NEWS RELEASE   REGULATED INFORMATION                                                                                                                                                                                                            

IRVINE, CA, and HERSTAL, BELGIUM – 07:00 CEST, February 28, 2019 – MDxHealth SA (Euronext: MDXH.BR), today announced its business update and financial results for the year ended December 31, 2018 and provided its strategic outlook for 2019.


Michael McGarrity, newly appointed CEO, commented, “I am excited to join MDxHealth and lead the Company forward. Based on the clinical validity and value proposition advanced by the Company to date, I am confident that we  have a solid foundation for accelerated operational and commercial execution.

I am eager to apply my past experience in leading a disruptive clinical diagnostics business beyond initial adoption into standard of care, bringing tangible value to patients, clinicians and providers. Our path forward will require focus and execution, and I am confident the operating expense reduction put in place in Q4 2018 will support this focus without compromising execution.

Only a few days in, I am working closely with the management team to fully integrate into the business and look forward to sharing my assessment and forward vision over the next few months. We will plan to hold an investor call after Q1 Results Release and I look forward to working together to build value for all of our stakeholders including patients, clinicians and shareholders.


MDxHealth has undertaken the following key initiatives to drive operating performance from top line to and through the business.

The operating expense reductions and cash preservation initiatives include:


Territory Products  FY 2018 FY 2017 FY YoY
Volume  % billable Volume % billable % Change
US ConfirmMDx 20,300 99% 21,400 88% -5%
SelectMDx 13,700 93% 8,600 97% 60%
EU SelectMDx 5,100 54% 3,100 43% 66%
US + EU Grand total 39,100   33,100   18%

The Company saw progress in overall test volume growth with over 39,000 patients tested with SelectMDx and ConfirmMDx worldwide in 2018, up 18% from nearly 33,000 in 2017.





Business Updates

Corporate Governance


Key unaudited consolidated figures for the financial year ended December 31, 2018 (thousands of US dollars, except per share data):

(‘000) $ 2018 2017 Change Change
as a %
Revenue 28,397 40,508 (12,111) (29.9)%
Gross Profit 16,745 30,305 (13,560) (44.7)%
Operating expenses (48,843) (42,579) (6,264) (14.7)%
EBITDA (Profit/(Loss)) (29,131) (10,388) (18,743) (180.4)%
Operating profit/(loss) (EBIT) (32,098) (12,274) (19,824) (161.5)%
Net Income/(Loss) (32,450) (12,288) (20,162) (164.1)%
Earnings per share, basic ($) (0.54) (0.25) (0.29) (116.0)%

Revenue and Income
Total normalized revenue for the year ended December 31, 2018 was little changed at $28.4 million, compared to $28.4 million a year earlier. Including the one-time sale of the Company’s patents to Exact Sciences in 2017, total revenue was $28.4 million compared with $40.5 million. ConfirmMDx remained the lead product and accounted for 87% of total product and services revenue. The reduction of ConfirmMDx’s contribution to 87% in 2018 from 91% in 2017 also reflects continued strong growth of SelectMDx, both in the US and in Europe. Test volumes for SelectMDx grew by more than 61%, and accounted for 48% of global volumes. The lower price point of SelectMDx compared to ConfirmMDx and the early stage of payor adoption however limited revenue for SelectMDx to approximately $2.4 million, an increase of 30% year-on-year.

Revenue recognized on the sales of ConfirmMDx and SelectMDx represented 48% of total gross billings, a slight decrease compared to 2017, with a marginal improvement in the revenue recognition rate for ConfirmMDx being offset by the lower rate applicable to the fast-growing test volumes of SelectMDx.

The gross profit margin on products and services decreased from 64% in 2017 to 58% as a result of SelectMDx increasing as a percent of total volume and greater overhead being attributed to COGS, partially offset by continued efficiency improvements in the laboratory.

Operating expenses for 2018 of $48.8 million increased by $6.3 million compared to 2017, mainly as a result of a full year of the increased sales force in the US and the European commercial operations including commercial and laboratory staff. Total headcount stood at 186 at the end of 2018 compared to 232 a year earlier, the decrease reflects the optimization of the US organization in December 2018.

Cash Position
Cash and cash equivalents stood at $26.2 million at December 31, 2018, compared to $16.8 million at December 31, 2017. The net proceeds from new financing of $42.4 million were offset by an operational cash burn of $28.4 million, $2.4 million of unfavorable foreign exchange translation effects, and investments in tangible and intangible assets of $1.4 million. Cash collections from ConfirmMDx and SelectMDx only amounted to $26.5 million, 15% more than a year earlier.


The Company remains confident in the potential of its two complementary commercial stage products to provide urologists with a clear clinical pathway to accurately identify high-grade prostate cancer whilst minimizing the use of invasive procedures. We believe this clinical pathway, with SelectMDx  guiding cancer detection in a pre-biopsy setting and ConfirmMDx in a post-biopsy setting, will continue driving momentum and increase market share on all fronts. In the longer term, SelectMDx will continue to drive growth in the US and international markets.

The Company is positive about the outlook for the current year and believes it can achieve a higher volume of genomic testing for both ConfirmMDx and SelectMDx.

Growth in 2019 and beyond will benefit from:

2019 Reporting Calendar

About MDxHealth

MDxHealth is a multinational healthcare company that provides actionable molecular diagnostic information to personalize the diagnosis and treatment of cancer. The Company’s tests are based on proprietary genetic, epigenetic (methylation) and other molecular technologies and assist physicians with the diagnosis of urologic cancers, prognosis of recurrence risk, and prediction of response to a specific therapy. The Company’s European headquarters are in Herstal, Belgium, with laboratory operations in Nijmegen, The Netherlands, and US headquarters and laboratory operations based in Irvine, California. For more information, visit and follow us on social media at:, and

Financial Statements and Auditor Review

The Company’s statutory auditor, BDO Bedrijfsrevisoren CBVA, has confirmed that its audit procedures with respect to the Company’s consolidated financial statements, prepared in accordance with the International Financial Reporting Standards as adopted in the European Union, have been partially completed, that the procedures completed to date have not revealed any material adjustments that would have to be made to the accounting information derived from the Company’s consolidated financial information that is included in this press release.

The condensed Consolidated Statement of Comprehensive Income may be found on the Company’s website at The full Annual Report is expected to be made available to the public via the Company’s website in April 2019.

For more information:


Kurt Schmidt, Interim CFO
BE: +32 (0) 4 257 70 21

NL: +31 (0) 88 327 2727


Consilium Strategic Communications
David Daley, Chris Welsh, Jonathan Birt 
UK: +44 20 3709 5701



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. 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. 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, ConfirmMDx, SelectMDx, AssureMDx, PredictMDx and UrNCollect are trademarks or registered trademarks of MDxHealth SA. All other trademarks and service marks are the property of their respective owners.  The foregoing information on Kaiser Permanente and the General Service Administration contract awards is not intended to serve as an endorsement of MDxHealth or ConfirmMDx by Kaiser Permanente or the US Government.