MDxHealth Reports Q2 and Half Year 2024
Results
Year-over-year Q2 revenues increase by 32% to
$22.2 millionYear-over-year H1 revenues increase by 34% to 42.0
millionConference call with Q&A today at 4:30 PM ET / 22:30
CET
IRVINE, CA, and HERSTAL,
BELGIUM – August 21, 2024 (GlobeNewswire) – MDxHealth SA
(NASDAQ: MDXH) (the "Company" or "mdxhealth"), a commercial-stage
precision diagnostics company, today announced its financial
results for the second quarter and half year ended June 30,
2024.
Michael K. McGarrity, CEO of mdxhealth,
commented: “Our strong topline growth of 32% for the
second quarter reflects our commercial team’s execution even
against our strongest quarter of 2023 for both units and revenue,
as well as robust demand for our precision diagnostics in our end
urology markets. We continue to see strength in both adoption and
pricing for both the Confirm and GPS tests, which will drive
sustainable growth as we go forward. As we have commented and
reported, the breadth and opportunity associated with our
significantly expanded menu and market opportunity provides clear
visibility to continued revenue growth set to our standard of 20%
or greater.”
Key Highlights for the second
quarter:
- Revenue of $22.2
million, an increase of 32% over prior year period
- Tissue-based
(Confirm mdx and GPS) test volume of 10,050, an increase of 15%
over prior year period
- Liquid-based
(Select mdx and Resolve mdx) test volume of 11,047, an increase of
35% over prior year period
Financial review for the three and six
months ended June 30, 2024
USD in ‘000 (except per share
data)Unaudited |
|
Three months ended June 30 |
|
Six months ended June 30 |
|
2024 |
2023 |
% Change |
|
2024 |
2023 |
% Change |
Revenue |
|
22,159 |
16,745 |
32% |
|
41,993 |
31,445 |
34% |
Cost of sales (exclusive of amortization of intangible assets) |
|
(8,873) |
(6,755) |
31% |
|
(16,644) |
(12,740) |
31% |
Gross Profit |
|
13,286 |
9,990 |
33% |
|
25,349 |
18,705 |
36% |
Operating expenses |
|
(20,704) |
(17,733) |
17% |
|
(39,371) |
(35,165) |
12% |
Operating loss |
|
(7,418) |
(7,743) |
(4%) |
|
(14,022) |
(16,460) |
(15%) |
Net loss |
|
(11,528) |
(10,626) |
8% |
|
(20,039) |
(22,335) |
(10%) |
Basic and diluted loss per share |
|
(0.42) |
(0.39) |
8% |
|
(0.73) |
(0.91) |
(20%) |
Results for the three months ended June
30, 2024Revenue increased 32% to $22.2 million compared to
$16.7 million for the prior year. The revenue in the second quarter
of 2024 was comprised of 81% from tissue-based tests.
Gross profit increased 33% to $13.3 million
compared to $10.0 million for the prior year. Gross margins were
60.0% as compared to 59.7% for the prior year, an improvement of 30
basis points.
Operating loss decreased 4% to $7.4 million
compared to $7.7 million for the prior year, driven by higher
revenues and gross profit.
Net loss increased 8% to $11.5 million compared
to $10.6 million for the prior year, driven by an increase in net
financial expenses as the result of refinancing the Innovatus debt
with the new OrbiMed facility, which included one-time debt
extinguishment costs of $3.1 million. Excluding the debt
extinguishment costs, our net loss would have been $8.4 million, a
reduction of 21% from the second quarter of last year.
Results for the six months ended June
30, 2024 Revenue increased 34% to $42.0 million compared
to $31.4 million for the prior year. Revenue in the first half of
2024 was comprised of 80% from tissue-based tests.
Gross profit increased 36% to $25.3 million
compared to $18.7 million for the prior year. Gross margins were
60.4% as compared to 59.5% for the prior year, an improvement of 90
basis points.
Operating loss decreased 15% to $14.0 million
compared to $16.5 million for the prior year, driven by higher
revenues and gross profit.
Net loss decreased 10% to $20.0 million compared
to $22.3 million for the prior year, primarily driven by the
factors mentioned above. Net loss included one-time debt
extinguishment costs of $3.1 million as a result of refinancing the
Innovatus debt with the new OrbiMed facility. Excluding the debt
extinguishment costs, our net loss would have been $16.9 million, a
reduction of 24% from the second half of last year.
Cash and cash equivalents as of June 30, 2024,
were $21.3 million.
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 ET / 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: 1-877-407-9716
Belgium: 0 800 73 904 /or/ 0 800 73 566
The Netherlands: 0 800 023 4340 /or/ 0 800 022 3580
United Kingdom: 0 800 756 3429
Conference ID: 13747618
Webcast:
https://viavid.webcasts.com/starthere.jsp?ei=1679031&tp_key=41436200eb
To ensure a timely connection, it is recommended
that users register at least 10 minutes prior to the scheduledstart
time.
About mdxhealth®
Mdxhealth 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. The Company’s U.S. headquarters and laboratory operations
are in Irvine, California, with additional laboratory operations in
Plano, Texas. European headquarters are in Herstal, Belgium, with
laboratory operations in Nijmegen, The Netherlands. 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; 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; our ability to remain in compliance with
financial covenants made to and make scheduled payments to our
creditors; 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.
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.
CONDENSED UNAUDITED CONSOLIDATED
STATEMENT OF PROFIT OR LOSS
|
Three Months EndedJune 30, |
|
Six Months EndedJune 30, |
Thousands of $ (except per share
data) |
2024 |
|
2023 |
|
2024 |
|
2023 |
|
|
|
|
|
|
|
|
Revenues |
22,159 |
|
16,745 |
|
41,993 |
|
31,445 |
Cost of sales
(exclusive of amortization of intangible assets) |
(8,873) |
|
(6,755) |
|
(16,644) |
|
(12,740) |
Gross Profit |
13,286 |
|
9,990 |
|
25,349 |
|
18,705 |
Research and
development expenses |
(2,903) |
|
(1,674) |
|
(5,067) |
|
(2,990) |
Selling and
marketing expenses |
(10,633) |
|
(9,272) |
|
(20,661) |
|
(18,371) |
General and
administrative expenses |
(5,842) |
|
(5,730) |
|
(11,201) |
|
(10,899) |
Amortization
of intangible assets |
(1,123) |
|
(1,115) |
|
(2,248) |
|
(2,239) |
Other
operating income (expense), net |
(203) |
|
58 |
|
(194) |
|
(666) |
Operating loss |
(20,704) |
|
(17,733) |
|
(14,022) |
|
(16,460) |
Financial income |
341 |
|
332 |
|
1,642 |
|
1,006 |
Financial expense |
(4,451) |
|
(3,215) |
|
(7,659) |
|
(6,881) |
Loss before income tax |
(11,528) |
|
(10,626) |
|
(20,039) |
|
(22,335) |
Income
tax |
0 |
|
0 |
|
0 |
|
0 |
Loss for the period |
(11,528) |
|
(10,626) |
|
(20,039) |
|
(22,335) |
|
|
|
|
|
|
|
|
Loss
per share attributable to parent |
|
|
|
|
|
|
|
Basic and
diluted |
(0.42) |
|
(0.39) |
|
(0.73) |
|
(0.91) |
|
|
|
|
|
|
|
|
CONDENSED UNAUDITED CONSOLIDATED STATEMENT OF FINANCIAL
POSITION
Thousands of $ |
|
as ofJune 30, 2024 |
|
as ofDecember 31, 2023 |
ASSETS |
|
|
|
|
Goodwill |
|
35,926 |
|
35,926 |
Intangible
assets |
|
43,254 |
|
44,337 |
Property,
plant and equipment |
|
4,887 |
|
4,956 |
Right-of-use
assets |
|
4,623 |
|
4,989 |
Financial
assets |
|
1,269 |
|
763 |
Non-current assets |
|
89,959 |
|
90,971 |
Inventories |
|
3,754 |
|
2,779 |
Trade
receivables |
|
13,454 |
|
11,088 |
Prepaid
expenses and other current assets |
|
2,347 |
|
1,914 |
Cash and cash
equivalents |
|
21,344 |
|
22,380 |
Current assets |
|
40,899 |
|
38,161 |
Total assets |
|
130,858 |
|
129,132 |
EQUITY |
|
|
|
Share
capital |
|
173,931 |
173,931 |
Issuance
premium |
|
153,177 |
153,177 |
Accumulated
deficit |
|
(351,485) |
(331,446) |
Share-based
compensation |
|
16,093 |
12,139 |
Translation
reserve |
|
(528) |
(593) |
Total equity |
|
(8,812) |
7,208 |
|
|
|
|
LIABILITIES |
|
|
|
Loans and
borrowings |
|
51,312 |
35,564 |
Lease
liabilities |
|
3,095 |
3,578 |
Other
non-current financial liabilities |
|
40,251 |
63,259 |
Non-current liabilities |
|
94,658 |
102,401 |
Loans and
borrowings |
|
646 |
643 |
Lease
liabilities |
|
1,609 |
1,480 |
Trade
payables |
|
12,126 |
8,811 |
Other current
liabilities |
|
5,734 |
5,694 |
Other current
financial liabilities |
|
24,897 |
2,895 |
Current liabilities |
|
45,012 |
19,523 |
Total liabilities |
|
139,670 |
121,924 |
Total equity and liabilities |
|
130,858 |
129,132 |
CONDENSED UNAUDITED CONSOLIDATED STATEMENT OF CASH
FLOWS
|
|
Six Months Ended June 30, |
Thousands of $ |
|
2024 |
2023 |
CASH FLOWS FROM OPERATING ACTIVITIES |
|
|
|
Operating
loss |
|
(14,022) |
(16,460) |
Depreciation |
|
1,450 |
1,173 |
Amortization
of intangible assets |
|
2,248 |
2,239 |
Share-based
compensation |
|
694 |
278 |
Other non-cash
transactions |
|
205 |
696 |
Cash used in operations before working capital
changes |
|
(9,425) |
(12,074) |
|
|
|
|
Changes in operating assets and liabilities |
|
|
|
Increase (-)
in inventories |
|
(975) |
(347) |
Increase (-) /
decrease (+) in receivables |
|
(2,799) |
1,733 |
Increase (+)
in payables |
|
3,406 |
827 |
Net cash outflow from operating activities |
|
(9,793) |
(9,861) |
|
|
|
|
CASH
FLOWS FROM INVESTING ACTIVITIES |
|
|
|
Purchase of
property, plant and equipment |
|
(786) |
(2,153) |
Acquisition
and generation of intangible assets |
|
(971) |
(980) |
Interest
received |
|
363 |
317 |
Net cash outflow from investing activities |
|
(1,394) |
(2,816) |
|
|
|
|
CASH
FLOWS FROM FINANCING ACTIVITIES |
|
|
|
Proceeds from
issuance of shares, net of transaction costs |
|
0 |
39,599 |
Proceeds from
loan obligation |
|
53,358 |
0 |
Repayment of
loan obligation and debt extinguishment costs |
|
(39,218) |
(318) |
Payment of
lease liability |
|
(951) |
(712) |
Payment of
interest |
|
(2,888) |
(1,731) |
Other
financial expense |
|
(141) |
0 |
Net cash inflow from financing activities |
|
10,160 |
36,838 |
|
|
|
|
Net
(decrease) / increase in cash and cash equivalents |
|
(1,027) |
24,161 |
|
|
|
|
Cash
and cash equivalents at beginning of the period |
|
22,380 |
15,503 |
Effect of
exchange rates |
|
(9) |
(192) |
Cash and cash equivalents at end of the
period |
|
21,344 |
39,472 |
MDxHealth (NASDAQ:MDXH)
過去 株価チャート
から 10 2024 まで 11 2024
MDxHealth (NASDAQ:MDXH)
過去 株価チャート
から 11 2023 まで 11 2024