 | ) | (7,237 | ) | ||||||||
| Gross Profit | 18,705 | 5,772 | ||||||||||
| Research and development expenses | 6 | (4,560 | ) | (3,585 | ) | |||||||
| Selling and marketing expenses | 6 | (19,029 | ) | (9,848 | ) | |||||||
| General and administrative expenses | 6 | (10,910 | ) | (9,636 | ) | |||||||
| Other operating income, net | (666 | ) | 274 | |||||||||
| Operating loss | (16,460 | ) | (17,023 | ) | ||||||||
| Financial expenses, net: | 10 | |||||||||||
| Contingent consideration fair value adjustments | (3,882 | ) | (197 | ) | ||||||||
| Other financial expenses, net | (1,993 | ) | (883 | ) | ||||||||
| Loss before income tax | (22,335 | ) | (18,103 | ) | ||||||||
| Income tax | - | (1 | ) | |||||||||
| Loss for the period | (22,335 | ) | (18,104 | ) | ||||||||
| Loss for the period attributable to the parent | $ | (22,335 | ) | $ | (18,104 | ) | ||||||
| Loss per share attributable to parent | ||||||||||||
| Basic and diluted | (0.08 | ) | (0.12 | ) | ||||||||
| Condensed unaudited consolidated statement of other comprehensive income | ||||||||||||
| Loss for the period | $ | (22,335 | ) | $ | (18,104 | ) | ||||||
| Other comprehensive income | ||||||||||||
| Items that will be reclassified to profit or loss: | ||||||||||||
| Exchange differences arising from translation of foreign operations | (199 | ) | 588 | |||||||||
| Total other comprehensive income | (199 | ) | 588 | |||||||||
| Total comprehensive loss for the period (net of tax) | $ | (22,534 | ) | $ | (17,516 | ) |
CONDENSED UNAUDITED CONSOLIDATED STATEMENT OF FINANCIAL POSITION
| Thousands of $ | ||||||||||||
| Note | as of June 30, 2023 | as of December 31, 2022 | ||||||||||
| ASSETS | ||||||||||||
| Goodwill | $ | 35,926 | $ | 35,926 | ||||||||
| Intangible assets | 7 | 44,907 | 46,166 | |||||||||
| Property, plant and equipment | 8 | 5,247 | 3,791 | |||||||||
| Right-of-use assets | 4,733 | 4,103 | ||||||||||
| Non-current assets | 90,813 | 89,986 | ||||||||||
| Inventories | 2,674 | 2,327 | ||||||||||
| Trade receivables | 11 | 8,098 | 9,357 | |||||||||
| Prepaid expenses and other current assets | 1,488 | 1,962 | ||||||||||
| Cash and cash equivalents | 39,472 | 15,503 | ||||||||||
| Current assets | 51,732 | 29,149 | ||||||||||
| Total assets | $ | 142,545 | $ | 119,135 | ||||||||
| EQUITY | ||||||||||||
| Share capital | $ | 173,053 | $ | 133,454 | ||||||||
| Issuance premium | 153,177 | 153,177 | ||||||||||
| Accumulated deficit | (310,681 | ) | (288,346 | ) | ||||||||
| Share-based compensation | 11,752 | 11,474 | ||||||||||
| Translation reserve | (643 | ) | (444 | ) | ||||||||
| Total equity | 14 | $ | 26,658 | $ | 9,315 | |||||||
| LIABILITIES | ||||||||||||
| Loans and borrowings | 9 | $ | 35,177 | $ | 34,914 | |||||||
| Lease liabilities | 9 | 3,445 | 3,091 | |||||||||
| Other non-current financial liabilities | 9 | 35,899 | 53,537 | |||||||||
| Non-current liabilities | 74,521 | 91,542 | ||||||||||
| Loans and borrowings | 9 | 640 | 616 | |||||||||
| Lease liabilities | 9 | 1,327 | 1,172 | |||||||||
| Trade payables | 10,681 | 10,178 | ||||||||||
| Other current liabilities | 4,609 | 3,985 | ||||||||||
| Other current financial liabilities | 9 | 24,109 | 2,327 | |||||||||
| Current liabilities | 41,366 | 18,278 | ||||||||||
| Total liabilities | 115,887 | 109,820 | ||||||||||
| Total equity and liabilities | $ | 142,545 | $ | 119,135 |
CONDENSED UNAUDITED CONSOLIDATED STATEMENT OF CHANGES IN EQUITY
to owners of MDxHealth SA
| Thousands of $ , except number of shares | Number of shares | Share capital and issuance premium | Accumulated Deficit | Share-based compensation | Translation reserves | Total equity | ||||||||||||||||||
| Note 14 | Note 13 | |||||||||||||||||||||||
| 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 | |||||||||||
| Balance at January 1, 2023 | 162,880,936 | $ | 286,631 | $ | (288,346 | ) | $ | 11,474 | $ | (444 | ) | $ | 9,315 | |||||||||||
| Loss for the period | (22,335 | ) | (22,335 | ) | ||||||||||||||||||||
| Other comprehensive income | (199 | ) | (199 | ) | ||||||||||||||||||||
| Total comprehensive income for the period | (22,335 | ) | (199 | ) | (22,534 | ) | ||||||||||||||||||
| Transactions with owners in their capacity as owners: | ||||||||||||||||||||||||
| Issuance of shares, net of transaction costs | 107,500,000 | 39,599 | 39,599 | |||||||||||||||||||||
| Share-based compensation | 278 | 278 | ||||||||||||||||||||||
| Balance at June 30, 2023 | 270,380,936 | $ | 326,230 | $ | (310,681 | ) | $ | 11,752 | $ | (643 | ) | $ | 26,658 |
CONDENSED UNAUDITED CONSOLIDATED STATEMENT OF CASH FLOWS
| Thousands of $ | ||||||||||||
| Note | Jan-June 2023 | Jan-June 2022 | ||||||||||
| CASH FLOWS FROM OPERATING ACTIVITIES | ||||||||||||
| Operating loss | $ | (16,460 | ) | $ | (17,023 | ) | ||||||
| Depreciation and amortization | 3,412 | 1,576 | ||||||||||
| Share-based compensation | 278 | 379 | ||||||||||
| Other non-cash transactions | 696 | 10 | ||||||||||
| Cash used in operations before working capital changes | (12,074 | ) | (15,058 | ) | ||||||||
| Changes in operating assets and liabilities | ||||||||||||
| Increase in inventories | (347 | ) | (178 | ) | ||||||||
| Increase in receivables | 1,733 | (1,563 | ) | |||||||||
| Increase in payables | 827 | 1,708 | ||||||||||
| Net cash outflow from operating activities | (9,861 | ) | (15,091 | ) | ||||||||
| CASH FLOWS FROM INVESTING ACTIVITIES | ||||||||||||
| Purchase of property, plant and equipment | (2,153 | ) | (925 | ) | ||||||||
| Interest received | 317 | 27 | ||||||||||
| Acquisition and generation of intangible assets | (980 | ) | (451 | ) | ||||||||
| Net cash outflow from investing activities | (2,816 | ) | (1,349 | ) | ||||||||
| CASH FLOWS FROM FINANCING ACTIVITIES | ||||||||||||
| Proceeds from issuance of shares, net of transaction costs | 39,599 | - | ||||||||||
| Payment of loan obligation | 9 | (318 | ) | (439 | ) | |||||||
| Payment of lease liability | 9 | (712 | ) | (663 | ) | |||||||
| Payment of interest | (1,731 | ) | (511 | ) | ||||||||
| Net cash inflow from financing activities | 36,838 | (1,613 | ) | |||||||||
| Net increase in cash and cash equivalents | 24,161 | (18,053 | ) | |||||||||
| Cash and cash equivalents at beginning of the period | 15,503 | 58,498 | ||||||||||
| Effect of exchange rates | (192 | ) | (420 | ) | ||||||||
| Cash and cash equivalents at end of the period | $ | 39,472 | $ | 40,025 |
Basis of preparation
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
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.
translation of Euro amounts as of June 30, 2023 into U.S. dollars, the official exchange rate quoted as of June 30, 2023 by the European
Central Bank of 1 to $1.087 was used.
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, 2022.
Company ended the period with $39.5 million in cash and cash equivalents as of June 30, 2023, 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 condensed interim financial statements, and accordingly
has prepared the consolidated condensed interim 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, including recent developments related to the
Exact Sciences earnout (as detailed in Note 15 "Subsequent events"), as well as the Company's expected ability to realize
cost reductions should these forecasts and projections not be met.
Significant accounting policies, use of judgments and estimates
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, 2022. No amendments to existing standards that became applicable
as from January 1, 2023, have a material impact on the consolidated financial statements or accounting policies.
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.
detailed in Note 2.7 of the Company's 2022 yearend financial statements, a large portion of the Company's revenues are derived
from Medicare, which reimburses the Company for tests performed on its insured patients once a Local Coverage Determination or "LCD"