MDxHealth SA SEC Filings

MDxHealth SA director Hilde Windels has filed an initial ownership report showing indirect holdings of share options in MDxHealth SA through Hilde Windels BV. The positions include options over 1,000 ordinary shares at €49.70 expiring on June 1, 2028 and 1,000 shares at €12.80 expiring on July 1, 2029. Additional grants cover 30,000 ordinary shares at $2.62 expiring on June 22, 2034 and 10,000 shares at $2.18 expiring on June 27, 2035. These options were granted in prior years and vest or vested in connection with annual general shareholders' meetings, and the reporting person disclaims beneficial ownership of securities held by Hilde Windels BV except to the extent of any pecuniary interest.

MDxHealth SA director Koen Hoffman filed an initial statement of beneficial ownership, detailing his existing share option holdings. He reports options over 1,000 and 2,000 ordinary shares at exercise prices of 49.70 Euros and 12.80 Euros, granted in 2018 and 2019 and already fully vested. He also reports options over 30,000 and 10,000 ordinary shares at exercise prices of $2.62 and $2.18, granted in 2024 and 2025. Part of these options are held indirectly through Ahok BV, where he owns 53.33%, and he disclaims beneficial ownership beyond his pecuniary interest.

MDxHealth presents an annual report highlighting continued losses, going concern uncertainty and reliance on key prostate cancer tests. As of December 31, 2025, the company had an accumulated deficit of $403.0 million, a 2025 net loss of $33.5 million and net cash outflows from operations of $2.2 million. Management expects further losses and notes that failure to raise capital could jeopardize its ability to continue as a going concern. A $100 million senior secured credit facility with OrbiMed, maturing in 2029, imposes revenue and liquidity covenants and is secured by substantially all assets. Revenue is concentrated in Confirm mdx and GPS mdx tests, which generated about 76% of 2025 revenue and depend heavily on Medicare and commercial reimbursement. The report also describes intense competition in molecular diagnostics, complex billing and reimbursement risk, extensive regulatory exposure, and the importance of MDxHealth’s patent portfolio and CLIA-certified laboratories.

MDxHealth SA director Michael Holder reports initial holdings of share options. The filing shows options to purchase 10,000 ordinary shares at an exercise price of $2.18 per share, granted on June 27, 2025. These options vest in full at the annual general shareholders' meeting held in the calendar year after the grant year and expire on June 27, 2035.

MVM Partners, LLC has filed an initial ownership report for MDxHealth SA, showing indirect holdings of 4,700,457 Ordinary Shares. These shares are held by private investment funds managed by MVM Partners. MVM states that it may be deemed a beneficial owner through its role as investment manager but disclaims beneficial ownership beyond any pecuniary interest.

MDxHealth reported strong growth for the year ended December 31, 2025, with revenue up 20% to $107.9 million and fourth-quarter revenue up 19% to $29.5 million. Growth was driven mainly by its urology-focused precision diagnostic tests, with tissue-based tests providing most of sales.

Full-year gross profit rose 26% to $69.6 million, and gross margin improved to 64.5% from 61.2%, helped by better fixed-cost absorption. Operating expenses increased 5% to $84.0 million, reflecting acquisition-related costs and higher headcount tied to the ExoDx business.

The company reduced its operating loss to $14.4 million from $24.7 million, and net loss narrowed 12% to $33.5 million. Adjusted EBITDA improved sharply to a loss of $1.1 million from a loss of $14.7 million, indicating progress toward profitability. Cash and cash equivalents were $29.0 million at year-end.

For 2026, MDxHealth guides revenue to $137–140 million, implying 27–30% growth, and aims to reach an adjusted EBITDA margin of 10% exiting 2026.

MDxHealth is registering up to $200,000,000 of ordinary shares on a shelf basis, allowing primary offerings from time to time, including a $50,000,000 at-the-market program under a sales agreement. A separate secondary prospectus covers 1,867,186 ordinary shares for resale, outside this $200,000,000 capacity.

The company is a commercial-stage precision diagnostics business focused on urologic cancers, with core tests ExoDx, Confirm mdx and GPS. It qualifies as both an emerging growth company and a foreign private issuer, using reduced U.S. reporting requirements.

Risk factors emphasize continued losses and liquidity pressure. As of December 31, 2024, MDxHealth had an accumulated deficit of $369.5 million, a 2024 net loss of $38.1 million and operating cash outflows of $18.5 million, and its financial statements are prepared on a going-concern basis. The company also has a senior secured credit facility of up to $100 million with OrbiMed and outstanding deferred acquisition obligations, including up to $10 million related to Exosome Diagnostics and up to $54.5 million tied to the GPS business, all of which may require substantial future cash or share payments.

MDxHealth reports on its acquisition of Exosome Diagnostics and an amended earnout arrangement for a prior GPS transaction. The company agreed to acquire Exosome Diagnostics, including the ExoDx prostate cancer test and CLIA lab, for up to $15 million, with about $5 million in stock at closing and four subsequent annual instalments of $2.5 million each, partly in cash and partly in cash or stock at MDxHealth’s discretion.

Audited 2025 financials for Exosome Diagnostics show sales of $27.3 million and a net loss of $86.5 million, driven largely by impairment charges. MDxHealth also amended the GPS acquisition earnout with Exact Sciences, rescheduling remaining payments to $15.0 million in 2026, $18.0 million in 2027 and $21.5 million in 2028, and issuing warrants for 3 million MDxHealth shares at an exercise price of $5.265 per share.