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 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]

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]