MDxHealth SA

To ask a question, you may press star, then one on your telephone keypad. To withdraw your question, please press star, then two. Please note, this event has been recorded. I would now like to turn the conference over to Mr. John Fernandez with LifeSite Advisors. Please go ahead.

Good afternoon, and thank you for joining us for the MDX Health First Quarter 2025 Earnings Conference Call. Joining me on today's call are Michael McGarrity, Chief Executive Officer, and Ron Kalpas, Chief Financial Officer. Before we begin, I would like to remind everyone that the company will be making forward-looking statements during today's call. Whether in prepared remarks or during the Q&A session, these forward-looking statements are subject to inherent risks and uncertainties. These risks and uncertainties are detailed in the risk factor section of the company's filings with the Securities and Exchange Commission, specifically in the company's annual report on Form 20F. I'll now turn the call over to Michael McGarrity, Chief Executive Officer. Thanks, John.

And thank you all for joining us for the first quarter 2025 Earnings Conference Call for MDX Health. With me today is Ron Kalfas, Chief Financial Officer. Our Q1 results reflect continued execution across our organization, led by our commercial team. And we remain well on track to achieve our goal of 20% or greater revenue growth in 2025 and beyond. As further evidence of our commitment to this growth objective, I think it's important to note that this Q1 2025 is our 16th consecutive quarter of 20% or greater revenue growth for MDX Health. Again, we expect our results every quarter to reflect our unwavering focus on operating discipline and commercial execution. As we look at our progress, I would point to a number of defining milestones that reflect the talent, commitment, and success of the team across our organization. We achieved Q1 revenue growth of 22% and our tissue-based test volume grew 41% for the quarter. More specifically, Q1 total billable volume was approximately 24,000 tests, representing total test unit growth of 24%. Volumes for our tissue-based tests, which include confirmed MDX and GPS, came in at approximately 12,600 for the quarter, an increase of 41% over the prior year period. For our liquid-based tests, which include SelectMDX, ResolveMDX, and Germline, test volumes were almost 12,000, an increase of 9% over the prior year period. It is clear that a number of key factors are driving the continued growth of the tissue-based segment of our menu, which accounted for 85% of our Q1 revenue. The diagnostic value of our confirmed tests is becoming increasingly appreciated by our urology customers. And our accelerated growth is evidence of the influence our focus on pathology has provided as a key supporting driver of urology adoption. The confirmed test has several unique value attributes that account for this growth trajectory. Most notably, it is estimated that 30% of negative initial biopsies are false negatives. This is not a function of a poor biopsy by the urologist, nor a missed read by pathology. It is solely due to the limitations of needle biopsy that sample less than 1% of the prostate. Our confirmed test addresses this limitation by interrogating each core of the biopsy. And with a 96% negative predictive value, confirmed can obviate or defer the need for repeat biopsy. which is often a reflex protocol for these patients. Of equal importance and value, a positive confirmed test identifies the specific core or core of the biopsy that may indicate a lesion, informing follow-up or intervention for the patient. The value to the patient of avoiding potentially unnecessary repeat biopsies coupled with the corresponding value of detecting cancer that was missed upon initial biopsy, carries compelling value from both a healthcare economics and patient care perspective. Based on this compelling clinical value, we believe the market opportunity for CONFIRM is quite significant and growing with the rate of prostate cancer rising an estimated 5% to 10% annually. we have demonstrated that CONFIRM is relevant for every negative biopsy. And with no competitive tissue test to meet this unique and clinically actionable value, we are confident in CONFIRM's continued accelerating growth and our ability to capture a significant portion of this $500 million market opportunity. Our genomic prostate score, or GPS test, presents a similarly compelling value to both clinician and patient. Our GPS test measures the expression levels of a group of cancer-related genes that are in a patient's tumor tissue. The activity of these genes can provide important information about how a specific cancer might best be treated. In 2022, we acquired the GPS test from Exact Sciences, informed by our diligence, and based on the thesis that the strength of our channel and access to large urology group practices, coupled with our advanced access to pathology, would not only accelerate GPS revenue but also drive gross margin accretion for our overall business. It was also critical to establishing our partnership with urologists by informing care following biopsy. We now stand alone as the only company that can deliver actionable diagnostic answers to both positive and negative patient profiles. And while there are two competitors in the GPS market opportunity, we are confident that our thesis is becoming reality. As our growth rate indicates, we are both converting the market and taking competitive share based on focus, execution, and a few key characteristics and dynamics in the clinical practice of prostate cancer. The quality of data associated with GPS for localized prostate cancer patients, which is estimated to account for approximately 70% of the eligible patient population, is, we believe, the most compelling, with 20-year follow-up data for both adverse pathology and and prostate-specific mortality. Also of note is the additional benefit that significantly less tumor tissue is needed for GPS than for competing tests, offering a higher valid result rate, serving a larger pool of eligible patients. This particular feature is, again, compelling to urologists and pathologists as it provides a pathway that is best for patients. Each of these features of our tissue-based tests positions MDX Health as a clear leader in precision diagnostics for prostate cancer, providing the highest quality diagnostic menu for clinicians and patients. Based on the proprietary value of this menu, coupled with the talent and execution of our sales and support teams, we remain confident in achieving our committed goal of 20% revenue growth, as we have now demonstrated consistently over the last 16 quarters. Of course, all of this progress and success would not be realized without all of our operating groups' dedication to our vision of being the most consistent growth company in the urology diagnostic space. True excellence is measured by performance over time. And we believe our consistent and strong performance quarter after quarter reflects that commitment to excellence. To summarize, I believe no other company is better positioned to help improve the patient journey through prostate cancer diagnosis and treatment. And our results continue to reflect our success in bringing value to this patient population. Based on these dynamics, we are confirming our previously announced revenue guidance of $108 to $110 million for 2025, meeting or exceeding our 20% revenue growth goal, and delivering positive adjusted EBITDA in this Q2 of 2025. I will follow up with closing comments and view forward, but first let me turn the call over to Ron for review of our financial and operating results for Q1. Ron?