Nuwellis(US:NUWE)2025-03-11 16:23Financial Data and Key Metrics Changes - Nuwellis generated $2.3 million in revenue for Q4 2024, a 9% decrease year-over-year due to a decline in U.S. console sales and international sales, offset by a 21% increase in consumables utilization [10][20] - Gross margin improved to 58.4% for Q4 2024 compared to 54.4% in the prior year quarter, driven by higher manufacturing volumes of consumables and lower fixed overhead manufacturing expenses [21] - Net loss attributable to common shareholders in Q4 was $1.5 million, or a loss of $0.44 per share, compared to a net loss of $7.9 million, or a loss of $54.48 per share for the same period in 2023 [24][25] Business Line Data and Key Metrics Changes - The Critical Care business, the largest customer category, saw a 35% year-over-year quarterly revenue growth, benefiting from higher console sales and consumable utilization [11][20] - Heart failure and pediatric customer categories experienced declines of 36% and 20% respectively due to lower console sales [12][20] Market Data and Key Metrics Changes - The company reported nine new account wins throughout 2024, indicating positive market penetration [9] - A favorable reimbursement change effective January 1, 2025, allows Nuwellis to enter the outpatient services market for Aquadex technology, with the facility reimbursement fee increasing nearly fourfold from $413 to $1,639 per day [14][15] Company Strategy and Development Direction - Nuwellis aims to build its body of clinical evidence to make Aquadex Ultrafiltration therapy a standard of care and integrate it into medical society guidelines [12] - The company is focused on driving market penetration of Aquadex Ultrafiltration therapy, leveraging clinical evidence and increased reimbursement rates in the outpatient setting [16] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism for 2025, highlighting the positive impact of new account wins and reimbursement changes on growth [9] - The recent publication in JACC: Heart Failure demonstrated a 60% reduction in heart failure events for patients treated with Aquadex compared to traditional IV diuretics, which is expected to support broader adoption of the technology [13][18] Other Important Information - The company had a voluntary recall of specific lots of blood circuit units, which resulted in a non-recurring expense of approximately $150,000 [22] - Total operating expenses decreased by approximately 25% compared to Q4 2023, reflecting savings from operational efficiency initiatives [24] Q&A Session Summary Question: Initial traction in the outpatient setting for Aquadex - Management noted that traction is beginning with several existing accounts needing to set up permanent outpatient facilities, with more activity expected in the coming month [29] Question: Number of Aquadex units sold in Q4 2024 and Q3 2024 - Three units were sold in Q4 2024, compared to 11 units in Q3 2024 [33][35] Question: Timing for reverse HF trial enrollment completion - Management indicated it is difficult to gauge the timing for enrollment completion [37] Question: Timing for the start of the Vivian clinical trial - Management provided a similar response, stating it is difficult to predict [39] Question: Changes in leadership and search for a new CEO - Management confirmed that a search firm has been hired and candidates are being evaluated, with no immediate need for major changes in direction [46]