Providing actionable molecular diagnostic information to personalize the diagnosis and treatment of cancer

Annual Report 2020

About

MDxHealth is a commercial-stage, innovative 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.

MDxHealth continues to capitalize on the critical global trends in healthcare: the ever-growing need for early detection coupled with the need for cost-effective solutions for diagnosing, monitoring and treating cancer. Our suite of commercial products addresses these unmet needs in a market which is currently estimated at $4.2 billion and is expected to grow by 7% to $4.6 billion in 2022.

The Company's European headquarters are in Herstal, Belgium, with laboratory operations in Nijmegen, The Netherlands, and US headquarters and laboratory operations in Irvine, California. MDxHealth is listed on the Euronext Brussels stock exchange (Ticker symbol MDXH.BR).

Visit mdxhealth.comand follow us on social media at: twitter.com/mdxhealth, facebook.com/ mdxhealth and linkedin.com/company/mdxhealth.

For more information: info@mdxhealth.com

Belgium Office

US Offices and Laboratory

EU Laboratory

CAP Business Center

15279 Alton Parkway

NovioTech Campus

Rue d'Abhooz, 31

Suite 100

Transistorweg 5

4040 Herstal

Irvine, CA 92618

6534 AT Nijmegen

BELGIUM

USA

THE NETHERLANDS

Part I: Strategy & Business Review

Contents

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

4

Part I: Strategy & Business Review......................................................................................

5

Key figures...........................................................................................................................

6

Share facts...........................................................................................................................

7

2020 Business review..........................................................................................................

8

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

12

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

17

Executive management .....................................................................................................

27

Dealing Code .....................................................................................................................

31

Statutory auditor ................................................................................................................

42

Remuneration report..........................................................................................................

43

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

56

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

76

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

77

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

124

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

131

Part V: Additional information...........................................................................................

136

Shareholder information .......................................................................................................

136

Glossary ...............................................................................................................................

147

3

Annual Report 2020

Letter to shareholders

Message from the CEO

Dear Shareholders,

While 2020 was an historic year for all of us around the globe due to the COVID pandemic, I believe it is also what will turn out to be an historic year for MDxHealth and all its stakeholders. While our business was significantly impacted by the global pandemic and our results reflected the challenge in the U.S. market, in particular with prostate cancer screenings down almost 50% in 2020, we view 2020 as a pivotal year for the company for a number of very positive reasons.

It is important to note the following developments for MDxHealth in 2020, 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:

  • Our menu of SelectMDx and ConfirmMDx continued to be adopted by our urology customer base in 2020, and while our volumes were impacted by the pandemic, our customer base remains intact, and we are very confident that return of patient flow into the system will reflect this engagement.
  • On the commercial side, our sales team also remained highly engaged with our focus on driving sustainable adoption of our clinical diagnostic pathway that provides best in class actionable results for the diagnosis and treatment of prostate cancer.
  • We secured support for our growth initiatives from the first significant U.S.-managed investment into the company by MVM Partners, representing the highest quality healthcare investors in the life sciences market. This support coupled with continued support from our Reference shareholders, Valiance and Biovest in Europe, served as the foundation for additional support and investment from both EU and US investors in January of 2021.
  • Our SelectMDx test was included in July 2020 in the gold standard National Comprehensive Cancer Network (NCCN) Guidelines, and we have visibility to coverage for our SelectMDx test by Medicare and commercial payers.
  • In addition, we communicated in 2020 our intention 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.

  • Finally, we have initiated and instituted an operating discipline across the organization that will drive and leverage capital allocation and sustainable execution.

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, while improving healthcare economics by optimizing 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 to drive momentum and market share. We will now focus on expanding our menu to potentially extend our best-in-class offering into active surveillance.

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

Respectfully,

Belgium April 14, 2021

Michael K. McGarrity

Chief Executive Officer

Annual Report 2020

4

Part I: Strategy & Business Review

Business Review

5

Annual Report 2020

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Disclaimer

MDxHealth SA published this content on 23 April 2021 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 27 April 2021 09:12:02 UTC.