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MDxHealth SA(MDXH) - 2024 Q4 - Earnings Call Transcript

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]