Mdxhealth Announces Fourth Quarter and
Full-Year 2023 Financial Results
2023 revenue grew by 89% to $70.2 million;
excluding GPS, revenues up 42%2023 gross margin expanded by 10.7
percentage points over prior yearConference call with Q&A today
at 4:30 PM EST / 22:30 CET
IRVINE, CA, and HERSTAL,
BELGIUM – March 6, 2024 (GlobeNewswire) – MDxHealth SA
(NASDAQ: MDXH) (the "Company" or "mdxhealth"), a commercial-stage
precision diagnostics company, today announced its financial
results for the fourth quarter and year ended December 31,
2023.
Michael K. McGarrity, CEO of mdxhealth,
commented: “Our fourth quarter and full year 2023
results reflect our continued commitment to commercial execution
and operational discipline that has driven significant gross margin
expansion across our business. With each passing quarter, we
continue to build on our position as a leading precision
diagnostics company rooted in our industry-leading technology,
focus on the highest quality customer experience, and our
unwavering commitment towards improving patient outcomes. We remain
well positioned to build upon this success as we actively evaluate
multiple, high-growth opportunities that could further strengthen
and complement our existing menu. In 2024, we expect to deliver
continued topline growth and operating execution that will lead to
adjusted EBITDA profitability in the first half of
2025.”
Key Highlights:
- Completed
transition to sole listing of its shares on NASDAQ
- Secured Medicare
coverage for the Company’s Select mdx test
- Fourth quarter
revenue of $19.4 million, an increase of 50% over prior year
period
- 2023 revenue of
$70.2 million, an increase of 89% or 42% excluding GPS
Financial review for the fourth quarter
and year ended December 31,
2023
|
USD in ‘000 (except per share
data)Unaudited |
|
Three months ended December
31 |
|
Twelve months ended December
31 |
|
|
2023 |
2022 |
% Change |
|
2023 |
2022 |
% Change |
|
Revenue |
|
19,398 |
12,891 |
50% |
|
70,193 |
37,054 |
89% |
|
Cost of goods |
|
(6,727) |
(5,667) |
19% |
|
(26,264) |
(17,835) |
47% |
|
Gross Profit |
|
12,671 |
7,224 |
75% |
|
43,929 |
19,219 |
129% |
|
Operating expenses |
|
(18,977) |
(16,171) |
17% |
|
(71,256) |
(57,119) |
25% |
|
Operating loss |
|
(6,306) |
(8,947) |
(30%) |
|
(27,327) |
(37,900) |
(28%) |
|
Net loss |
|
(10,720) |
(12,438) |
(14%) |
|
(43,100) |
(44,044) |
(2%) |
|
Basic and diluted loss per share |
|
(0.39) |
(0.76) |
(48%) |
|
(1.66) |
(2.78) |
(40%) |
Fourth Quarter 2023 Financial
Results
Revenue increased 50% to $19.4 million compared
to $12.9 million for the prior year. Revenue was comprised of $8.8
million from GPS, $5.9 million from Confirm mdx, $3.2 million from
Resolve mdx, and $1.3 million from Select mdx.
Gross margins were 65.3% compared to 56.0% for
the prior year, an improvement of 9.3 percentage points attributed
to contribution from Select mdx reimbursement, coupled with cost
management and expanded coverage across our menu.
Operating expenses increased 17% to $19.0
million compared to $16.2 million for the prior year, driven by
increases in R&D expense, increased sales and marketing
activity from the GPS acquisition, as well as $1.7 million of
non-recurring expenses, primarily attributed to the transition to a
sole listing on NASDAQ.
Net loss decreased 14% to $10.7 million compared
to $12.4 million for the prior year, driven by the factors
mentioned above, partially offset by an increase of $2.1 million in
financial expenses, of which $1.8 million was non-cash.
Full Year 2023 Financial
Results
Revenue increased 89% to $70.2 million compared
to $37.1 million for the prior year. Excluding GPS, revenue
increased 42% to $39.3 million compared to $27.7 million for the
prior year. Revenue was comprised of $30.9 million from GPS, $24.8
million from Confirm mdx, $9.7 million from Resolve mdx, and $4.5
million from Select mdx.
Gross margins were 62.6% compared to 51.9% for
the prior year, an improvement of 10.7 percentage points attributed
to contribution from Select mdx reimbursement, cost management,
expanded coverage across our menu, and a higher contribution from
GPS to total revenue.
Operating expenses increased 25% to $71.3
million compared to $57.1 million for the prior year, primarily
driven by the acquisition of the GPS test in August 2022, and
includes $2.6 million of non-recurring expenses, primarily
attributed to the transition to a sole listing on NASDAQ.
Net loss decreased 2% to $43.1 million compared
to $44.0 million for the prior year, driven by the factors
mentioned above, partially offset by an increase of $11.4 million
in financial expenses, of which $9.1 million was non-cash and
primarily related to the GPS contingent consideration.
Cash and cash equivalents as of December 31,
2023, were $22.4 million.
Business Update and Outlook for
2024
The Company is maintaining its previously issued
2024 revenue guidance of $79-81 million and confirms its view of
expected adjusted EBITDA profitability in the first half of
2025.
Conference Call
Michael K. McGarrity, Chief Executive Officer
and Ron Kalfus, Chief Financial Officer, will host a conference
call and Q&A session today at 4:30 PM EST / 22:30 CET. The call
will be conducted in English and a replay will be available for 30
days.
To participate in the conference call, please
select your phone number below:
United States: 1-888-886-7786
Belgium: 0800 76018
The Netherlands: 0800 022 7908
United Kingdom: 1-800-652-2435
Webcast:
https://viavid.webcasts.com/starthere.jsp?ei=1655339&tp_key=a93e4440eb
To ensure a timely connection, it is recommended
that users register at least 10 minutes prior to the scheduledstart
time.
About mdxhealthMdxhealth is a
commercial-stage precision diagnostics company that provides
actionable molecular information to personalize patient diagnosis
and treatment. The Company’s tests are based on proprietary
genomic, epigenetic (methylation) and other molecular technologies
and assist physicians with the diagnosis and prognosis of urologic
cancers and other urologic diseases. For more information, visit
mdxhealth.com and follow us on social media at:
twitter.com/mdxhealth, facebook.com/mdxhealth and
linkedin.com/company/mdxhealth.
For more information:
info@mdxhealth.com
LifeSci Advisors (IR & PR)US: +1 949 271
9223
ir@mdxhealth.com
This press release contains forward-looking
statements and estimates with respect to the anticipated future
performance of MDxHealth and the market in which it operates, all
of which involve certain risks and uncertainties. These statements
are often, but are not always, made through the use of words or
phrases such as “potential,” “expect,” “will,” “goal,” “next,”
“potential,” “aim,” “explore,” “forward,” “future,” and “believes”
as well as similar expressions. Forward-looking statements
contained in this release include, but are not limited to,
statements regarding expected future operating results;
expectations for development of new or improved products and
services and their impact on patients; our strategies, positioning,
resources, capabilities and expectations for future events or
performance; and the anticipated benefits of our acquisitions,
including estimated synergies and other financial impacts. 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. Examples of forward-looking statements include, among
others, statements we make regarding expected future operating
results, product development efforts, our strategies, positioning,
resources, capabilities and expectations for future events or
performance. 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: our ability to successfully and profitably market our
products; the acceptance of our products and services by healthcare
providers; our ability to achieve and maintain adequate levels of
coverage or reimbursement for our current and future solutions we
commercialize or may seek to commercialize; the willingness of
health insurance companies and other payers to cover our products
and services and adequately reimburse us for such products and
services; our ability to obtain and maintain regulatory approvals
and comply with applicable regulations; timing, progress and
results of our research and development programs; the period over
which we estimate our existing cash will be sufficient to fund our
future operating expenses and capital expenditure requirements; the
possibility that the anticipated benefits from our business
acquisitions like our acquisition of the Oncotype DX® GPS prostate
cancer business will not be realized in full or at all or may take
longer to realize than expected; and the amount and nature of
competition for our products and services. Other important risks
and uncertainties are described in the Risk Factors sections of our
most recent Annual Report on Form 20-F and in our other reports
filed with the Securities and Exchange Commission. MDxHealth
expressly disclaims any obligation to update any such
forward-looking statements in this release 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 press release 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.
Non-IFRS Measures. The
Company’s reference to adjusted EBITDA is a forward-looking
statement about the Company’s future financial performance, and is
a non-IFRS measure that excludes a number of expense items that are
included in net loss, including adjustments for items like
stock-based compensation, acquisition and integration costs,
impairment of long-lived assets, fair-value adjustment, loan
extinguishment costs, as well as other non-operating, non-recurring
expenses that are difficult to predict for future periods because
the nature of the adjustments pertain to events that have not yet
occurred. As a result, positive adjusted EBITDA may be achieved
while a significant net loss persists. Non-IFRS financial
information has limitations as an analytical tool and should not be
considered in isolation or as a substitute for financial
information presented in accordance with IFRS, and such information
is referenced for supplemental information purposes only.
Management does not forecast many of the excluded items for
internal use, as these are difficult to predict for future periods
because the nature of the adjustments pertain to events that have
not yet occurred. Information reconciling forward-looking non-IFRS
measures to IFRS measures is therefore not available without
unreasonable effort, and is not provided. The occurrence, timing,
and amount of any of the items excluded from IFRS to calculate
non-IFRS measures could significantly impact the Company's IFRS
results.
NOTE: The mdxhealth logo,
mdxhealth, Confirm mdx, Select mdx, Resolve mdx, Genomic Prostate
Score, GPS and Monitor mdx are trademarks or registered trademarks
of MDxHealth SA. The GPS test was formerly known as and is
frequently referenced in guidelines, coverage policies,
reimbursement decisions, manuscripts and other literature as
Oncotype DX Prostate, Oncotype DX GPS, Oncotype DX Genomic Prostate
Score, and Oncotype Dx Prostate Cancer Assay, among others. The
Oncotype DX trademark, and all other trademarks and service marks,
are the property of their respective owners.
|
MDxHealth SA and Subsidiaries |
UNAUDITED CONDENSED CONSOLIDATED STATEMENT OF PROFIT OR
LOSS
|
|
|
Three Months Ended December
31, |
|
|
Year Ended December 31, |
|
|
In thousands of $ (except per share amounts) |
|
2023 |
|
|
2022 |
|
|
2023 |
|
|
2022 |
|
| |
|
|
|
|
|
|
|
|
|
|
|
|
| Revenues |
|
$ |
19,398 |
|
|
$ |
12,891 |
|
|
$ |
70,193 |
|
|
$ |
37,054 |
|
| Cost of goods &
services sold |
|
|
(6,727 |
) |
|
|
(5,667 |
) |
|
|
(26,264 |
) |
|
|
(17,835 |
) |
| Gross
profit |
|
|
12,671 |
|
|
|
7,224 |
|
|
|
43,929 |
|
|
|
19,219 |
|
| Research and
development expenses |
|
|
(1,829 |
) |
|
|
(799 |
) |
|
|
(6,376 |
) |
|
|
(5,497 |
) |
| Selling and
marketing expenses |
|
|
(9,484 |
) |
|
|
(8,467 |
) |
|
|
(36,915 |
) |
|
|
(25,704 |
) |
| General and
administrative expenses |
|
|
(6,730 |
) |
|
|
(5,746 |
) |
|
|
(23,010 |
) |
|
|
(23,308 |
) |
| Amortization of
intangible assets |
|
|
(1,127 |
) |
|
|
(1,559 |
) |
|
|
(4,494 |
) |
|
|
(3,169 |
) |
| Other operating
(expense) income, net |
|
|
193 |
|
|
|
400 |
|
|
|
(461 |
) |
|
|
559 |
|
| Operating
loss |
|
|
(6,306 |
) |
|
|
(8,947 |
) |
|
|
(27,327 |
) |
|
|
(37,900 |
) |
| Financial expenses,
net |
|
|
(4,413 |
) |
|
|
(3,363 |
) |
|
|
(15,772 |
) |
|
|
(6,144 |
) |
| Loss before
income tax |
|
|
(10,719 |
) |
|
|
(12,310 |
) |
|
|
(43,099 |
) |
|
|
(44,044 |
) |
| Income tax |
|
|
(1 |
) |
|
|
(128 |
) |
|
|
(1 |
) |
|
|
0 |
|
| Loss for
the period |
|
$ |
(10,720 |
) |
|
$ |
(12,438 |
) |
|
$ |
(43,100 |
) |
|
$ |
(44,044 |
) |
| |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Loss per
share attributable to parent |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Basic and
diluted |
|
$ |
(0.39 |
) |
|
$ |
(0.76 |
) |
|
$ |
(1.66 |
) |
|
$ |
(2.78 |
) |
UNAUDITED CONDENSED CONSOLIDATED STATEMENT OF FINANCIAL
POSITION
|
In thousands of $ |
|
|
|
December 31, 2023 |
|
|
December 31,2022 |
|
|
ASSETS |
|
|
|
|
|
|
|
|
|
Non-current assets |
|
|
|
|
|
|
|
|
| Goodwill |
|
|
|
$ |
35,926 |
|
|
$ |
35,926 |
|
| Intangible
assets |
|
|
|
|
44,337 |
|
|
|
46,166 |
|
| Property,
plant and equipment |
|
|
|
|
4,956 |
|
|
|
3,791 |
|
| Right-of-use
assets |
|
|
|
|
4,989 |
|
|
|
4,103 |
|
| Financial
assets |
|
|
|
|
763 |
|
|
|
- |
|
| Total
non-current assets |
|
|
|
|
90,971 |
|
|
|
89,986 |
|
| |
|
|
|
|
|
|
|
|
|
|
|
Current assets |
|
|
|
|
|
|
|
|
|
|
|
Inventories |
|
|
|
|
2,779 |
|
|
|
2,327 |
|
| Trade
receivables |
|
|
|
|
11,088 |
|
|
|
9,357 |
|
| Prepaid
expenses and other current assets |
|
|
|
|
1,914 |
|
|
|
1,962 |
|
| Cash and cash
equivalents |
|
|
|
|
22,380 |
|
|
|
15,503 |
|
| Total
current assets |
|
|
|
|
38,161 |
|
|
|
29,149 |
|
| TOTAL
ASSETS |
|
|
|
$ |
129,132 |
|
|
$ |
119,135 |
|
| |
|
|
|
|
|
|
|
|
|
|
|
EQUITY |
|
|
|
|
|
|
|
|
|
|
| Share
capital |
|
|
|
$ |
173,931 |
|
|
$ |
133,454 |
|
| Issuance
premium |
|
|
|
|
153,177 |
|
|
|
153,177 |
|
| Accumulated
deficit |
|
|
|
|
(331,446 |
) |
|
|
(288,346 |
) |
| Share-based
compensation |
|
|
|
|
12,139 |
|
|
|
11,474 |
|
| Translation
reserve |
|
|
|
|
(593 |
) |
|
|
(444 |
) |
| Total
equity |
|
|
|
|
7,208 |
|
|
|
9,315 |
|
| |
|
|
|
|
|
|
|
|
|
|
|
LIABILITIES |
|
|
|
|
|
|
|
|
|
|
|
Non-current liabilities |
|
|
|
|
|
|
|
|
|
|
| Loans and
borrowings |
|
|
|
|
35,564 |
|
|
|
34,914 |
|
| Lease
liabilities |
|
|
|
|
3,578 |
|
|
|
3,091 |
|
| Other
non-current financial liabilities |
|
|
|
|
63,259 |
|
|
|
53,537 |
|
| Total
non-current liabilities |
|
|
|
|
102,401 |
|
|
|
91,542 |
|
| |
|
|
|
|
|
|
|
|
|
|
|
Current liabilities |
|
|
|
|
|
|
|
|
|
|
| Loans and
borrowings |
|
|
|
|
643 |
|
|
|
616 |
|
| Lease
liabilities |
|
|
|
|
1,480 |
|
|
|
1,172 |
|
| Trade
payables |
|
|
|
|
8,811 |
|
|
|
10,178 |
|
| Other current
liabilities |
|
|
|
|
5,694 |
|
|
|
3,985 |
|
| Other current
financial liabilities |
|
|
|
|
2,895 |
|
|
|
2,327 |
|
| Total
current liabilities |
|
|
|
|
19,523 |
|
|
|
18,278 |
|
| Total
liabilities |
|
|
|
|
121,924 |
|
|
|
109,820 |
|
| TOTAL
EQUITY AND LIABILITIES |
|
|
|
$ |
129,132 |
|
|
$ |
119,135 |
|
UNAUDITED CONDENSED CONSOLIDATED STATEMENT OF CASH
FLOWS
|
|
|
|
|
Year Ended December 31, |
|
|
|
In thousands of $For the years ended December
31 |
|
|
|
2023 |
|
|
2022 |
|
|
| CASH
FLOWS FROM OPERATING ACTIVITIES |
|
|
|
|
|
|
|
|
|
|
Operating loss |
|
|
|
$ |
(27,327 |
) |
|
$ |
(37,900 |
) |
|
| Depreciation and
amortization |
|
|
|
|
6,859 |
|
|
|
4,909 |
|
|
| Impairment |
|
|
|
|
- |
|
|
|
44 |
|
|
| Share-based
compensation |
|
|
|
|
665 |
|
|
|
867 |
|
|
| Other non-cash
transactions |
|
|
|
|
421 |
|
|
|
(473 |
) |
|
| Cash
used in operations before working capital changes |
|
|
|
|
(19,382 |
) |
|
|
(32,553 |
) |
|
| |
|
|
|
|
|
|
|
|
|
|
|
| Increase (-) in
inventories |
|
|
|
|
(452 |
) |
|
|
(416 |
) |
|
| Increase (-) in
receivables |
|
|
|
|
(1,683 |
) |
|
|
(5,122 |
) |
|
| Increase (+) in
payables |
|
|
|
|
20 |
|
|
|
3,973 |
|
|
| Net cash
outflow from operating activities |
|
|
|
|
(21,497 |
) |
|
|
(34,118 |
) |
|
| |
|
|
|
|
|
|
|
|
|
|
|
| CASH
FLOWS FROM INVESTING ACTIVITIES |
|
|
|
|
|
|
|
|
|
|
|
| Purchase of
property, plant and equipment |
|
|
|
|
(2,747 |
) |
|
|
(2,789 |
) |
|
| Acquisition and
generation of intangible assets |
|
|
|
|
(2,272 |
) |
|
|
(1,374 |
) |
|
| Acquisition of
Genomic Prostate Score Business |
|
|
|
|
- |
|
|
|
(25,000 |
) |
|
| Interests
received |
|
|
|
|
1,088 |
|
|
|
125 |
|
|
| Net cash
outflow from investing activities |
|
|
|
|
(3,931 |
) |
|
|
(29,038 |
) |
|
| |
|
|
|
|
|
|
|
|
|
|
|
| CASH
FLOWS FROM FINANCING ACTIVITIES |
|
|
|
|
|
|
|
|
|
|
|
| Proceeds from
issuance of shares, net of transaction costs |
|
|
|
|
39,599 |
|
|
|
- |
|
|
| Proceeds from
loan obligation |
|
|
|
|
- |
|
|
|
34,291 |
|
|
| Repayment of
loan obligation and debt extinguishment costs |
|
|
|
|
(1,659 |
) |
|
|
(10,805 |
) |
|
| Amendment fee
related to GPS asset purchase agreement |
|
|
|
|
(250 |
) |
|
|
- |
|
|
| Payment of lease
liability |
|
|
|
|
(1,610 |
) |
|
|
(1,358 |
) |
|
| Payment of
interest |
|
|
|
|
(3,610 |
) |
|
|
(1,412 |
) |
|
| Other financial
expenses |
|
|
|
|
(190 |
) |
|
|
- |
|
|
| Net cash
inflow from financing activities |
|
|
|
|
32,280 |
|
|
|
20,716 |
|
|
| |
|
|
|
|
|
|
|
|
|
|
|
| Net
increase (+) / decrease (-) in cash and cash
equivalents |
|
|
|
|
6,852 |
|
|
|
(42,440 |
) |
|
| |
|
|
|
|
|
|
|
|
|
|
|
| Cash and cash
equivalents at beginning of the financial year |
|
|
|
|
15,503 |
|
|
|
58,498 |
|
|
| Effect on
exchange rate changes |
|
|
|
|
25 |
|
|
|
(555 |
) |
|
| Cash and
cash equivalents at end of the financial year |
|
|
|
$ |
22,380 |
|
|
$ |
15,503 |
|
|
MDxHealth (NASDAQ:MDXH)
Historical Stock Chart
From Dec 2024 to Jan 2025
MDxHealth (NASDAQ:MDXH)
Historical Stock Chart
From Jan 2024 to Jan 2025
