Belgium

United States

Europe

Office

Office and Laboratory

Laboratory

CAP Business Center

15279 Alton Parkway

NovioTech Campus

Rue d'Abhooz 31

Suite 100

Transistorweg 5

4040 Hertsal

Irvine, CA 92618

6534 AT Nijmegen

About

MDxHealth is a commercial-stage precision diagnostics company that provides actionable molecular diagnostic information to personalize the diagnosis and treatment of prostate cancer and other urologic diseases. The Company's tests are based on proprietary genetic, epigenetic and other complex molecular technologies.

MDxHealth provides highly accurate and clinically actionable urologic solutions to inform patient diagnosis and treatment while improving healthcare economics for payers and providers.

The Company's US headquarters and laboratory operations are in Irvine, California.

The European headquarters are located in Herstal, Belgium, with laboratory operations in Nijmegen, The Netherlands. MDxHealth is listed on the NASDAQ and Euronext Brussels stock exchange under the ticker symbol MDXH.

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

Part I: Strategy & Business Review

Contents

Message from the CEO ............................................................................................................ 4

Part I: Business Review ......................................................................................................... 5

Key figures ................................................................................................................................ 6

Share facts ............................................................................................................................... 7

2021 Business review ............................................................................................................... 8

Part II: Corporate Governance ............................................................................................ 20

Board of directors .............................................................................................................. 24

Executive management ..................................................................................................... 32

Internal Control and risk management ............................................................................... 35

Shareholder information .................................................................................................... 39

Statutory auditor ................................................................................................................ 58

Remuneration report .......................................................................................................... 59

Part III: Principle Risks & Uncertainties ............................................................................. 72

Part IV: Financial Statements ............................................................................................ 108

Consolidated financial statements ................................................................................... 109

Auditor's opinion .............................................................................................................. 159

Condensed non-consolidated financial statements ......................................................... 167

Part I: StrategLyet&teBr tuosisnheasrsehRoelvdierws

Message from the CEO

Dear Shareholders,

The MDxHealth team continued to advance our growth initiatives in 2021 amidst another challenging year of effect from the global pandemic. While prostate cancer screenings, patient flow, and sales rep access were limited, we continue to make progress toward building a growth company as defined by consistent and sustainable revenue growth coupled with a clear and consistent focus on our business fundamentals.

It is important to note the following developments for MDxHealth in 2021, all of which underscore and reflect the commitment we made to focus and execution, and will serve as the basis for our success and growth going forward:

and clinically actionable diagnosis of infections of the urinary tract. We are confident that this is the first of potential growth opportunities we can explore that are consistent with our sales channel and focus, and will contribute to growth going forward.

  • • In addition, as we communicated in 2020, we intend to focus on expansion of our menu into active surveillance testing for prostate cancer patients. We are confident and believe that our menu as conceived will allow MDxHealth to be the only company in the space to take a patient from positive screen all the way through the diagnostic and therapeutic pathway of prostate cancer.

  • • Our menu of SelectMDx and ConfirmMDx continued to be adopted by our urology customer base in 2021, and while our volumes were impacted by the pandemic, our customer base remains intact, and we are confident that return of patient flow into the system will reflect this engagement.

  • • On the commercial side, our sales team remained highly engaged with our focus on driving sustainable adoption of our clinical diagnostic pathway that provides actionable results for the diagnosis and treatment of prostate cancer.

  • We secured support for our growth initiatives from our Initial Public Offering in the U.S. as MDxHealth was listed on the NASDAQ exchange under the ticker MDXH. This offering included support from high quality U.S. and European investors as well as our reference shareholders, and provides us with a strong balance sheet to execute on our growth objectives.

  • • Our SelectMDx test was issued a draft coverage decision. This is a significant development for MDXHealth as it signals coverage by Medicare in 2022 and, coupled with our inclusion in the gold standard National Comprehensive Cancer Network (NCCN) Guidelines, provides a leading indicator for continued growth in our adoption as well as growth in both revenue and gross margin.

  • • In 2021, we introduced an exciting channel opportunity with the market introduction of Urinary Tract Infection, or UTI, testing services for the rapid

Each of these, and all of these collectively, point to a restructured and focused business with a fact-based and evidence-based approach to our focus, investment of resources, and commitment to excellence. As I emphasized last year, the one factor that has not changed is our people. They have all risen to the challenge and are committed to delivering on our promise and positive path forward.

We remain confident in the potential of our unique menu to provide urologists with a clear clinical pathway to accurately identify high-grade prostate cancer and challenging complex infections while improving healthcare economics. We believe this clinical pathway, with SelectMDx guiding cancer detection in a pre-biopsy setting and ConfirmMDx in a post-biopsy setting, will continue to drive momentum and market share.

I would like to close by thanking our shareholders and employees for your continued support and restating our unwavering commitment to operating discipline and delivering value to all our stakeholders including patients, customers, employees and shareholders.

Respectfully,

Belgium, 20 April, 2022

Michael K. McGarrity Chief Executive Officer

Part I: Business Review

Business Review

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MDxHealth SA published this content on 25 April 2022 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 25 April 2022 20:29:05 UTC.