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6-K 1 ea0220257-6k_mdxhealth.htm REPORT OF FOREIGN PRIVATE ISSUER

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

FORM 6-K

 

REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16

UNDER THE SECURITIES EXCHANGE ACT OF 1934

 

For the month of November 2024

 

Commission File Number 001-40996

 

MDXHEALTH SA

(Translation of registrant’s name into English)

 

CAP Business Center

Zone Industrielle des Hauts-Sarts

4040 Herstal, Belgium

+32 4 257 70 21

(Address of principal executive office)

 

Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F.

 

Form 20-F ☒    Form 40-F ☐

 

 

 

 


 

MDXHEALTH SA

 

 

INCORPORATION BY REFERENCE

 

Exhibit 99.1 of this report on Form 6-K shall be deemed to be incorporated by reference into the registration statement on Form F-3 (Registration Statement No. 333-268885) of MDxHealth SA (the “Company,” “we,” “us” and “our”) (including any prospectuses forming a part of such registration statement) and to be a part thereof from the date on which this report is filed, to the extent not superseded by documents or reports subsequently filed or furnished.

 

 

 

On November 6, 2024, the Company issued a press release, a copy of which is attached hereto as Exhibit 99.2.

 

The information in the attached Exhibit 99.2 is being furnished and shall not be deemed “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that Section, nor shall it be deemed incorporated by reference in any filing made by the Company under the Securities Act of 1933, as amended, or the Exchange Act, except as otherwise set forth herein or as shall be expressly set forth by specific reference in such a filing.

 

Exhibit No.   Description of Exhibit
99.1   Financial Results for the Third Quarter and the Three- and Nine-Month Periods Ended September 30, 2024
99.2   Press Release, dated November 6, 2024

 

1


 

SIGNATURES

 

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.

 

  MDXHEALTH SA
     
Date: November 6, 2024 By: /s/ Michael McGarrity
    Name:  Michael McGarrity
    Title: Chief Executive Officer

 

 

2

 

EX-99.1 2 ea022025701ex99-1_mdxhealth.htm FINANCIAL RESULTS FOR THE THIRD QUARTER AND THE THREE- AND NINE-MONTH PERIODS ENDED SEPTEMBER 30, 2024

Exhibit 99.1

 

 

 

CONDENSED UNAUDITED CONSOLIDATED STATEMENT OF PROFIT OR LOSS

 

    Three Months Ended
September 30,
    Nine Months Ended
September 30,
 
Thousands of $ (except per share data)   2024     2023     2024     2023  
                         
Revenues     23,317       19,350       65,310       50,795  
Cost of sales (exclusive of amortization of intangible assets)     (9,042 )     (6,797 )     (25,686 )     (19,537 )
Gross Profit     14,275       12,553       39,624       31,258  
Research and development expenses     (2,697 )     (1,557 )     (7,764 )     (4,547 )
Selling and marketing expenses     (10,619 )     (9,060 )     (31,280 )     (27,431 )
General and administrative expenses     (5,735 )     (5,381 )     (16,936 )     (16,280 )
Amortization of intangible assets     (1,327 )     (1,128 )     (3,575 )     (3,367 )
Other operating income (expense), net     11       12       (183 )     (654 )
Operating loss     (6,092 )     (4,561 )     (20,114 )     (21,021 )
Financial income     197       564       1,772       1,570  
Financial expense     (4,960 )     (6,048 )     (12,552 )     (12,929 )
Loss before income tax     (10,855 )     (10,045 )     (30,894 )     (32,380 )
Income tax     (334 )     -       (334 )     -  
Loss for the period     (11,189 )     (10,045 )     (31,228 )     (32,380 )
                                 
Loss per share attributable to parent                                
Basic and diluted     (0.40 )     (0.37 )     (1.14 )     (1.27 )

 

 

 

CONDENSED UNAUDITED CONSOLIDATED STATEMENT OF FINANCIAL POSITION

 

Thousands of $  

as of

September 30,
2024

   

as of

December 31,
2023

 
ASSETS            
Goodwill     35,926       35,926  
Intangible assets     41,924       44,337  
Property, plant and equipment     4,672       4,956  
Right-of-use assets     3,870       4,989  
Financial assets     822       763  
Non-current assets     87,214       90,971  
Inventories     4,384       2,779  
Trade receivables     14,993       11,088  
Prepaid expenses and other current assets     1,545       1,914  
Cash and cash equivalents     49,272       22,380  
Current assets     70,194       38,161  
Total assets     157,408       129,132  
EQUITY                
Share capital     213,931       173,931  
Issuance premium     149,859       153,177  
Accumulated deficit     (362,674 )     (331,446 )
Share-based compensation     16,458       12,139  
Translation reserve     (580 )     (593 )
Total equity     16,994       7,208  
                 
LIABILITIES                
Loans and borrowings     50,873       35,564  
Lease liabilities     2,537       3,578  
Other non-current financial liabilities     41,463       63,259  
Non-current liabilities     94,873       102,401  
Loans and borrowings     485       643  
Lease liabilities     1,440       1,480  
Trade payables     10,385       8,811  
Other current liabilities     7,331       5,694  
Other current financial liabilities     25,900       2,895  
Current liabilities     45,541       19,523  
Total liabilities     140,414       121,924  
Total equity and liabilities     157,408       129,132  

 

2


 

CONDENSED UNAUDITED CONSOLIDATED STATEMENT OF CASH FLOWS

 

    Nine Months Ended
September 30,
 
Thousands of $   2024     2023  
CASH FLOWS FROM OPERATING ACTIVITIES            
Operating loss     (20,114 )     (21,021 )
Depreciation     2,271       1,910  
Amortization of intangible assets     3,575       3,367  
Share-based compensation     1,059       457  
Other non-cash transactions     (85 )     276  
Cash used in operations before working capital changes     (13,294 )     (15,011 )
                 
Changes in operating assets and liabilities                
Increase (-) in inventories     (1,605 )     (541 )
Increase (-) / decrease (+) in receivables     (3,536 )     1,278  
Increase (+) in payables     3,023       151  
Net cash outflow from operating activities     (15,412 )     (14,123 )
                 
CASH FLOWS FROM INVESTING ACTIVITIES                
Purchase of property, plant and equipment     (996 )     (2,399 )
Acquisition and generation of intangible assets     (971 )     (1,612 )
Interest received     560       756  
Net cash outflow from investing activities     (1,407 )     (3,255 )
                 
CASH FLOWS FROM FINANCING ACTIVITIES                
Proceeds from issuance of shares, net of transaction costs     37,206       39,599  
Proceeds from loan obligation     53,051       -  
Repayment of loan obligation, loan modification, and debt extinguishment costs     (39,929 )     (1,239 )
Payment of lease liability     (1,409 )     (1,121 )
Payment of interest     (4,899 )     (2,666 )
Other financial expense     (306 )     -  
Net cash inflow from financing activities     43,714       34,573  
                 
Net increase in cash and cash equivalents     26,895       17,195  
                 
Cash and cash equivalents at beginning of the period     22,380       15,503  
Effect of exchange rates     (3 )     16  
Cash and cash equivalents at end of the period     49,272       32,714  

 

 

3

 

EX-99.2 3 ea022025701ex99-2_mdxhealth.htm PRESS RELEASE, DATED NOVEMBER 6, 2024

Exhibit 99.2

 

 

MDxHealth Reports Results for the Third Quarter and
Nine-Month Period Ended September 30, 2024

 

Tissue-based test volumes increase by 36%, liquid-based test volumes by 24%

 

Company raises 2024 revenue guidance to $87-89 million, representing 25% growth

 

Pro-forma cash of $53.5 million

 

Conference call and webcast today at 4:30pm ET

 

IRVINE, CA – November 6, 2024 (GlobeNewswire) – MDxHealth SA (NASDAQ: MDXH) (the “Company” or “mdxhealth”), a leading precision diagnostics company, today announced its financial results for the third quarter and nine-month period ended September 30, 2024.

 

Michael K. McGarrity, CEO of mdxhealth, commented: “We generated another strong topline performance in the third quarter of 2024, with year-over-year revenue growth of 21%, or 27% when adjusted for a backlog of Select mdx revenues in Q3 of last year following the finalization of Medicare coverage. Demand for our comprehensive menu remains robust, and we have commercial and market access teams in place to drive sustainable growth. We also strengthened our balance sheet during the quarter, with participation from existing and new investors, which enables us to drive continued growth and deliver on our view of turning adjusted EBITDA positive in the first half of next year.

 

“Based on our expectation of continued execution, we are taking our 2024 revenue guidance up from $85-87 million to $87-89 million, representing 25% year-over-year revenue growth at the midpoint of our guidance. Looking forward, based on our performance, breadth of menu, and market opportunity, we expect our 2025 revenue to meet or exceed our long-term objective of 20% sustainable growth.”

 

Key highlights for the third quarter:

 

Revenue of $23.3 million, an increase of 21% over prior year period, or 27% when adjusted for a one-time backlog of Select mdx revenue in Q3 of last year following the finalization of Medicare coverage
     
Tissue-based (Confirm mdx and GPS) test volume of 10,767, an increase of 36% over prior year period
     
Liquid-based (Select mdx, Resolve mdx, Germline) test volume of 12,028, an increase of 24% over prior year period
     
Strengthened our balance sheet with gross proceeds of $40 million through an equity offering in September 2024, or $44 million on a pro-forma basis, adjusted for the October overallotment option detailed below
     
Cash and cash equivalents as of September 30, 2024, of $49.3 million, or $53.5 million on a pro-forma basis, adjusted for the October overallotment.

 

Financial review for the three and nine months ended September 30, 2024

 

USD in ’000 (except per share data) Unaudited   Three months ended September 30     Nine months ended September 30  
    2024     2023     %Change     2024     2023     %Change  
Revenue     23,317       19,350       21 %     65,310       50,795       29 %
Cost of goods     (9,042 )     (6,797 )     33 %     (25,686 )     (19,537 )     31 %
Gross Profit     14,275       12,553       14 %     39,624       31,258       27 %
Operating expenses     (20,367 )     (17,114 )     19 %     (59,738 )     (52,279 )     14 %
Operating loss     (6,092 )     (4,561 )     34 %     (20,114 )     (21,021 )     (4 )%
Net loss     (11,189 )     (10,045 )     11 %     (31,228 )     (32,380 )     (4 )%
Basic and diluted loss per share     (0.40 )     (0.37 )     8 %     (1.14 )     (1.27 )     (10 )%

 

Results for the three months ended September 30, 2024

 

Revenue increased 21% to $23.3 million compared to $19.3 million for the prior year. Revenue in the third quarter of 2024 was comprised of 80% from tissue-based tests.

 

 


 

Gross profit increased 14% to $14.3 million compared to $12.6 million for the prior year. Gross margins were 61.2% as compared to 64.9% for the prior year, a decline of 370 basis points attributed to product mix as well as a backlog of Select mdx Medicare cases that were recognized in the third quarter of last year.

 

Operating loss increased 34% to $6.1 million compared to $4.6 million for the prior year, driven by timing of clinical study expenses, GPS laboratory transition, backlog of Select mdx revenue of approximately $1 million in Q3 of last year, as well as sales incentive compensation associated with the unit and revenue growth.

 

Net loss increased 11% to $11.2 million compared to $10.0 million for the prior year, for the reasons stated above.

 

Results for the nine months ended September 30, 2024

 

Revenue increased 29% to $65.3 million compared to $50.8 million for the prior year. Revenue for the nine-month period was comprised of 80% from tissue-based tests.

 

Gross profit increased 27% to $39.6 million compared to $31.3 million for the prior year. Gross margins were 60.7% as compared to 61.5% for the prior year, a decline of 90 basis points for the same reasons noted above.

 

Operating loss decreased 4% to $20.1 million compared to $21.0 million for the prior year, driven by higher revenues.

 

Net loss decreased 4% to $31.2 million compared to $32.4 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, net loss would have been $28.1 million, a reduction of 13% versus prior year.

 

Cash and cash equivalents as of September 30, 2024, were $49.3 million, which include net proceeds of $37.8 million from the recent financing. On October 28, 2024, the underwriters of our September offering exercised their overallotment option to purchase an additional 2,209,241 shares, providing mdxhealth with an additional $4.2 million in net proceeds. This brings pro-forma September 30, 2024 cash balance to $53.5 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 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: 1-844-825-9789

 

Belgium: 0800 38 961

 

The Netherlands: 0800 94 94 506

 

United Kingdom: 0808 238 9064

 

Conference ID: 10193602

 

Webcast: https://viavid.webcasts.com/starthere.jsp?ei=1692944&tp_key=8f9b7ff5cf

 

To ensure a timely connection, it is recommended that users register at least 10 minutes prior to the scheduled start time.

 

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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. 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.

 

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CONDENSED UNAUDITED CONSOLIDATED STATEMENT OF PROFIT OR LOSS

 

    Three Months Ended
September 30,
    Nine Months Ended
September 30,
 
Thousands of $ (except per share data)   2024     2023     2024     2023  
                         
Revenues     23,317       19,350       65,310       50,795  
Cost of sales (exclusive of amortization of intangible assets)     (9,042 )     (6,797 )     (25,686 )     (19,537 )
Gross Profit     14,275       12,553       39,624       31,258  
Research and development expenses     (2,697 )     (1,557 )     (7,764 )     (4,547 )
Selling and marketing expenses     (10,619 )     (9,060 )     (31,280 )     (27,431 )
General and administrative expenses     (5,735 )     (5,381 )     (16,936 )     (16,280 )
Amortization of intangible assets     (1,327 )     (1,128 )     (3,575 )     (3,367 )
Other operating income (expense), net     11       12       (183 )     (654 )
Operating loss     (6,092 )     (4,561 )     (20,114 )     (21,021 )
Financial income     197       564       1,772       1,570  
Financial expense     (4,960 )     (6,048 )     (12,552 )     (12,929 )
Loss before income tax     (10,855 )     (10,045 )     (30,894 )     (32,380 )
Income tax     (334 )     -       (334 )     -  
Loss for the period     (11,189 )     (10,045 )     (31,228 )     (32,380 )
                                 
Loss per share attributable to parent                                
Basic and diluted     (0.40 )     (0.37 )     (1.14 )     (1.27 )

 

4


 

CONDENSED UNAUDITED CONSOLIDATED STATEMENT OF FINANCIAL POSITION

 

Thousands of $   as of
September 30,
2024
    as of
December 31,
2023
 
ASSETS            
Goodwill     35,926       35,926  
Intangible assets     41,924       44,337  
Property, plant and equipment     4,672       4,956  
Right-of-use assets     3,870       4,989  
Financial assets     822       763  
Non-current assets     87,214       90,971  
Inventories     4,384       2,779  
Trade receivables     14,993       11,088  
Prepaid expenses and other current assets     1,545       1,914  
Cash and cash equivalents     49,272       22,380  
Current assets     70,194       38,161  
Total assets     157,408       129,132  
EQUITY                
Share capital     213,931       173,931  
Issuance premium     149,859       153,177  
Accumulated deficit     (362,674 )     (331,446 )
Share-based compensation     16,458       12,139  
Translation reserve     (580 )     (593 )
Total equity     16,994       7,208  
                 
LIABILITIES                
Loans and borrowings     50,873       35,564  
Lease liabilities     2,537       3,578  
Other non-current financial liabilities     41,463       63,259  
Non-current liabilities     94,873       102,401  
Loans and borrowings     485       643  
Lease liabilities     1,440       1,480  
Trade payables     10,385       8,811  
Other current liabilities     7,331       5,694  
Other current financial liabilities     25,900       2,895  
Current liabilities     45,541       19,523  
Total liabilities     140,414       121,924  
Total equity and liabilities     157,408       129,132  

 

5


 

CONDENSED UNAUDITED CONSOLIDATED STATEMENT OF CASH FLOWS

 

    Nine Months Ended
September 30,
 
Thousands of $   2024     2023  
CASH FLOWS FROM OPERATING ACTIVITIES            
Operating loss     (20,114 )     (21,021 )
Depreciation     2,271       1,910  
Amortization of intangible assets     3,575       3,367  
Share-based compensation     1,059       457  
Other non-cash transactions     (85 )     276  
Cash used in operations before working capital changes     (13,294 )     (15,011 )
                 
Changes in operating assets and liabilities                
Increase (-) in inventories     (1,605 )     (541 )
Increase (-) / decrease (+) in receivables     (3,536 )     1,278  
Increase (+) in payables     3,023       151  
Net cash outflow from operating activities     (15,412 )     (14,123 )
                 
CASH FLOWS FROM INVESTING ACTIVITIES                
Purchase of property, plant and equipment     (996 )     (2,399 )
Acquisition and generation of intangible assets     (971 )     (1,612 )
Interest received     560       756  
Net cash outflow from investing activities     (1,407 )     (3,255 )
                 
CASH FLOWS FROM FINANCING ACTIVITIES                
Proceeds from issuance of shares, net of transaction costs     37,206       39,599  
Proceeds from loan obligation     53,051       -  
Repayment of loan obligation, loan modification, and debt extinguishment costs     (39,929 )     (1,239 )
Payment of lease liability     (1,409 )     (1,121 )
Payment of interest     (4,899 )     (2,666 )
Other financial expense     (306 )     -  
Net cash inflow from financing activities     43,714       34,573  
                 
Net increase in cash and cash equivalents     26,895       17,195  
                 
Cash and cash equivalents at beginning of the period     22,380       15,503  
Effect of exchange rates     (3 )     16  
Cash and cash equivalents at end of the period     49,272       32,714  

 

 

6