Financial Data and Key Metrics Changes - The company reported a 28% revenue growth for Q4 2024, reaching $24.7 million compared to $19.4 million in Q4 2023 [16] - Gross profit for Q4 2024 was $15.5 million, a 22% increase from $12.7 million in Q4 2023, with gross margins at 62.7% [17] - The operating loss decreased by 27% to $4.6 million, while the net loss decreased by 36% to $6.8 million [18][19] - Adjusted EBITDA improved by 68% to negative $1.4 million from negative $4.4 million in Q4 2023 [20] Business Line Data and Key Metrics Changes - Total billable volume for Q4 was approximately 24,000 tests, a 26% increase [8] - Tissue-based tests, including Confirm mdx and GPS, saw a 50% increase year-over-year, totaling almost 12,000 tests in Q4 [9] - Liquid-based tests, including Select mdx, Resolve mdx, and Germline, exceeded 12,000 tests, marking a 10% increase year-over-year [9] Market Data and Key Metrics Changes - The urology diagnostic market is expected to grow at an annual rate of 5% to 10% due to factors such as increasing prostate cancer rates and an aging population [25] - The company is positioned uniquely in the market, providing clinically actionable results after initial biopsy, which is expected to drive further growth [11] Company Strategy and Development Direction - The company aims to achieve a revenue guidance of $108 million to $110 million for 2025, maintaining a goal of 20% revenue growth [14] - The focus remains on execution and leveraging existing sales channels without expanding the sales organization [12][24] - The company emphasizes building a trusted brand in the urology market through high-quality service and customer support [26] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving positive adjusted EBITDA in the first half of 2025 [20][84] - The company is optimistic about the adoption of its tests and the overall growth trajectory, despite challenges in the diagnostic pathway for patients [12][66] - Management noted that the NCCN guidelines created confusion but did not negatively impact growth, as evidenced by accelerating test volumes [44] Other Important Information - Cash and cash equivalents as of December 31, 2024, were $46.8 million, with plans to strengthen the balance sheet through a pending draw from the OrbiMed debt facility [21] - The company has a structured plan for the Germline test, expecting it to contribute to growth in 2025, albeit conservatively [31] Q&A Session Summary Question: Contribution of Germline to 2025 growth - Management is confident that Germline will contribute to growth in 2025, following a conservative approach similar to the Resolve test [31] Question: Outlook on gross margins - Management does not provide specific guidance on gross margins but expects them to remain in the mid-60s for the next few quarters [34] Question: OpEx outlook and adjusted EBITDA - Management indicated that the growth strategy remains unchanged, with no significant changes in OpEx expected as the business begins to fund itself [40][41] Question: Impact of NCCN guidelines on business - Management noted that the NCCN guidelines created confusion but did not negatively impact growth, with strong channel checks supporting their position [44] Question: Test menu breadth and new additions - Management believes the current test menu is sufficient to meet growth objectives, with no immediate plans for new test additions in 2025 [51][54] Question: Impact of Medicare reimbursement on commercial coverage - Management reported solid growth across the test menu, with expectations for continued expansion of coverage with commercial and private payers [57] Question: Timing of Exact Sciences earn-out payments - The earn-out payments to Exact Sciences are expected to occur in Q2 each year for 2025, 2026, and 2027 [88]

[Key Highlights & CEO Commentary](index=1&type=section&id=Key%20Highlights%20%26%20CEO%20Commentary) Mdxhealth reported strong Q4 and full-year 2024 results with **28% revenue growth**, driven by robust demand for its precision diagnostics, with the CEO highlighting the company is on track for adjusted EBITDA profitability in the first half of 2025 and has strengthened its balance sheet with a new debt facility to support its 2025 business plan and an earnout obligation to Exact Sciences - CEO Michael K. McGarrity stated the company is on track to achieve **adjusted EBITDA profitability** in the first half of 2025, driven by strong adoption of its test menu and commercial team execution[2](index=2&type=chunk) - The balance sheet will be significantly strengthened by drawing the second tranche of the OrbiMed debt facility, intended to meet the 2025 earnout obligation to Exact Sciences and fund the 2025 business plan[2](index=2&type=chunk) Q4 and Full-Year 2024 Key Metrics | Metric | Q4 2024 | Q4 YoY Change | Full Year 2024 | FY YoY Change | | :--- | :--- | :--- | :--- | :--- | | Revenue (USD) | $24.7 million | +28% | $90.0 million | +28% | | Adjusted EBITDA (USD) | ($1.4) million | +68% improvement | ($14.7) million | +24% improvement | | Tissue-based Test Volume | 11,789 | +50% | N/A | N/A | | Liquid-based Test Volume | 12,036 | +10% | N/A | N/A | | Year-End Cash (USD) | N/A | N/A | $46.8 million | N/A | [Financial Performance Analysis](index=2&type=section&id=Financial%20Performance%20Analysis) Mdxhealth achieved **28% revenue growth** for both the fourth quarter and the full year of 2024, reaching **$24.7 million** and **$90.0 million**, respectively, accompanied by improved operating and net losses and a significant improvement in Adjusted EBITDA, although gross margins saw a slight decline due to test mix [Fourth Quarter 2024 Financial Results](index=2&type=section&id=Fourth%20Quarter%202024%20Financial%20Results) Q4 2024 revenue grew **28% YoY** to **$24.7 million**, primarily driven by tissue-based tests which accounted for **81% of revenue**, with gross profit increasing **22%** to **$15.5 million**, though gross margin slightly declined to **62.7%** from **65.3%** due to test mix and payment timing, and the company significantly improved its bottom line, with net loss decreasing by **36%** to **$6.8 million** and Adjusted EBITDA improving by **68%** to **($1.4) million** Q4 2024 vs Q4 2023 Financial Performance (USD in millions) | Metric | Q4 2024 | Q4 2023 | Change | | :--- | :--- | :--- | :--- | | Revenue | $24.7 | $19.4 | +28% | | Gross Profit | $15.5 | $12.7 | +22% | | Gross Margin | 62.7% | 65.3% | -2.6 p.p. | | Operating Expenses | $20.1 | $19.0 | +6% | | Net Loss | ($6.8) | ($10.7) | -36% | | Adjusted EBITDA | ($1.4) | ($4.4) | +68% improvement | - Tissue-based tests (Confirm mdx and GPS) were the primary revenue driver, accounting for **81%** of total Q4 2024 revenue[6](index=6&type=chunk) - The **6%** increase in operating expenses was primarily driven by higher R&D expenses related to clinical studies[7](index=7&type=chunk) [Full Year 2024 Financial Results](index=2&type=section&id=Full%20Year%202024%20Financial%20Results) For the full year 2024, revenue increased **28%** to **$90.0 million**, with tissue-based tests representing **80%** of the total, gross profit rose **26%** to **$55.1 million**, with a slight margin contraction to **61.2%**, operating expenses grew **12%** due to increased R&D for clinical trials and higher sales and marketing incentive compensation, net loss improved by **12%** to **$38.1 million**, and Adjusted EBITDA improved by **24%** to **($14.7) million**, with the company ending the year with a strong cash position of **$46.8 million** Full Year 2024 vs 2023 Financial Performance (USD in millions) | Metric | FY 2024 | FY 2023 | Change | | :--- | :--- | :--- | :--- | | Revenue | $90.0 | $70.2 | +28% | | Gross Profit | $55.1 | $43.9 | +26% | | Gross Margin | 61.2% | 62.6% | -1.4 p.p. | | Operating Expenses | $79.9 | $71.3 | +12% | | Net Loss | ($38.1) | ($43.1) | -12% | | Adjusted EBITDA | ($14.7) | ($19.4) | +24% improvement | - The increase in operating expenses was driven by R&D for clinical trials and higher sales and marketing expenses tied to revenue growth and incentive compensation[10](index=10&type=chunk) - Cash and cash equivalents stood at **$46.8 million** as of December 31, 2024[12](index=12&type=chunk) [2025 Outlook](index=2&type=section&id=Outlook%20for%202025) The company reaffirms its previously issued 2025 revenue guidance of **$108-110 million** and confirms its expectation to achieve adjusted EBITDA profitability in the first half of 2025 - Maintains 2025 revenue guidance of **$108-110 million**[13](index=13&type=chunk) - Expects to achieve **adjusted EBITDA profitability** in the first half of 2025[13](index=13&type=chunk) [Consolidated Financial Statements](index=5&type=section&id=Consolidated%20Financial%20Statements) This section presents the unaudited condensed consolidated financial statements for the year ended December 31, 2024, including the Statement of Profit or Loss, Statement of Financial Position, and Statement of Cash Flows, providing a detailed view of the company's financial health and performance [Unaudited Condensed Consolidated Statement of Profit or Loss](index=5&type=section&id=UNAUDITED%20CONDENSED%20CONSOLIDATED%20STATEMENT%20OF%20PROFIT%20OR%20LOSS) The statement details the company's revenues, costs, and expenses for Q4 and the full year of 2024 compared to 2023, with the company reporting revenues of **$90.0 million** and a net loss of **$38.1 million** for the full year 2024, an improvement from the **$43.1 million** net loss in 2023, and basic and diluted loss per share for FY 2024 was **($1.16)**, compared to **($1.66)** in FY 2023 Full Year 2024 vs 2023 Statement of Profit or Loss (USD in thousands) | Account | 2024 | 2023 | | :--- | :--- | :--- | | Revenues | $90,049 | $70,193 | | Gross profit | $55,141 | $43,929 | | Operating loss | $(24,722) | $(27,327) | | Loss for the period | $(38,069) | $(43,100) | | Basic and diluted loss per share | $(1.16) | $(1.66) | [Unaudited Condensed Consolidated Statement of Financial Position](index=6&type=section&id=UNAUDITED%20CONDENSED%20CONSOLIDATED%20STATEMENT%20OF%20FINANCIAL%20POSITION) The balance sheet as of December 31, 2024, shows total assets of **$157.3 million** and total liabilities of **$142.5 million**, resulting in total equity of **$14.8 million**, with cash and cash equivalents significantly increasing to **$46.8 million** from **$22.4 million** at the end of 2023, while total liabilities also grew from **$121.9 million** Statement of Financial Position Highlights (USD in thousands) | Account | Dec 31, 2024 | Dec 31, 2023 | | :--- | :--- | :--- | | **ASSETS** | | | | Cash and cash equivalents | $46,798 | $22,380 | | Total current assets | $66,895 | $38,161 | | Total non-current assets | $90,434 | $90,971 | | **TOTAL ASSETS** | **$157,329** | **$129,132** | | **EQUITY & LIABILITIES** | | | | Total equity | $14,841 | $7,208 | | Total current liabilities | $42,663 | $19,523 | | Total non-current liabilities | $99,825 | $102,401 | | **TOTAL EQUITY AND LIABILITIES** | **$157,329** | **$129,132** | [Unaudited Condensed Consolidated Statement of Cash Flows](index=7&type=section&id=UNAUDITED%20CONDENSED%20CONSOLIDATED%20STATEMENT%20OF%20CASH%20FLOWS) For the year ended December 31, 2024, net cash outflow from operating activities was **$18.5 million**, with a net cash inflow from financing activities of **$44.6 million**, largely from share issuance (**$40.7 million**) and new loan proceeds (**$53.0 million**) offset by repayments, driving a net increase in cash of **$24.4 million**, and the company ended the year with a cash balance of **$46.8 million** Statement of Cash Flows Summary (USD in thousands) | Cash Flow Activity | Year Ended Dec 31, 2024 | Year Ended Dec 31, 2023 | | :--- | :--- | :--- | | Net cash outflow from operating activities | $(18,530) | $(21,497) | | Net cash outflow from investing activities | $(1,636) | $(3,931) | | Net cash inflow from financing activities | $44,598 | $32,280 | | **Net increase in cash and cash equivalents** | **$24,432** | **$6,852** | | **Cash and cash equivalents at end of year** | **$46,798** | **$22,380** | [Non-IFRS Measures Reconciliation](index=3&type=section&id=Non-IFRS%20Measures%20Reconciliation) This section provides a reconciliation of the IFRS net loss to the non-IFRS measure, Adjusted EBITDA, which management uses to evaluate core operating performance, with the full year 2024 IFRS net loss of **$38.1 million** adjusted for items such as amortization (**$4.9 million**), depreciation (**$3.1 million**), interest expense (**$6.6 million**), and fair value adjustments (**$3.0 million**) to arrive at an Adjusted EBITDA of **($14.7) million**, a **24%** improvement over the prior year - Adjusted EBITDA is defined as net loss adjusted for interest expense, depreciation and amortization, share-based compensation, fair-value adjustments, debt extinguishment costs, and other financial and non-cash expenses[17](index=17&type=chunk) Reconciliation of IFRS Net Loss to Adjusted EBITDA (USD in thousands) | Reconciliation Item | Q4 2024 | Q4 2023 | FY 2024 | FY 2023 | | :--- | :--- | :--- | :--- | :--- | | **IFRS net loss** | **$(6,841)** | **$(10,720)** | **$(38,069)** | **$(43,100)** | | Amortization of intangible assets | $1,330 | $1,127 | $4,905 | $4,494 | | Depreciation expense | $863 | $455 | $3,134 | $2,365 | | Share-based compensation expense | $666 | $208 | $1,725 | $665 | | Interest expense, net | $1,589 | $1,064 | $6,551 | $4,494 | | Other Adjustments | $967 | $3,594 | $6,700 | $11,700 | | **Adjusted EBITDA** | **$(1,378)** | **$(4,371)** | **$(14,672)** | **$(19,382)** |

Core Insights - MDxHealth reported a strong financial performance for Q4 2024, with revenue growth of 28% to $24.7 million and a full-year revenue increase of 28% to $90.0 million [1][9] - The company achieved a 68% improvement in adjusted EBITDA for Q4, indicating progress towards profitability [8][9] - CEO Michael K. McGarrity emphasized the company's commitment to sustainable growth and the strong demand for its precision diagnostics [3] Financial Performance - Q4 2024 revenue was $24.7 million, up from $19.4 million in Q4 2023, marking a 28% increase [5][6] - Full-year revenue reached $90.0 million, compared to $70.2 million in 2023, also a 28% increase [8][9] - Gross profit for Q4 increased by 22% to $15.5 million, with gross margins at 62.7%, down from 65.3% in the prior year [6][10] - Operating expenses rose 6% to $20.1 million in Q4, driven by R&D and other operational costs [7][11] - The net loss for Q4 decreased by 36% to $6.8 million, compared to $10.7 million in Q4 2023 [7][12] Adjusted EBITDA - Adjusted EBITDA for Q4 was ($1.4) million, reflecting a 68% improvement from ($4.4) million in the same period last year [8][9] - For the full year, adjusted EBITDA was ($14.7) million, a 24% improvement compared to ($19.4) million in 2023 [12][25] Market and Product Insights - Tissue-based tests accounted for 81% of Q4 2024 revenue, up from 76% in Q4 2023 [6][8] - The volume of tissue-based tests increased by 50% year-over-year, while liquid-based tests saw a 10% increase [9] Outlook - The company maintains its 2025 revenue guidance of $108-110 million and anticipates achieving adjusted EBITDA profitability in the first half of 2025 [14]

Group 1 - MDxHealth SA will release its financial results for Q4 and full year 2024 on February 26, 2025, after market close [1][2] - The conference call will be hosted by CEO Michael K. McGarrity and CFO Ron Kalfus at 4:30 PM ET / 22:30 CET [2] - Dial-in details for the conference call are provided for various countries including the United States, Belgium, the Netherlands, and the United Kingdom [2] Group 2 - MDxHealth is a leading precision diagnostics company specializing in actionable molecular information for personalized patient diagnosis and treatment [3] - The company's tests utilize proprietary genomic, epigenetic, and other molecular technologies to assist in the diagnosis and prognosis of urologic cancers and diseases [3] - MDxHealth has its U.S. headquarters in Irvine, California, and additional laboratory operations in Plano, Texas, with European headquarters in Herstal, Belgium [3]

Company Overview - MDxHealth is a commercial-stage precision diagnostics company specializing in molecular information for personalized patient diagnosis and treatment, particularly in urologic cancers and diseases [1] - The company operates with U S headquarters in Irvine, California, and European headquarters in Herstal, Belgium, with additional laboratory operations in Plano, Texas [1] Financial Performance - The company expects Q4 2024 revenue of $24 7 million and full-year 2024 revenue of $90 0 million, representing 28% year-over-year growth for both periods [2] - For 2025, the company issued revenue guidance of $108-110 million, reflecting 20-22% year-over-year growth [3] - The company anticipates achieving adjusted EBITDA profitability in the first half of 2025 [3] Operational Metrics - In Q4 2024, the company billed 11,789 tissue-based units (50% growth) and 12,036 liquid-based units (10% growth) [2] - For the full year 2024, the company billed 41,586 tissue-based units (31% growth) and 45,700 liquid-based units (28% growth) [2] - The company ended 2024 with a cash balance of $46 8 million [2] Growth Strategy - The company attributes its growth to the strength of its sales channel and expanded menu offerings to its urology customer base [4] - Management expresses confidence in sustaining growth through operating discipline, commercial execution, and underlying market growth [4] Reporting Calendar - Key upcoming financial reporting dates include Q1 2025 results on May 14, 2025, and the annual shareholders' meeting on May 29, 2025 [5] - Additional reporting dates are scheduled for Q2 and Q3 2025 results on August 14 and November 12, respectively [5] Financial Reporting Status - The preliminary financial data for 2024 is unaudited and subject to potential material adjustments during the finalization process [9]

Financial Data and Key Metrics - Q3 2024 revenue increased by 21% YoY to $23.3 million, with an adjusted growth rate of 27% when accounting for Select revenue backlog in Q3 2023 [5][7] - Gross profit for Q3 2024 was $14.3 million, up 14% YoY, with gross margins at 61.2%, down from 64.9% in Q3 2023 due to Select Medicare backlog [25] - Operating loss for Q3 2024 was $6.1 million, compared to $4.6 million in Q3 2023, driven by clinical study expenses, GPS lab transition, and sales incentive compensation [26] - Cash and cash equivalents stood at $49.3 million as of September 30, 2024, with pro-forma cash balance reaching $53.5 million after over-allotment proceeds [10][27] Business Line Performance - Total billable test volume for Q3 2024 was 22,795, representing 30% YoY growth [8] - Tissue-based tests (Confirm mdx and GPS) volume exceeded 10,000 tests, up 36% YoY [8] - Liquid-based tests (Select mdx, Resolve mdx, and Germline) volume exceeded 12,000 tests, up 24% YoY [9] Market Performance - The company raised its 2024 revenue guidance from $85-87 million to $87-89 million, marking the third consecutive quarter of upward revision, reflecting confidence in diagnostic value and increasing healthcare provider utilization [21] - The U.S. addressable market for urology precision diagnostics is estimated at $5 billion, with the company achieving organic growth without expanding its sales organization [23] Strategic Direction and Industry Competition - The company aims to generate at least 20% YoY revenue growth over the next several years, driven by its leadership in urology precision diagnostics [6][29] - The company’s focus on molecular diagnostics in the high-growth urology market is supported by rising prostate cancer incidence, expected to grow at a 5% annual compound rate due to pandemic-related screening declines and an aging population [32][33] - The company’s Confirm test offers a 96% negative predictive value, reducing the need for repeat biopsies and detecting aggressive cancers missed by initial biopsies [16] Management Commentary on Operating Environment and Future Outlook - Management expressed confidence in achieving adjusted EBITDA positivity in the first half of 2025, supported by strong revenue growth and operating discipline [11][77] - The company’s commercial team, including molecular diagnostic sales reps and strategic account managers, is driving increased adoption among key opinion leaders and urology group practices [13] - The company’s pathway for precision diagnostics is seen as best for patients, providing clear and actionable information to physicians and patients, avoiding unnecessary interventions while accelerating treatment when appropriate [20] Other Important Information - The company raised $40 million in gross proceeds during Q3 2024, with strong institutional investor demand, bolstering its cash position to $53.5 million [10][27] - The company’s GPS test has 20-year follow-up data for adverse pathology and prostate-specific mortality, requiring five times less tissue than competing tests, which is compelling for pathologists focused on tissue preservation [18] Q&A Session Summary Question: Revenue Guidance and Q4 Expectations - The company raised its 2024 revenue guidance, with Q4 expected to see a slight step down due to seasonality and fewer business days, but management remains confident in meeting or exceeding the updated guidance [39][40] Question: Portfolio Expansion and M&A Strategy - The company has shifted from transformative M&A (e.g., GPS acquisition) to focusing on channel growth opportunities, with a disciplined approach to de-risking and ensuring clinical relevance [41][46] Question: Revenue Growth Levers for 2025 - Growth levers for 2025 include continued adoption of the company’s diagnostic menu in urology, engagement with pathology, and leveraging large urology group practices for increased utilization [49][52] Question: End Market Dynamics and Test Volume Drivers - Test volume growth is driven by market penetration, share gains, and utilization increases, with adoption becoming more sustainable as urologists and pathologists integrate the company’s tests into their practice pathways [53][57] Question: ASP Growth and Commercial Payers - The company is focused on tightening its payer mix distribution, with ongoing efforts to secure medical policies and contracts with commercial payers, leveraging its market access and managed care team [59][62] Question: Germline Test Uptake - The Germline test is expected to contribute modestly in the back half of 2024, with a more significant ramp anticipated in 2025 as payer coverage and adoption increase [63][65] Question: Doctor Utilization and Test Adoption - The company tracks utilization by individual doctors and group practices, noting that adoption has become stickier, with many urologists ordering multiple tests from the company’s menu [68][70] Question: Impact of Storms on Business - The company reported no significant impact from recent storms on its business operations [71] Question: Revenue Growth Composition for 2025 - The company expects balanced growth across its tissue-based (80% of revenue) and liquid-based tests, with Germline contributing more significantly in 2025 [73][74] Question: Gross Margin and EBITDA Positivity - The company’s path to positive EBITDA in H1 2025 is driven by revenue growth and operating discipline, with gross margins expected to trend positively but not being a primary driver of EBITDA improvement [75][78]

Exhibit 1.1 18,500,000 Ordinary Shares MDxHEALTH SA ORDINARY SHARES UNDERWRITING AGREEMENT September 25, 2024 TD Securities (USA) LLC William Blair & Company, L.L.C. As Representatives of the several Underwriters c/o TD Securities (USA) LLC 1 Vanderbilt Avenue New York, New York 10017 William Blair & Company, L.L.C. 150 N. Riverside Plaza Chicago, Illinois 60606 Ladies and Gentlemen: (a) Shelf Registration Statement. A registration statement of the Company on Form F-3 (File No. 333-268885) (including all am ...

MDxHealth Announces Pricing of Offering of Ordinary Shares IRVINE, CA, and HERSTAL, BELGIUM – September 25, 2024 (GlobeNewswire) – MDxHealth SA (NASDAQ: MDXH) ("mdxhealth" or the "Company"), a commercial-stage precision diagnostics company, today announced that it has priced a registered public offering of 20,000,000 ordinary shares of the Company without nominal value ("Ordinary Shares") in a registered public offering (the "Offering") at a price to the public of $2.00 per Ordinary Share for total gross pr ...

MDxHealth Announces Launch of Offering of Ordinary Shares IRVINE, CA, and HERSTAL, BELGIUM –September 25, 2024 (GlobeNewswire) – MDxHealth SA (NASDAQ: MDXH) ("mdxhealth" or the "Company"), a commercial-stage precision diagnostics company, announced the launch of a proposed offering of $40.0 million of ordinary shares of the Company without nominal value ("Ordinary Shares") in a registered public offering (the "Offering"). The Company also expects to grant the underwriters a 30-day option to purchase up to 1 ...

MDxHealth (NASDAQ:MDXH) just reported results for the second quarter of 2024. MDxHealth reported earnings per share of -42 cents. This was below the analyst estimate for EPS of -26 cents. The company reported revenue of $22.16 million. This was 9.59% better than the analyst estimate for revenue of $20.22 million. InvestorPlace Earnings is a project that leverages data from TradeSmith to automate coverage of quarterly earnings reports. InvestorPlace Earnings distills key takeaways including earnings per shar ...