MDxHealth SA

Good day, ladies and gentlemen, and welcome to the MDX Health Full Year Results and Business Update Conference Call. As a reminder, this conference is being recorded. At this time, I would like to turn the conference over to Troy Williams of LifeSci Advisors. Please go ahead. Today, we are experiencing a momentary delay. Please stand by.

These forward-looking statements are subject to inherent risks and uncertainties. These risks and uncertainties are detailed in the company's most recent annual report. MDX Health expressly disclaims any obligation to update any such forward-looking statements to reflect any changes in its expectations with regard thereto or any change in events, conditions, or circumstances on which any such statement is based unless required by law or regulation. I will now turn the call over to Mike McGarrity, CEO of MDX Health.

Thanks, David. And thank you all for joining us for our 2021 full year release of results for MDX Health. With me today is Ron Kelfis, Chief Financial Officer. We believe we are at a clear turning point in the growth of MDX Health and that this growth will be sustainable. While we have continued to face headwinds of patient flow and sales rep access associated with the pandemic, we are confident that in 2022, These will all begin to turn to growth-driving tailwinds. I will speak to the specifics of and the basis to our view, and Ron will comment on our financial and operating results for the quarter and year. But first, let me point to a few highlights. Our Q4 revenue grew by 46% over Q4 2020, and our full-year 2021 revenue grew 20% over prior year. demonstrating our efforts to continue to drive adoption of our clinical pathway menu for prostate cancer, even amidst the lingering impact of Delta and Omicron variants associated with the pandemic. These growth rates are particularly encouraging in light of the clear impact of the pandemic on cancer screenings, with prostate cancer screening rates estimated to be down 50%, coupled with sales rep access limited by a similar factor. Absent any surge in the pandemic variance, we are trending toward our pre-pandemic volumes for both confirm and select. We expect this trend to continue and drive sustainable growth going forward. We also are confident that our sales team is engaged in driving both our total ordering physician base and our committed clinical pathway adoption within that base. Internally, we view these metrics as the critical drivers of adoption, unit growth, and revenue. As restrictions ease, patient flow returns, and rep access reopens, we will begin to report on these metrics. Our patient flow has been particularly impacted as our current menu is pre-cancer diagnosis. This is an important delineation as it lends itself to a greater restriction of patient flow compared to patients already diagnosed with cancer. And while prostate cancer rates have elevated during this period due to delayed screenings noted, and positive biopsy rates will likely trend higher for a period, we believe this reflects our underlying growth as we return to normal dynamics in the market. our total ordering urologist has not been adversely affected through the pandemic. And we view this as a leading indicator of our return to growth. It should also be noted that while our test volume increased modestly in 2021, in spite of these factors, our accelerated revenue growth reflects our demonstrated commitment to operating discipline and advancement of our payer coverage and associated reimbursement for our confirmed tests. We are confident that the same growth leverage will apply to our comparable select MDX test volume beginning in 2022, with the finalization of the MoldDx foundational LCD covering our select MDX indication. Moving to our market introduction of a urinary tract or UTI testing service in the last quarter of 2021, we are encouraged by our progress based on a number of leading indicators. First and foremost, our diligence around the market, competitive landscape, and alignment of the UTI test with our focus into urology and fit and adoption within our current menu customer base has been confirmed. Second, we are beginning to see adoption of our UTI offering even amidst the market and access challenges noted. Finally, We expect UTI testing services to begin contributing to revenue in 2022, and we'll provide additional comment on our view forward and guidance for 2022. But first, let me turn the call over to Ron for a review of our financial and operating results for 2021. I'm sorry, for 2020. Ron?