MDxHealth SA(US:MDXH)2022-03-03 00:49Financial Data and Key Metrics Changes - Q4 2021 revenue grew by 46% compared to Q4 2020, while full-year 2021 revenue increased by 20% over the previous year, reaching $22.2 million [4][11] - Services revenue amounted to $21.9 million, a 21% increase from $18.1 million in 2020, with ConfirmMDx representing over 90% of service revenue [11][12] - Gross margins improved to 47.5% in 2021 from 43.6% in 2020, reflecting a growth margin improvement of 390 basis points [12] Business Line Data and Key Metrics Changes - The company experienced modest test volume increases in 2021 despite pandemic challenges, with accelerated revenue growth attributed to improved revenue cycle management and higher average selling prices [7][11] - The introduction of a urinary tract infection (UTI) testing service in Q4 2021 is expected to contribute to revenue in 2022, with early adoption indicators being positive [9][10] Market Data and Key Metrics Changes - Prostate cancer screening rates were estimated to be down 50% due to the pandemic, impacting patient flow and sales rep access [4][5] - The company anticipates a return to pre-pandemic volumes for both Confirm and Select tests as restrictions ease and patient flow returns [5][6] Company Strategy and Development Direction - The company aims to expand its menu into active surveillance, providing additional growth opportunities, with updates expected mid-year [16][17] - The management emphasizes a commitment to execution and sustainable growth, aiming to drive adoption of clinical pathways and enhance payer coverage [15][18] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence that headwinds from the pandemic will turn into growth-driving tailwinds in 2022, with expectations for revenue between $25 million and $27 million [3][16] - The management highlighted the importance of the final Medicare coverage decision for SelectMDx tests, which is expected to contribute to revenue in the second half of 2022 [16][27] Other Important Information - The company ended 2021 with $58.5 million in cash, bolstered by equity raises and an initial public offering [14] - Operating expenses for 2021 were $37.4 million, up 6% from 2020, primarily driven by R&D expenses related to future product pipelines [12][13] Q&A Session Summary Question: Impact of Omicron on Test Volumes - Management acknowledged challenges from Omicron but noted a return in patient flow and sales rep access, expecting improvements as they move into Q2 [20][21] Question: Timing for Active Surveillance Program Launch - Management indicated that visibility on key drivers will improve by mid-year, but no revenue contribution from active surveillance is expected in 2022 [22][23] Question: UTI Testing Reimbursement and ASP - Management confirmed positive early experiences with UTI testing and is gathering data on reimbursement rates to provide future guidance [31][34] Question: Sales Force Expansion Opportunities - Management stated that current revenue guidance does not imply additional sales force expansion, but they are prepared to accelerate growth if patient flow returns [35][37] Question: SelectMDx and ConfirmMDx Adoption - Management expressed confidence in the growth potential of both tests, with SelectMDx expected to drive unit growth due to its larger market size [41][42] Question: UTI Testing Volume and Reimbursement - Management confirmed that UTI testing has been fully launched and is expected to contribute to revenue, with ongoing analysis of reimbursement landscapes [49][50] Question: Select Test and LCD Coverage - Management views the anticipated LCD coverage as a catalyst for broader commercial payer coverage, similar to past experiences with ConfirmMDx [53][54]