Full Press Release Details
Mdxhealth Reports Q1-2026 Results
Conference call with Q&A today at 4:30 PM
IRVINE, California - May 13, 2026
(GlobeNewswire) - Mdxhealth SA (NASDAQ:
MDXH) (the "Company" or "mdxhealth"), a leading precision diagnostics company, today announced its financial
results for the first quarter ended March 31, 2026.
Michael K. McGarrity, CEO of mdxhealth, commented:
"As we prioritized the integration of our recently acquired ExoDx business and to allow for renewed focus on our core prostate cancer
business, we have made the strategic decision to discontinue our Resolve UTI offering and laboratory operations in Plano, Texas. The Resolve
test was uniquely designed for our urology customer base to aid in the rapid diagnosis and therapy of patients presenting with often serial,
complex, multi-organism infections. Despite the urgent clinical need and medical necessity of the Resolve test, the increasingly uncertain
reimbursement landscape, fueled by an unexplained recent policy reversal by our Texas lab's Medicare administrator (Novitas), has
made the continued operation of this business line unsustainable. We believe this proactive exit allows us to focus our operating discipline
and sales force on our prostate cancer precision diagnostics, which will drive the most value for our customers, patients and stakeholders.
We are confident that the near-term impact of
this decision will augment our ability to drive sustainable growth of our prostate cancer menu, despite its associated impact on our Q1
results and 2026 guidance. We believe our renewed focus will advance market share and our ability to explore opportunities in additional
urologic cancers that align with our sales force focus and customer base.
An additional benefit of this refocus has been
to catalyze our commitment to leverage the promise of Artificial Intelligence (AI) into every aspect of our business. Earlier this year,
we initiated an AI-dedicated strategic initiative to build-out an AI data platform throughout the company. With the hundreds of thousands
of unique biopsy tissue specimens received in our laboratory, our goal is to leverage AI to improve our operating efficiency and clinical
value, as well as optimize our customer experience. With our recently announced landmark PROTECT trial, the study protocol with Oxford
University includes AI-enhanced endpoints, targeted to improve the performance and prognostic value of our GPS test. In addition, we have
initiated a collaboration with a customer-facing digital innovation company to develop AI-enhanced offerings, building on the evidence-based
clinical excellence of our tissue-based tests, thereby expanding our market opportunity in prostate and other urologic cancers.
By streamlining our operations and removing the
reimbursement volatility associated with Resolve, we are effectively resetting our growth trajectory for the remainder of the year. We
are establishing updated 2026 revenue guidance for our core cancer business, now excluding Resolve, of $110-115 million, which would represent
20-26% year-over-year growth over our 2025 core cancer business."
for the first quarter of 2026:
review for the quarter ended March 31, 2026
| USD in thousands (except per share data) | Quarter Ended March 31 | |||||||||||
| Unaudited | 2026 | 2025 | % Change | |||||||||
| Revenue | 27,386 | 24,292 | 13 | % | ||||||||
| Cost of goods | (10,772 | ) | (8,788 | ) | 23 | % | ||||||
| Gross Profit | 16,614 | 15,504 | 7 | % | ||||||||
| Operating expenses | (23,917 | ) | (20,092 | ) | 19 | % | ||||||
| Operating loss | (7,303 | ) | (4,588 | ) | 59 | % | ||||||
| Net loss | (8,867 | ) | (9,209 | ) | (4 | )% | ||||||
| Adjusted EBITDA* | (4,339 | ) | (1,331 | ) | 226 | % | ||||||
| Basic and diluted loss per share | (0.17 | ) | (0.19 | ) | (11 | )% |
Revenue increased 13% to $27.4 million compared
to $24.3 million for the prior year period. Tissue-based tests accounted for 66% and 85% of total first quarter 2026 and 2025 revenue,
Gross profit increased by 7% to $16.6 million
compared to $15.5 million for the prior year period. Gross margins were 60.7% compared to 63.8% for the prior year period, a reduction
of 3.1 percentage points, primarily attributed to our test mix.
Operating expenses increased 19% to $23.9 million
compared to $20.1 million for the prior year period, primarily driven by increases in headcount and other operating expenses related to
the ExoDx acquisition.
Net loss decreased by 4% to $8.9 million compared
to $9.2 million for the year period, primarily as a result of the increased operating expenses related to the ExoDx acquisition, offset
by lower net financial expenses.
Adjusted EBITDA was ($4.3) million, an increase
of 226% compared to ($1.3) million for the same period last year, primarily due to higher operating loss.
A reconciliation of IFRS to non-IFRS financial
measures has been provided in the tables included in this press release. An explanation of these measures is also included below under
the heading "Non-IFRS Disclosure."
Cash and cash equivalents as of March 31, 2026,
On April 15, 2026, mdxhealth made its 2025 earnout
payment to Exact Sciences in the amount of $15.0 million. After taking into account this earnout payment, our pro-forma cash balance as
of March 31, 2026, would have been $28.2 million.
On April 20, 2026, the Company received a Medicare
contractor recoupment decision from Novitas Solutions totaling approximately $10.4 million related to a retrospective review of certain
historical Resolve mdx claims. The Company strongly disagrees with the contractor's findings and is vigorously contesting the contractor's
decision on substantive and procedural grounds.
Management has evaluated the matter and concluded
that the recognition criteria for an accrual have not been met. The existence and ultimate amount of any obligation are contingent on
the outcomes of a multi-level appeals process, which are uncertain future events not wholly within the Company's control. At this time
no reliable estimate of any obligation can be made. Accordingly, the matter is accounted for as a contingent liability, and no provision
has been recorded for the first quarter ended March 31, 2026.
On May 8, 2026, the Company approved a strategic
plan to exit the Resolve mdx business, including the cessation of operations at its laboratory facility in Plano, Texas. As a result of
this decision, the Company expects to incur restructuring and other exit-related charges in connection with the wind-down. These charges
are expected to consist principally of (i) employee severance and other termination benefits, (ii) charges associated with the Plano facility
lease, including accelerated amortization of the right-of-use asset and leasehold improvements, (iii) impairment of long-lived assets
associated with the Resolve mdx business, including capitalized assets and equipment, (iv) charges relating to the disposition or termination
of vendor and supplier contracts, and (v) other exit-related costs. The amount and timing of these charges has not been finalized and
will be determined and recognized in accordance with applicable IFRS in future periods as the wind-down is executed and additional information
Michael K. McGarrity, Chief Executive Officer
and Ron Kalfus, interim 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: 1-800-245-3047
Int'l: 1-203-518-9765
Belgium: 0800 72 519
United Kingdom: 0808 101 1183
Conference ID: MDX1Q26
To ensure a timely connection, it is recommended
that users register at least 10 minutes prior to the scheduled start time.
Mdxhealth is a leading precision diagnostics company
that provides actionable molecular information to personalize patient diagnosis and treatment. The Company's tests, based on proprietary
genomic, epigenomic, exosomal and other molecular technologies, assist physicians with the diagnosis and prognosis of prostate cancer
and linkedin.com/company/mdxhealth.
In addition to the Company's financial results
determined in accordance with IFRS, the Company provides adjusted EBITDA and adjusted EBITDA margin, non-IFRS measures that the Company
determines to be useful in evaluating its operating performance. The Company defines adjusted EBITDA as net loss less interest expense,
depreciation and amortization of intangible assets, impairment, share-based compensation, fair-value adjustments, debt extinguishment
costs, provision for inventory obsolescence, reduction in force severance costs, ExoDx acquisition expenses, amendments related to the
Exact Sciences earnout, income tax benefit (expense), and other financial and non-cash expenses. The Company also presents adjusted revenue,
adjusted cost of goods, adjusted gross profit, adjusted operating expenses, adjusted operating loss, adjusted net loss, and adjusted basic
and diluted loss per share, which exclude the impact of the recently discontinued Resolve business. Management believes that presentation
of non-IFRS financial measures provides useful supplemental information to investors and facilitates the analysis of the Company's
core operating results and comparison of operating results across reporting periods. Adjusted EBITDA margin is calculated as adjusted
EBITDA divided by total revenue. The Company uses this non-IFRS financial information to establish budgets, manage the Company's
business, and set incentive and compensation arrangements. However, non-IFRS financial information is presented for supplemental information
purposes only, has limitations as an analytical tool and should not be considered in isolation or as a substitute for financial information