MDxHealth Reports Q1-2024 Results and Announces Growth Capital from OrbiMed

MDxHealth Reports Q1-2024 Results and Announces Growth Capital from OrbiMed

Year-over-year Q1 revenues increase by 35% to $19.8 million
Increasing 2024 revenue guidance to $83-85 million, previously $79-81 million
Conference call with Q&A today at 08:30 AM ET / 14:30 CET

IRVINE, CA, and HERSTAL, BELGIUM – May 1, 2024 (GlobeNewswire) – MDxHealth SA (NASDAQ: MDXH) (the "Company" or "mdxhealth"), a commercial-stage precision diagnostics company, today announced its financial results for the first quarter ended March 31, 2024 and the closing of a new debt facility with OrbiMed.

Michael K. McGarrity, CEO of mdxhealth, commented: “We are pleased to report operating results that demonstrate successful execution of our growth strategy and support our outlook for delivering sustainable growth in revenues, a consistent reduction in cash burn, and adequate runway to achieve adjusted EBITDA profitability in the first half of 2025. Additionally, we have received the first clinical samples from current customers for hereditary germline testing and now expect germline testing to begin contributing to revenue in the second quarter. Based on this continued momentum in our execution and strong demand for our tests, we are increasing our 2024 revenue guidance to $83-85 million from the previous $79-81 million.

“We are excited to partner with OrbiMed in a new debt facility, which provides significant growth capital and balance sheet flexibility, and allows the Company to further support growing demand for our precision diagnostic tests. This investment also reflects the continued progress we are making in attracting leading institutional investors who recognize our Company’s unique positioning within our high growth, urology markets.”

Key Highlights:

  • First quarter revenue of $19.8 million, an increase of 35% over prior year period
  • Prostate test volume of 12,061, an increase of 16% over prior year period
  • First clinical samples received for new hereditary germline testing
  • Refinanced existing $70 million debt facility with $100 million, 5-year interest-only debt facility with OrbiMed, of which $55 million has been drawn at closing
  • Implemented $50M At-The-Market ("ATM") program to foster long-term shareholder development

Financial review for the quarter ended March 31, 2024

USD in thousands (except per share data)

Quarter Ended March 31
20242023% Change
Cost of goods(7,771)(5,985)30%
Gross Profit12,0638,71538%
Operating expenses(18,667)(17,432)7%
Operating loss(6,604)(8,717)(24%)
Net loss(8,511)(11,709)(27%)
Basic and diluted loss per share(0.31)(0.53)(42%)

Revenue increased 35% to $19.8 million compared to $14.7 million for the prior year.

Gross margins were 60.8% compared to 59.3% for the prior year, an improvement of 1.5 percentage points.

Operating expenses increased 7% to $18.7 million compared to $17.4 million for the prior year, driven primarily by scale and volume increases through our laboratories.

Net loss decreased 27% to $8.5 million compared to $11.7 million for the prior year, driven by our increases in revenues and gross profit.

Cash and cash equivalents as of March 31, 2024, were $14.5 million.

Debt Refinancing with OrbiMed

On May 1, 2024, mdxhealth closed a $100 million loan and security agreement with funds managed by OrbiMed Advisors LLC ("OrbiMed"). The Company drew down $55 million from this loan, replacing its existing $35 million debt funded by an affiliate of Innovatus Capital Partners, LLC. At the option of the Company, an additional $45 million can be drawn under the OrbiMed facility, consisting of a $25 million delayed draw term loan and a $20 million delayed draw term loan, in 2025 and 2026 respectively, subject to certain conditions. The loans are secured by substantially all assets of the Company, including intellectual property rights. Remaining proceeds of the loans will be used for working capital purposes and to fund general business requirements.

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 08:30 AM ET / 14:30 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: 1-800-717-1738

Belgium: +32 2 290 46 34

The Netherlands: +31 20 795 2682

United Kingdom: +44 800 279 7040

Conference ID: 26604


To ensure a timely connection, it is recommended that users register at least 10 minutes prior to the scheduled
start 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. For more information, visit and follow us on social media at:, and

For more information:

LifeSci Advisors (IR & PR)
US: +1 949 271 9223

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: uncertainties associated with global macroeconomic conditions; our ability to successfully and profitably market our products; the acceptance and reimbursement of our products and services by healthcare providers and payers; our ability to obtain and maintain regulatory approvals and comply with applicable regulations; 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


  Three Months Ended
March 31,
In thousands of $ (except per share amounts) 2024  2023 
Revenues 19,834  14,700 
Cost of sales (exclusive of amortization of intangible assets)  (7,771)  (5,985)
Gross profit  12,063   8,715 
Research and development expenses  (2,164)  (1,316)
Selling and marketing expenses  (10,028)  (9,099)
General and administrative expenses  (5,359)  (5,169)
Amortization of intangible assets  (1,125)  (1,124)
Other operating income (expense), net  9   (724)
Operating loss  (6,604)  (8,717)
Financial expenses, net  (1,907)  (2,992)
Loss before income tax  (8,511)  (11,709)
Income tax      
Loss for the period  $(8,511)  $(11,709)
Loss per share attributable to parent*        
Basic and diluted  $(0.31)  $(0.53)


*The company completed a share consolidation with respect to all its outstanding shares by means of a 1-for-10 reverse stock split as of November 13, 2023. All share amounts and the EPS were adjusted retroactively to reflect the reverse stock-split.


 Thousands of $   March 31,
  December 31,
Non-current assets        
Goodwill    $35,926   $35,926 
Intangible assets    43,757   44,337 
Property, plant and equipment    4,758   4,956 
Right-of-use assets    4,625   4,989 
Financial assets    693   763 
Total non-current assets    89,759   90,971 
Current assets          
Inventories    3,044   2,779 
Trade receivables    12,669   11,088 
Prepaid expenses and other current assets    1,779   1,914 
Cash and cash equivalents    14,494   22,380 
Total current assets    31,986   38,161 
TOTAL ASSETS    $121,745   $129,132 
Share capital    $173,931   $173,931 
Issuance premium    153,177   153,177 
Accumulated deficit    (339,957)  (331,446)
Share-based compensation    12,307   12,139 
Translation reserve    (431)  (593)
Total equity    (973  7,208 
Non-current liabilities          
Loans and borrowings    35,775   35,564 
Lease liabilities    3,115   3,578 
Other non-current financial liabilities    64,878   63,259 
Total non-current liabilities    103,768   102,401 
Current liabilities          
Loans and borrowings    645   643 
Lease liabilities    1,564   1,480 
Trade payables    8,759   8,811 
Other current liabilities    6,258   5,694 
Other current financial liabilities    1,724   2,895 
Total current liabilities    18,950   19,523 
Total liabilities    122,718   121,924 
TOTAL EQUITY AND LIABILITIES    $121,745   $129,132 


    Three Months Ended March 31,  
Thousands of $
For the years ended December 31
   2024  2023  
Operating loss   $ (6,604) (8,717) 
Depreciation    775   512  
Amortization of intangible assets    1,125   1,124  
Share-based compensation    168   158  
Other non-cash transactions    (1)  815  
Cash used in operations before working capital changes    (4,537)  (6,108) 
Increase (-) / decrease (+) in inventories    (265  297  
Increase (-) / decrease (+) in receivables    (1,392)  346  
Increase (+) in payables    679   1,197  
Net cash outflow from operating activities    (5,515)  (4,268) 
Purchase of property, plant and equipment    (220)  (787) 
Acquisition and generation of intangible assets    (544  (455 
Interests received    146   4  
Net cash outflow from investing activities    (618)  (1,238) 
Proceeds from issuance of shares, net of transaction costs    -   39,599  
Repayment of loan obligation    (160  (158 
Payment of lease liability    (475)  (348) 
Payment of interest    (947)  (831) 
Other financial expenses    (170)  -  
Net cash (outflow) / inflow from financing activities    (1,752  38,262  
Net decrease (-) / increase (+) in cash and cash equivalents    (7,885  32,756  
Cash and cash equivalents at beginning of period    22,380   15,503  
Effect on exchange rate changes    (1)  (5) 
Cash and cash equivalents at end of period   $ 14,494   $48,254