分组1 - MDxHealth SA reported a quarterly loss of $0.15 per share, which was worse than the Zacks Consensus Estimate of a loss of $0.13, but an improvement from a loss of $0.31 per share a year ago, indicating a surprise of -15.38% [1] - The company posted revenues of $26.61 million for the quarter ended June 2025, surpassing the Zacks Consensus Estimate by 0.02% and showing an increase from $22.16 million in the same quarter last year [2] - MDxHealth SA shares have increased by approximately 4.2% since the beginning of the year, while the S&P 500 has gained 7.6%, indicating underperformance relative to the broader market [3] 分组2 - The earnings outlook for MDxHealth SA is uncertain, with current consensus EPS estimates of -$0.11 for the coming quarter and -$0.52 for the current fiscal year, alongside expected revenues of $27.8 million and $108.5 million respectively [7] - The Zacks Industry Rank places the Medical Info Systems sector in the top 29% of over 250 Zacks industries, suggesting that companies in the top half of the rankings tend to outperform those in the bottom half by more than 2 to 1 [8] - The estimate revisions trend for MDxHealth SA was mixed prior to the earnings release, resulting in a Zacks Rank 3 (Hold), indicating that the stock is expected to perform in line with the market in the near future [6]

Core Insights - MDxHealth reported a 20% year-over-year increase in Q2 revenues, reaching $26.6 million, marking the 17th consecutive quarter of 20% or greater revenue growth [1][3][8] - The company achieved positive adjusted EBITDA of $1.4 million for Q2, a significant improvement of $6.2 million compared to the same period last year [1][12] - MDxHealth announced the acquisition of Exosome Diagnostics from Bio-Techne for $15 million, which is expected to enhance revenue growth and be accretive to adjusted EBITDA [1][4][6] Financial Performance - Q2 revenue of $26.6 million represents a 20% increase from $22.2 million in the prior year [9][10] - Gross profit increased by 32% to $17.6 million, with gross margins improving to 66% from 60% [10][12] - Operating loss decreased by 74% to $1.9 million, while net loss improved by 36% to $7.4 million compared to the prior year [8][11][12] Acquisition Details - The acquisition of Exosome Diagnostics includes the ExoDx Prostate test and is structured as $15 million total consideration, with $5 million in stock at closing and $2.5 million annually over the next four years [6][4] - The ExoDx business is anticipated to contribute over $20 million in revenue in 2026 and accelerate MDxHealth's revenue growth rate to approximately 30% [6][4] - The transaction is expected to close in September 2025, subject to customary closing conditions [6] Market Position and Strategy - MDxHealth's growth is driven by strong demand for its tissue-based tests, including GPS and Confirm mdx [3][4] - The acquisition is seen as a strategic move to expand MDxHealth's capabilities in liquid-based diagnostics for prostate cancer, enhancing its leadership in this high-growth market [4][6] - The company reaffirmed its 2025 revenue guidance of $108-110 million following the acquisition announcement [4]

Core Viewpoint - MDxHealth SA has appointed Michael Holder as the Chair of the Audit Committee, succeeding Regine Slagmulder, and announced the resignation of CFO Ron Kalfus, with Scott McMahan taking over interim CFO responsibilities [1][3][4] Group 1: Leadership Changes - Michael Holder brings over 30 years of experience in biotech, medtech, and pharma, having held multiple executive roles including CEO and CFO [2] - Ron Kalfus will continue as CFO until July 30, 2025, after which Scott McMahan will assume the role on an interim basis [3][4] Group 2: Company Background - MDxHealth is a precision diagnostics company focused on providing molecular information for personalized patient diagnosis and treatment, particularly in urologic cancers [5] - The company operates its U.S. headquarters in Irvine, California, and has additional laboratory operations in Plano, Texas, with European headquarters in Herstal, Belgium [5]

Financial Data and Key Metrics Changes - The company reported Q1 revenue growth of 22%, reaching $24.3 million compared to $19.8 million in Q1 2024, marking the sixteenth consecutive quarter of 20% or greater revenue growth [5][14][15] - Gross profit increased by 29% to $15.5 million, with gross margins rising to 63.8% from 60.8% in Q1 2024 [15][16] - The operating loss decreased by 31% to $4.6 million, while the net loss increased by 8% to $9.2 million, primarily due to non-cash fair value adjustments [16][16] Business Line Data and Key Metrics Changes - Tissue-based test volume grew by 41%, with approximately 12,600 tests conducted in Q1, representing a 41% increase year-over-year [6][10] - Liquid-based tests saw nearly 12,000 tests, an increase of 9% compared to the prior year [6] Market Data and Key Metrics Changes - The tissue-based segment accounted for 85% of Q1 revenue, driven by the growing diagnostic value of the Confirm test among urology customers [7][10] - The market opportunity for the Confirm test is estimated at $500 million, with a rising prostate cancer rate of 5% to 10% annually [10][80] Company Strategy and Development Direction - The company aims for 20% or greater revenue growth in 2025 and beyond, with a focus on operational discipline and commercial execution [5][13] - The strategy includes leveraging existing sales channels without expanding the sales organization, which has allowed for sustained revenue growth [19][19] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving positive adjusted EBITDA in Q2 2025, supported by flat operating expenses and continued revenue growth [16][67] - The company is focused on maintaining its leadership position in the high-growth urology diagnostics market, emphasizing the importance of its sales team and operational excellence [20][20] Other Important Information - Cash and cash equivalents as of March 31, 2025, were $65.7 million, with a pro forma cash balance of $37.7 million after an earnout payment [16] - The company has not seen a material impact from recent tariff developments on its financial operations [16] Q&A Session Summary Question: What factors are driving the growth in pathology adoption? - Management noted that the understanding of biopsy limitations has improved, leading to greater acceptance of the Confirm test among pathologists [24][26] Question: What are customers saying about the reasons for market share gains? - Customers appreciate the consultative approach of the sales team and the unique value proposition of the Confirm and GPS tests [28][30] Question: How did weather impact Q1 performance? - Management indicated that weather did not materially affect Q1 performance and expects continued execution in Q2 [36] Question: Can you comment on the growth of the GPS and Confirm tests? - Management reported balanced growth between GPS and Confirm, with both tests seeing increased adoption among urology customers [38][39] Question: What is the company's approach to M&A? - The company is open to growth opportunities but remains disciplined in its approach, focusing on derisking potential acquisitions [44][75] Question: How is the company performing in large urology practices? - Management indicated broad penetration within large urology practices, emphasizing the importance of service levels and differentiation [90][92]

Financial Data and Key Metrics Changes - The company reported Q1 revenue growth of 22%, increasing to $24.3 million from $19.8 million in the prior year [13][14] - Gross profit for the quarter was $15.5 million, a 29% increase compared to $12.1 million in Q1 2024, with gross margins rising to 63.8% from 60.8% [14] - The operating loss decreased by 31% to $4.6 million, while the net loss increased by 8% to $9.2 million, primarily due to non-cash fair value adjustments [14][15] - Adjusted EBITDA improved by 71% to negative $1.3 million compared to negative $4.5 million in Q1 2024, with expectations for positive adjusted EBITDA in Q2 2025 [14][15] Business Line Data and Key Metrics Changes - Tissue-based test volume grew by 41%, with approximately 12,600 tests conducted in Q1, representing a 41% increase year-over-year [5][6] - Liquid-based tests saw volumes of almost 12,000, an increase of 9% over the prior year [5] - Tissue-based tests accounted for 85% of Q1 revenue, highlighting their significance in the company's portfolio [6] Market Data and Key Metrics Changes - The market opportunity for the Confirm test is estimated at $500 million, with a growing rate of prostate cancer expected to rise by 5% to 10% annually [8][9] - The company is positioned as a leader in precision diagnostics for prostate cancer, with a focus on expanding its market share in the urology sector [11][19] Company Strategy and Development Direction - The company aims for 20% or greater revenue growth in 2025 and beyond, having achieved 16 consecutive quarters of such growth [4][12] - The strategy includes leveraging existing sales channels without significant expansion, focusing on operational discipline and commercial execution [17][18] - The company is exploring growth opportunities, including potential M&A, while maintaining a disciplined approach to risk management [42][73] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving revenue guidance of $108 million to $110 million for 2025, with a focus on sustaining growth and operational efficiency [12][66] - The company has not seen significant impacts from recent tariff developments and expects continued strong performance in Q2 [15][66] - Management emphasized the importance of maintaining a high-quality sales force and strong relationships with urologists and pathologists to drive growth [19][90] Other Important Information - The company made a $28 million earnout payment to Exact Sciences, impacting its cash balance but still maintaining a strong liquidity position with $65.7 million in cash and equivalents [15] - The company is committed to providing value to all stakeholders, including patients, customers, payers, and shareholders [19] Q&A Session Summary Question: What factors are driving the recent growth in tissue tests? - Management noted that pathology's understanding of the limitations of biopsies has improved, leading to greater adoption of the Confirm test [22][23] Question: What are customers saying about the reasons for market share gains? - Customers appreciate the consultative approach of the sales team and the unique value proposition of the tests, particularly the benefits of avoiding repeat biopsies [26][28] Question: How did weather impact Q1 performance? - Management indicated that weather did not materially affect Q1 performance and expects continued execution in Q2 [34][35] Question: What is the outlook for M&A opportunities? - The company is open to both M&A and partnerships but remains disciplined in evaluating opportunities, particularly in the urology space [42][73] Question: How is the company addressing pricing and gross margin? - Management is focused on maintaining or improving average selling prices while also reducing costs through operational efficiencies [56][58] Question: What is the penetration rate among urologists? - Management indicated broad penetration among urologists, with a focus on building strong relationships and demonstrating the value of their tests [88][90]

Core Insights - MDxHealth reported a year-over-year revenue increase of 22% to $24.3 million for Q1 2025, marking the 16th consecutive quarter of revenue growth of 20% or more [1][2][6] - The company expects to achieve adjusted EBITDA profitability in Q2 2025 and has reiterated its revenue guidance for 2025 at $108-110 million [2][9] Financial Performance - Revenue for Q1 2025 was $24.3 million, up from $19.8 million in Q1 2024, representing a 22% increase [4][6] - Gross profit increased by 29% to $15.5 million, with gross margins improving to 63.8% from 60.8% year-over-year [7][9] - Operating expenses rose by 8% to $20.1 million, primarily due to increased clinical trial expenses and stock-based compensation [7][9] - The net loss for Q1 2025 was $9.2 million, an 8% increase from $8.5 million in the prior year, largely due to non-cash fair value adjustments [8][9] - Adjusted EBITDA improved by 71% to a loss of $1.3 million compared to a loss of $4.5 million in Q1 2024 [10][23] Operational Highlights - Tissue-based tests accounted for 85% of total revenue in Q1 2025, up from 79% in Q1 2024 [6] - Test volumes for tissue-based tests increased by 41% to 12,677, while liquid-based test volumes rose by 9% to 11,530 [9] - The company ended Q1 2025 with cash and cash equivalents of $65.7 million [10][22] Subsequent Events - On April 29, 2025, MDxHealth made a $28.0 million earnout payment to Exact Sciences, which would adjust the pro-forma cash balance to $37.7 million as of March 31, 2025 [11]

[Report of the board of directors](index=1&type=section&id=1.%20Report%20of%20the%20board%20of%20directors) [Developments, results, risks and uncertainties](index=1&type=section&id=1.1%20Developments%2C%20results%2C%20risks%20and%20uncertainties) This section reviews the company's 2024 financial performance under statutory and consolidated statements, detailing a statutory profit turnaround, narrowed consolidated net loss, and major financial, operational, and regulatory risks [Management's discussion and analysis of the statutory financial statements of 2024 and 2023](index=1&type=section&id=1.1.1%20Management%27s%20discussion%20and%20analysis%20of%20the%20statutory%20financial%20statements%20of%202024%20and%202023) MDxHealth SA's statutory statements show a turnaround to a **€7.0 million** net profit in 2024 from a **€28.4 million** loss in 2023, driven by increased financial income and improved cash to **€42.8 million** Statutory Financial Performance (EUR) | Metric | 2024 | 2023 | Change | | :--- | :--- | :--- | :--- | | Revenue | €3,979,160 | €3,233,610 | +23.1% | | Operating Result | (€5,865,643) | (€7,493,015) | Loss reduced | | Net Financial Result | €13,265,152 | (€20,876,289) | Positive swing | | Net Profit / (Loss) | €7,031,447 | (€28,370,081) | Turnaround to profit | - The primary driver for the shift to net profit was a non-recurring financial gain of **€14.1 million** from the valuation of intercompany current accounts, a reversal from a **€20.2 million** charge in 2023[7](index=7&type=chunk) - Cash and cash equivalents increased to **€42.8 million** from **€18.9 million**, boosted by a capital increase and a new **$100 million** loan facility obtained by the U.S. subsidiary, which was used to repay an existing **$35 million** debt[10](index=10&type=chunk) - Despite the profit in 2024, the company has an accumulated deficit of **€196.5 million** Management justifies the going concern basis on its ability to continue operations for at least the next twelve months[13](index=13&type=chunk) [Management's discussion and analysis of the consolidated financial statements of 2024 and 2023](index=3&type=section&id=1.1.2%20Management%27s%20discussion%20and%20analysis%20of%20the%20consolidated%20financial%20statements%20of%202024%20and%202023) Consolidated IFRS statements show a 28% revenue increase to **$90.0 million** in 2024, narrowing the net loss by 12% to **$38.1 million**, supported by a new **$100 million** credit facility and **$40.7 million** from a public offering Consolidated Financial Highlights (USD) | Metric | 2024 | 2023 | Change | | :--- | :--- | :--- | :--- | | Total Revenue | $90.0 million | $70.2 million | +28% | | Cost of Sales | $34.9 million | $26.3 million | +32.7% | | Operating Expenses | $79.9 million | $71.3 million | +12% | | Net Loss | ($38.1 million) | ($43.1 million) | -12% | - Medicare was the only payer generating over 10% of revenue, totaling **$37.1 million** in 2024, up from **$27.7 million** in 2023[19](index=19&type=chunk) - The company secured a new five-year, **$100 million** senior secured credit facility with OrbiMed, drawing down an initial **$55 million** to repay its previous **$35 million** debt with Innovatus[32](index=32&type=chunk)[33](index=33&type=chunk) Balance Sheet Ratios | Ratio | 2024 | 2023 | | :--- | :--- | :--- | | Cash & cash equivalents as a % of total assets | 30% | 17% | | Solvency ratio (equity/total assets) | 9% | 6% | | Gearing ratio (Financial debt/equity) | 346% | 502% | [Information regarding major risks and uncertainties](index=8&type=section&id=1.1.3%20Information%20regarding%20major%20risks%20and%20uncertainties) The company faces major financial, operational, intellectual property, and regulatory risks, including a history of losses, dependence on key tests, intense competition, and potential changes in FDA oversight of laboratory-developed tests - **Financial Risks:** The company has a history of losses, may never achieve profitability, and may require substantial additional funding[47](index=47&type=chunk) - **Operational Risks:** Financial results are largely dependent on sales of two tests (Confirm mdx and GPS) The company also faces risks from industry competition, reliance on a limited number of suppliers, and potential IT system failures[51](index=51&type=chunk) - **Commercial & IP Risks:** The company faces uncertainties over reimbursement by third-party payors and must protect its intellectual property for its key tests to maintain its competitive position[51](index=51&type=chunk) - **Regulatory Risks:** The FDA may change its regulation of laboratory-developed tests, which could cause substantial costs and delays Failure to comply with various federal, state, and foreign regulations could lead to sanctions[54](index=54&type=chunk) [Information about important events after the closing of the financial year](index=11&type=section&id=1.2.%20Information%20about%20important%20events%20after%20the%20closing%20of%20the%20financial%20year%20and%20circumstances%20that%20could%20significantly%20influence%20the%20development%20of%20MDxHealth) The only significant post-year-end event was the March 10, 2025, drawdown of a **$25 million** second tranche from the OrbiMed credit facility, following the satisfaction of revenue and cash conditions - On March 10, 2025, the company's U.S. subsidiary drew down an additional **$25 million** in gross proceeds from its credit agreement with OrbiMed, representing the second tranche of the facility[55](index=55&type=chunk) [Research and development](index=11&type=section&id=1.3.%20Research%20and%20development) In 2024, MDxHealth's R&D focused on developing its clinical diagnostic product pipeline, with extensive work dedicated to solutions for prostate and bladder cancers - The company's 2024 R&D activities centered on product development projects for its clinical diagnostic pipeline[57](index=57&type=chunk) - Extensive development work was performed on clinical solutions specifically for prostate and bladder cancers[57](index=57&type=chunk) [Use of financial instruments](index=11&type=section&id=1.4.%20Use%20of%20financial%20instruments) The company's primary financial risks include Euro currency exposure, interest rate risk from its variable-rate OrbiMed credit facility, and credit risk on its **$46.8 million** cash deposits, for which it does not currently use hedging instruments - The company's currency risk is concentrated on its European operations and the Euro, for which it does not currently use hedging instruments[58](index=58&type=chunk) - The company is exposed to interest rate risk through its OrbiMed credit facility, which accrues interest at a variable rate equal to the greater of the SOFR rate or **2.50%**, plus **8.50%**[59](index=59&type=chunk) - Credit risk on cash and cash equivalents of **$46.8 million** is considered limited as the counterparties are banks with high credit scores[60](index=60&type=chunk) [Public takeover bids](index=12&type=section&id=1.5.%20Public%20takeover%20bids) No public takeover bids were made in 2024, and the company's de-listing from Euronext Brussels on December 18, 2023, changed its status under Belgian law regarding takeover regulations - The board of directors confirmed that no takeover bid was instigated by third parties in respect of the Company's equity during the financial year 2024[63](index=63&type=chunk) - As a result of the de-listing from Euronext Brussels on December 18, 2023, the Company no longer qualifies as a listed company or public-interest entity under the Belgian Companies and Associations Code[62](index=62&type=chunk) [Branch offices](index=12&type=section&id=1.6.%20Branch%20offices) While MDxHealth SA has no branches, the group operates a second U.S. laboratory in Plano, Texas, known as MDxHealth Central - The Company does not have any branches[64](index=64&type=chunk) - MDxHealth operates a second U.S. laboratory, Delta Laboratories LLC (d/b/a MDxHealth Central), located in Plano, Texas[64](index=64&type=chunk) [Justification of valuation rules on the basis of going concern](index=12&type=section&id=1.7.%20Justification%20of%20valuation%20rules%20on%20the%20basis%20of%20going%20concern) Despite a history of net losses and an accumulated deficit of **$369.5 million**, management justifies the going concern basis on **$46.8 million** in cash and expected access to additional funding for at least the next twelve months - The company has a history of net losses and an accumulated deficit of **$369.5 million** as of December 31, 2024, which could raise doubt about its ability to continue as a going concern[65](index=65&type=chunk) - Management justifies the going concern assumption based on its cash and cash equivalents of **$46.8 million** and its expected ability to access additional cash through debt, equity, or other means to fund operations for at least the next twelve months[66](index=66&type=chunk) [Conflicts of interests and related party transactions](index=12&type=section&id=1.8.%20Conflicts%20of%20interests%20and%20related%20party%20transactions%20%28Articles%207%3A96%20and%207%3A97%20BCAC%29) Two conflicts of interest involving CEO Mr. McGarrity regarding executive remuneration were reported in 2024, with Mr. McGarrity recusing himself and the board approving committee recommendations - Conflicts of interest were reported for CEO Mr. McGarrity at board meetings on February 20, 2024, and October 24, 2024[70](index=70&type=chunk)[71](index=71&type=chunk)[73](index=73&type=chunk) - The conflicts pertained to discussions and resolutions regarding executive remuneration and compensation matters In both cases, Mr. McGarrity did not take part in the deliberation or voting on these items[71](index=71&type=chunk)[73](index=73&type=chunk) - The board approved the recommendations of the Nomination and Remuneration Committee regarding executive compensation, severance, and success bonus programs to better align with US market practice for a Nasdaq-only listed company[72](index=72&type=chunk)[75](index=75&type=chunk)[77](index=77&type=chunk) [Acquisition of own shares](index=15&type=section&id=1.9.%20Acquisition%20of%20own%20shares%20%28Article%207%3A220%20BCAC%29) The company confirms that neither it nor any person acting on its behalf acquired any of the company's own shares during the 2024 financial year - Neither the Company nor any person acting on its behalf acquired shares of the Company during the financial year 2024[79](index=79&type=chunk) [Transactions under the authorised capital](index=15&type=section&id=1.10.%20Transactions%20under%20the%20authorised%20capital%20%28Article%207%3A203%20BCAC%29) In 2024, the company established a **$50 million** ATM facility and completed a public offering, issuing **22,209,241** shares for approximately **$44.1 million** in gross proceeds - On April 30, 2024, the company established an "at the market offering" (ATM) facility with TD Cowen to sell up to **$50 million** in new shares[80](index=80&type=chunk) - In September and October 2024, the company completed a registered public offering, issuing a total of **22,209,241** new ordinary shares[82](index=82&type=chunk)[84](index=84&type=chunk)[85](index=85&type=chunk) 2024 Registered Public Offering Details | Date | Shares Issued | Gross Proceeds (USD) | | :--- | :--- | :--- | | September 2024 | 20,000,000 | $40.0 million | | October 2024 (Overallotment) | 2,209,241 | ~$4.1 million (based on share count and initial price) | | **Total** | **22,209,241** | **~$44.1 million** |

Company Announcement - MDxHealth SA will release its financial results for the first quarter ended March 31, 2025, after market close on May 14, 2025 [1] - A conference call will be held on the same day at 4:30pm ET / 22:30 CET, featuring CEO Michael K. McGarrity and CFO Ron Kalfus [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 (methylation), and other molecular technologies to assist in the diagnosis and prognosis of urologic cancers and diseases [3] - MDxHealth's U.S. headquarters and laboratory operations are located in Irvine, California, with additional operations in Plano, Texas, and European headquarters in Herstal, Belgium [3]

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)** |