Mdxhealth Highlights Data from Oxford’s ProMPT Study Demonstrating the Genomic Prostate Score GPS Test Predicts Adverse Outcomes Across Multiple Treatment Settings at EAU 2026 IRVINE, California – March 16, 2026 (GlobeNewswire) – Mdxhealth SA (NASDAQ: MDXH) (the "Company" or "mdxhealth"), a leader in urology-focused precision diagnostics, today announced that new data demonstrating the prognostic value of the Genomic Prostate Score (GPS mdx) test across multiple treatment strategies were presented on March ...

Mdxhealth Highlights Data from Oxford’s ProMPT Study Demonstrating the Genomic Prostate Score GPS Test Predicts Adverse Outcomes Across Multiple Treatment Settings at EAU 2026 IRVINE, California – March 16, 2026 (GlobeNewswire) – Mdxhealth SA (NASDAQ: MDXH) (the "Company" or "mdxhealth"), a leader in urology-focused precision diagnostics, today announced that new data demonstrating the prognostic value of the Genomic Prostate Score (GPS mdx) test across multiple treatment strategies were presented on March ...

Financial Data and Key Metrics Changes - The reported revenue for Q4 2025 was $29.5 million, a 19% increase from $24.7 million in Q4 2024 [10] - Gross profit for Q4 2025 was $18.7 million, up 20% from $15.5 million in Q4 2024, with gross margins increasing to 63.2% from 62.7% [11] - The operating loss for Q4 2025 increased by 14% to $5.3 million compared to $4.6 million in Q4 2024 [11] - Net loss rose 31% to $8.9 million from $6.8 million in the prior year, driven by increased financial expenses [12] - Adjusted EBITDA for Q4 was -$2.1 million, compared to -$1.4 million in Q4 2024 [12] - Cash and cash equivalents as of December 31, 2025, were $29 million [12] Business Line Data and Key Metrics Changes - Total billable volume in Q4 was approximately 38,000 tests, with tissue-based tests decreasing by 5% and liquid-based tests increasing by 128% year-over-year [10] - The acquisition of ExoDx contributed to the growth in liquid-based tests, which include Select mdx, Resolve mdx, and ExoDx [10][34] Market Data and Key Metrics Changes - The company aims to balance revenue contributions from tissue and liquid tests, which previously saw tissue tests accounting for 85% of revenue [34] - The integration of ExoDx is expected to enhance the customer base and drive growth in both segments [34] Company Strategy and Development Direction - MDxHealth's strategy focuses on menu expansion, operational discipline, and customer experience, which are expected to drive sustained top-line growth [4][6] - The company is committed to integrating ExoDx and enhancing its sales organization to capitalize on the combined customer base [34] - The goal for 2026 is to achieve revenue guidance of $137 million to $140 million, reflecting a 28% year-over-year growth [34] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's ability to deliver growth and profitability, emphasizing the importance of operational discipline and customer experience [3][14] - The integration of ExoDx is seen as a significant growth opportunity, with expectations for improved operational efficiencies and market leadership in prostate cancer diagnostics [6][16] Other Important Information - The company amended its earn-out payment to Exact Sciences, reducing the upcoming payment by nearly $20 million, providing additional financial flexibility [8] - The collaboration with the University of Oxford is expected to enhance the utility of the GPS test in clinical guidelines, further solidifying MDxHealth's market position [16] Q&A Session Summary Question: Tissue ASP decline and mix shift - Management confirmed that the decline in tissue ASP was due to a mix shift towards Confirm and noted that ASPs reflect Medicare rates [19] Question: EBITDA performance and cash flow - Management acknowledged the lower EBITDA and higher cash burn, attributing it to the integration of ExoDx and expressed confidence in achieving a 10% EBITDA margin by year-end [20][21] Question: 2026 revenue guidance assumptions - Management indicated that the guidance reflects balanced growth from both tissue and liquid segments, with significant contributions expected from the ExoDx acquisition [32][34] Question: Operating leverage and gross margin expectations - Management stated that they expect to maintain flat OpEx while achieving growth and indicated that gross margins are expected to remain in the low 60s, with aspirations for improvement [44][46]

Financial Data and Key Metrics Changes - The reported revenue for Q4 2025 was $29.5 million, a 19% increase from $24.7 million in Q4 2024 [17] - Gross profit for Q4 2025 was $18.7 million, up 20% from $15.5 million in Q4 2024, with gross margins increasing to 63.2% from 62.7% [18] - The operating loss for Q4 2025 increased by 14% to $5.3 million compared to $4.6 million in Q4 2024 [18] - The net loss for Q4 2025 rose by 31% to $8.9 million from $6.8 million in the prior year [19] - Adjusted EBITDA for Q4 was -$2.1 million, compared to -$1.4 million in Q4 2024 [19] - Cash and cash equivalents as of December 31, 2025, were $29 million [19] Business Line Data and Key Metrics Changes - Total billable volume in Q4 was approximately 38,000 tests, with tissue-based tests at 11,000 and liquid-based tests at 27,000, representing a total unit growth of 62% year-over-year [16] - Tissue-based test volumes decreased by 5% year-over-year, while liquid-based test volumes increased by 128% [17] Market Data and Key Metrics Changes - The acquisition of ExoDx is expected to significantly contribute to revenue growth, with an anticipated contribution of $20 million or more in 2026 [45] - The company aims to balance revenue growth between tissue and liquid tests, which previously saw tissue tests account for 85% of revenue [45] Company Strategy and Development Direction - MDxHealth is focused on three core operating principles: focus, execution, and growth, which have positioned the company as a leader in precision diagnostics in urology [4][9] - The company is committed to improving the customer experience, achieving a turnaround time of five days or less for critical tissue-based patient samples [8] - The integration of the ExoDx business is expected to enhance operational efficiencies and drive growth [10] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving sustained top-line growth while advancing operating profitability, with a target of reaching a 10% EBITDA margin by the end of 2026 [14][20] - The company anticipates some operational challenges in Q4 and Q1 due to the integration of the ExoDx acquisition but expects significant growth opportunities thereafter [32] Other Important Information - The company amended the Exact Sciences earn-out from the GPS acquisition, reducing the upcoming payment by nearly $20 million and deferring the full earn-out amount by an additional year [13] - The collaboration with the University of Oxford is expected to enhance the utility of the GPS test in clinical guidelines, positioning MDxHealth as a leader in risk stratification for prostate cancer [24][25] Q&A Session Summary Question: Tissue ASP decline - The decline in tissue ASP was attributed to a mix shift towards Confirm tests, with no significant issues related to denial rates [30] Question: EBITDA and cash flow concerns - Management acknowledged the lower-than-expected EBITDA and higher cash burn, attributing it to the integration of ExoDx and expressed confidence in future cash flow improvements [31][32] Question: 2026 revenue guidance assumptions - The guidance for 2026 implies 28% growth, driven by core volume growth and contributions from ExoDx, with a focus on balancing growth across tissue and liquid tests [43][45] Question: Operating leverage and gross margin - Management indicated confidence in maintaining flat OpEx while achieving growth, with gross margins expected to remain in the low 60s, aiming for improvements over time [56][60]

Financial Data and Key Metrics Changes - The reported revenue for Q4 2025 was $29.5 million, a 19% increase from $24.7 million in Q4 2024 [11] - Gross profit for Q4 2025 was $18.7 million, up 20% from $15.5 million in Q4 2024, with gross margins increasing to 63.2% from 62.7% [12] - The operating loss for Q4 2025 increased by 14% to $5.3 million compared to $4.6 million in Q4 2024 [12] - The net loss for Q4 2025 rose 31% to $8.9 million from $6.8 million in the prior year [13] - Adjusted EBITDA for Q4 was -$2.1 million, compared to -$1.4 million in Q4 2024 [13] - Cash and cash equivalents as of December 31, 2025, were $29 million [13] Business Line Data and Key Metrics Changes - Total billable volume in Q4 was approximately 38,000 tests, with tissue-based tests decreasing by 5% and liquid-based tests increasing by 128% year-over-year [11] - The acquisition of ExoDx contributed to the growth in liquid-based tests, which include Select mdx, Resolve mdx, and ExoDx [11][36] Market Data and Key Metrics Changes - The company is focused on the urology market, aiming to balance growth between tissue and liquid biopsy products [4][34] - The integration of ExoDx is expected to enhance the company's market position and customer base [36] Company Strategy and Development Direction - MDxHealth's strategy emphasizes focus, execution, and growth, with a commitment to operational discipline and customer experience [3][14] - The company aims to achieve sustained top-line growth while advancing operating profitability, targeting a 10% EBITDA margin by the end of 2026 [9][14] - The integration of ExoDx is a key part of the growth strategy, aimed at enhancing the product offering and customer base [36] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's ability to deliver growth, citing a disciplined approach to capital allocation and a commitment to patient and customer experience [14][18] - The company anticipates continued growth driven by the integration of ExoDx and the expansion of its diagnostic menu [36][40] Other Important Information - The company amended the Exact Sciences earn-out, reducing the upcoming payment by nearly $20 million and deferring the full amount by an additional year [9] - The collaboration with the University of Oxford is expected to enhance the company's reputation and position in the market [17] Q&A Session Summary Question: Tissue ASP decline and mix shift - Management confirmed that the decline in tissue ASP was due to a mix shift towards Confirm, with ASPs reflecting Medicare rates [20] Question: EBITDA and cash flow concerns - Management acknowledged the lower EBITDA and higher cash flow use, attributing it to the integration of ExoDx and expressed confidence in achieving a 10% EBITDA margin [21][24] Question: 2026 revenue guidance assumptions - Management indicated that the 2026 revenue guidance reflects balanced growth across tissue and liquid products, with expectations of $20 million contribution from ExoDx [35][36] Question: Operating leverage and gross margin expectations - Management stated that they expect to maintain flat OpEx while achieving growth, with gross margins anticipated to remain in the low 60s [44][48]

Core Insights - MDxHealth reported a fourth quarter revenue growth of 19% to $29.5 million and a full-year revenue growth of 20% to $107.9 million, indicating strong commercial execution and operational discipline [1][2][6] - The company anticipates further acceleration in growth for 2026, projecting revenue between $137 million and $140 million, representing a growth rate of 27% to 30% [3][12] Financial Performance - Fourth quarter revenue increased by 19% to $29.5 million compared to $24.7 million in the prior year, with tissue-based tests contributing 59% of total revenue [5][6] - Gross profit for the fourth quarter rose 20% to $18.7 million, with gross margins improving to 63.2% from 62.7% year-over-year [5][9] - Operating expenses increased by 19% to $23.9 million, primarily due to headcount increases and costs related to the ExoDx acquisition [7][10] - The net loss for the fourth quarter was $8.9 million, a 31% increase from $6.8 million in the previous year [7][10] - Adjusted EBITDA for the fourth quarter was ($2.1) million, reflecting a 53% increase compared to ($1.4) million in the same period last year [8][11] Year-End Summary - For the full year 2025, revenue reached $107.9 million, a 20% increase from $90.0 million in 2024, with tissue-based tests accounting for 76% of total revenue [8][10] - Gross profit for the year increased by 26% to $69.6 million, with gross margins improving to 64.5% from 61.2% [9][10] - The net loss for the year decreased by 12% to $33.5 million compared to $38.1 million in 2024, driven by a significant increase in gross profit [10][11] Outlook - The company maintains its 2026 revenue guidance of $137-140 million and aims for an adjusted EBITDA margin of 10% by the end of 2026 [3][12]

Core Insights - MDxHealth SA will release its financial results for the fourth quarter and full year ended December 31, 2025, on February 26, 2026, after market close [1] - A conference call with live Q&A will be hosted on the same day at 4:30 PM ET / 22:30 CET [2] Company Overview - MDxHealth is a leading precision diagnostics company that provides actionable molecular information to personalize patient diagnosis and treatment [3] - The company's tests utilize proprietary genomic, epigenetic, exosomal, and other molecular technologies to assist in the diagnosis and prognosis of urologic cancers and diseases [3] - The U.S. headquarters and laboratory operations are located in Irvine, California, with additional labs in Waltham, Massachusetts, and Plano, Texas, while the European headquarters is in Herstal, Belgium [3]

Core Insights - MDxHealth reported preliminary revenues for Q4 and full year 2025, with Q4 revenues of approximately $30.5 million and full year revenues of $109 million, reflecting year-over-year growth of 23% and 21% respectively [2][5] - The company issued revenue guidance for 2026, projecting revenues between $137 million and $140 million, indicating a year-over-year growth of 26-28% [3][5] - MDxHealth amended earnout terms with Exact Sciences, deferring payments related to the GPS acquisition, with payments scheduled for 2026, 2027, and 2028 totaling $54.5 million [4] Financial Performance - For Q4 2025, MDxHealth billed 11,201 tissue-based units and 27,486 liquid-based units, showing year-over-year growth of (5%) and 128% respectively [2] - For the full year 2025, the company billed 49,180 tissue-based units and 71,920 liquid-based units, representing year-over-year growth of 18% and 57% respectively [2] - The cash balance at year-end 2025 was reported at $29.0 million [2] Strategic Outlook - The CEO expressed confidence in the company's growth strategy, emphasizing the strength of the sales channel and expanded offerings to the urology customer base [5] - The company anticipates achieving an adjusted EBITDA margin run rate of 10% by the end of 2026 [5]

Core Insights - Mdxhealth is collaborating with the University of Oxford to validate the Genomic Prostate Score (GPS) test in the UK ProtecT trial, which is the largest randomized clinical trial for localized prostate cancer treatment effectiveness [1][2] - The ProtecT trial has been ongoing for over two decades, tracking more than 1,500 men with localized prostate cancer, providing extensive long-term clinical outcome data [2] - The incorporation of GPS testing aims to enhance the understanding of prostate cancer progression and improve personalized treatment approaches for patients [3] Company Overview - Mdxhealth is a precision diagnostics company focused on providing molecular information to personalize patient diagnosis and treatment, particularly in prostate cancer and other urologic diseases [4] - The company operates laboratories in Irvine, California, Waltham, Massachusetts, and Plano, Texas, with its European headquarters in Herstal, Belgium [4] Research and Development - The GPS-ProtecT study builds on previous research conducted with the ProMPT cohort, validating the correlation between GPS and prostate cancer progression [3] - The study aims to leverage a comprehensive dataset to demonstrate the predictive power of GPS in a mature prospective, randomized trial setting [3]

Financial Data and Key Metrics Changes - Q3 revenue reached $27.4 million, representing an 18% increase compared to $23.3 million in Q3 2024 [6][11] - Adjusted EBITDA for Q3 was $1 million, a significant improvement from a negative $3.8 million in Q3 2024 [12] - Gross profit increased by 25% to $17.9 million, with gross margins improving to 65.2% from 61.2% in the prior year [12] - Net loss decreased by 28% to $8 million compared to $11.2 million in the previous year [12] Business Line Data and Key Metrics Changes - Total billable volume for Q3 was approximately 33,000 tests, with tissue-based tests increasing by 18% and liquid-based tests growing by 65% year-over-year [11][12] - Tissue-based tests accounted for 76% of revenues in Q3 [11] Market Data and Key Metrics Changes - The company reported a compound annual growth rate of 45% in its sales organization over the last four years, while reducing sales and marketing expenses as a percentage of revenue [4] - The integration of the Exosome Diagnostics business is expected to enhance the company's market position in precision diagnostics for urology [3][10] Company Strategy and Development Direction - The company is focused on integrating the ExoDx acquisition to optimize sales and operational efficiencies, with a strategic expansion of the sales organization from 50 to 60 direct sales representatives [7][10] - MDxHealth aims to maintain its revenue guidance of $108-$110 million for 2025, despite the decision to forgo the germline offering [10][19] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving sustained top-line growth and advancing operating profitability, following two consecutive quarters of positive adjusted EBITDA [5][14] - The company is committed to enhancing the customer experience and operational excellence, which are seen as critical to driving future growth [14][15] Other Important Information - Cash and cash equivalents as of September 30, 2025, were reported at $32 million [13] - The company is prioritizing the integration of ExoDx and expects to provide updates on progress in early 2026 [10][14] Q&A Session Summary Question: Contribution of ExoDx in the quarter - Management indicated that there was no material contribution from ExoDx in Q3 due to the timing of the acquisition, but they remain confident in meeting revenue guidance [18][19] Question: Performance of GPS - GPS and ConfirmMDx tests reported an 18% growth, with management confident in maintaining this performance despite a slight slowdown in patient flow [23][24] Question: Germline test strategy - The company decided to forgo the germline test for now, focusing resources on the ExoDx integration, but plans to reevaluate the opportunity in 2026 [10][56] Question: Gross margins and ExoDx impact - Management expects ExoDx to be neutral to accretive to gross margins, with a clearer view anticipated after a couple of quarters of integration [59][60] Question: Sales team expansion - The sales team was expanded by adding 10 reps from ExoDx, with territory adjustments made to optimize coverage [67][68]