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]

Offering Details - MDxHealth SA proposes to issue and sell an aggregate of 18,500,000 ordinary shares, with an additional option for up to 2,775,000 shares[2]. - The purchase price for the Firm Stock is set at $2.00 per Ordinary Share[76]. - The underwriting commission per ordinary share is set at $0.12[150]. - TD Securities (USA), LLC will purchase 8,880,000 firm shares and 1,332,000 optional shares, while William Blair & Company, L.L.C. will purchase 7,030,000 firm shares and 1,054,500 optional shares[146]. - The total number of shares to be purchased by all underwriters amounts to 18,500,000 firm shares and 2,775,000 optional shares[146]. Regulatory Compliance - The offering is made under a shelf registration statement filed with the U.S. Securities and Exchange Commission, which has been declared effective[1]. - The Registration Statement and Prospectus conform to the requirements of the Securities Act and do not contain any misleading statements[9]. - The Company has complied with all material terms of agreements related to licensed Intellectual Property, and all such agreements are currently in effect[29]. - The Company possesses valid and current regulatory permits required by authorities such as the FDA and Health Canada, with no notices of non-compliance received[31]. - The Company is in material compliance with all health care laws, including the Anti-Kickback Statute and HIPAA, with no adverse actions reported by governmental authorities[35]. - The Company is in compliance with all applicable provisions of the Sarbanes-Oxley Act and related regulations[51]. - The Company is in material compliance with all applicable data privacy and security laws, including GDPR[69]. Financial Condition - The financial statements of the Company fairly present its financial condition and results of operations in accordance with IFRS[26]. - The Company has not incurred any material liabilities or obligations or made any significant changes in its share capital since the last reporting date[18]. - The Company has received comfort letters from BDO Réviseurs d'Entreprises SRL, ensuring compliance with financial data in the General Disclosure Package[117]. - No downgrades in the Company's corporate credit rating or debt securities ratings have occurred since the execution of the Agreement[123]. Legal Matters - The Company has no pending or threatened legal proceedings that would result in a Material Adverse Effect[20]. - There are no ongoing legal proceedings that could materially affect the Company or its subsidiaries[32]. - The Company has not faced any legal impediments to the issuance or sale of the Securities[122]. - No labor disputes or problems are currently existing or threatened that could result in a Material Adverse Effect[62]. Internal Controls and Insurance - The Company maintains a system of internal controls over financial reporting that is effective and has not identified any significant deficiencies or material weaknesses[47]. - The Company and its subsidiaries carry adequate insurance coverage for their business and properties, with all policies in full force and effect[49]. Indemnification and Liability - The Company will indemnify the Underwriters against any Stamp Taxes imposed in connection with the issuance and delivery of the Securities[91]. - The Company has indemnified Underwriter Indemnified Parties against any losses arising from untrue statements or omissions in the offering documents[128]. - The indemnifying party must be notified in writing of any action against an indemnified party to assume the defense[130]. - The indemnifying party is liable for reasonable legal fees and expenses incurred by the indemnified party in connection with the defense[130]. Miscellaneous Provisions - The agreement is governed by the laws of the State of New York, with jurisdiction in the Federal and state courts in Manhattan[141]. - The Company acknowledges that no fiduciary relationship exists between it and the Underwriters[135]. - The agreement benefits only the parties mentioned and does not confer rights to any third parties[135]. - The Company agrees to prepare and file the Prospectus not later than the second business day following the execution of the Agreement[81].

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 ...

MDxHealth Reports Q2 and Half Year 2024 Results Year-over-year Q2 revenues increase by 32% to $22.2 million Year-over-year H1 revenues increase by 34% to 42.0 million Conference call with Q&A today at 4:30 PM ET / 22:30 CET IRVINE, CA, and HERSTAL, BELGIUM – August 21, 2024 (GlobeNewswire) – MDxHealth SA (NASDAQ: MDXH) (the "Company" or "mdxhealth"), a commercial-stage precision diagnostics company, today announced its financial results for the second quarter and half year ended June 30, 2024. Michael K. Mc ...

MDxHealth to Present Second Quarter and First Half 2024 Financial Results Title: MDxHealth Presents Second Quarter and First Half 2024 Financial Results and Corporate Update Conference Call and Webcast Speakers: Michael K. McGarrity, Chief Executive Officer Ron Kalfus, Chief Financial Officer Date: August 21, 2024 Time: 4:30pm ET/ 22:30 CET United States: 1-877-407-9716 Belgium: 0800 73 566 The Netherlands: 0800 022 3580 United Kingdom: 0 800 756 3429 Conference Call Dial-in Details: and Corporate Update on ...

Mdxhealth Appoints Sanford J. Siegel, M.D. to Board of Directors IRVINE, CA, and HERSTAL, BELGIUM – July 8, 2024 (GlobeNewswire) – MDxHealth SA (NASDAQ: MDXH) (the "Company" or "mdxhealth"), a commercial-stage precision diagnostics company, today announced the appointment of Sanford J. Siegel, M.D. to its Board of Directors. Dr. Siegel will be taking the seat of Lieve Verplancke M.D., who is stepping down from the Board of mdxhealth. Dr. Siegel has more the 45 years of experience as a practicing urologist a ...

The Company's cash balance as of June 30, 2024, was $21.3 million. About mdxhealth® The preliminary unaudited financial data for the second quarter and six-month period ended June 30, 2024, and the updated 2024 revenue guidance set forth above were derived from preliminary internal financial reports. The Company has not yet finalized its complete results of operations for the period ended June 30, 2024. The Company and its auditors may identify items that would require the Company to make adjustments, some ...