Financial Data and Key Metrics Changes - Nuellis generated $2,300,000 in revenue for Q4 2024, a 9% decrease year over year due to a decline in U.S. console sales and international sales, partially offset by a 21% increase in consumables utilization [8][15] - 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 [16] - Net loss attributable to common shareholders in Q4 was $1,500,000 or a loss of $0.44 per share, an improvement from a net loss of $7,900,000 or a loss of $54.48 per share for the same period in 2023 [18] Business Line Data and Key Metrics Changes - Critical care customer category posted a 35% year-over-year revenue growth, benefiting from higher console sales and consumable utilization [9][15] - Heart failure and pediatric customer categories experienced declines of 36% and 20% respectively due to lower console sales [9][15] Market Data and Key Metrics Changes - The company reported nine new account wins throughout 2024, indicating positive market penetration [7] - The reimbursement for Aquadex Ultrafiltration therapy increased nearly fourfold from $413 to $16,390 per day effective January 1, 2025, allowing entry into the outpatient market [11] Company Strategy and Development Direction - The company aims to build its clinical evidence to make Aquadex Ultrafiltration Therapy a standard of care and integrate it into medical society guidelines [10] - The focus remains on driving market penetration of Aquadex Ultrafiltration Therapy, leveraging the increased reimbursement in the outpatient setting [12] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism for 2025, highlighting the positive impact of new reimbursement changes and clinical data supporting Aquadex therapy [7][10] - The management acknowledged the importance of the recent publication in JACC Heart Failure, which demonstrated a 60% reduction in heart failure events for patients treated with Aquadex compared to traditional IV diuretics [10][12] Other Important Information - The company had $5,100,000 in cash and cash equivalents with no debt on the balance sheet as of December 31, 2024 [18] - A voluntary recall of specific lots of blood circuit units occurred in December 2024, which included a non-recurring expense of approximately $150,000 [16] 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 [21] Question: Number of Aquadex units sold in Q4 2024 - Three units were sold in Q4 2024, compared to eleven units in Q3 2024 [23] Question: Timing for REVERSE HF trial completion - Management indicated that it is difficult to gauge the timing for enrollment completion and initial top-line data [24] Question: Timing for the start of the VIVIAN clinical trial - Similar to the REVERSE HF trial, management stated that predicting the start timing is also difficult [25] Question: Changes in leadership and search for a new CEO - Management confirmed that a search firm has been hired for the CEO search, and there are several candidates being considered [33]

Financial Data and Key Metrics Changes - Nuellis generated $2,300,000 in revenue for Q4 2024, a 9% decrease year over year due to a decline in U.S. console sales and international sales, partially offset by a 21% increase in consumables utilization [8][15] - Gross margin improved to 58.4% for Q4 2024 compared to 54.4% in the prior year, driven by higher manufacturing volumes of consumables and lower fixed overhead manufacturing expenses [16] - Net loss attributable to common shareholders in Q4 was $1,500,000 or a loss of $0.44 per share, an improvement from a net loss of $7,900,000 or a loss of $54.48 per share in the same period in 2023 [18] Business Line Data and Key Metrics Changes - The critical care customer category posted a 35% year-over-year revenue growth, benefiting from higher console sales and consumable utilization [9][15] - Heart failure and pediatric customer categories experienced declines of 36% and 20% respectively due to lower console sales [9][15] Market Data and Key Metrics Changes - The company reported nine new account wins throughout 2024, indicating positive market penetration [7] - A new reimbursement change effective January 1, 2025, increased the facility reimbursement fee for Aquadex Ultrafiltration therapy nearly fourfold, from $413 to $1,639 per day, allowing entry into the outpatient market [11] Company Strategy and Development Direction - The company aims to build its clinical evidence to make Aquadex Ultrafiltration Therapy a standard of care and integrate it into medical society guidelines [10] - The focus remains on driving market penetration of Aquadex Ultrafiltration Therapy, leveraging clinical evidence and increased reimbursement in the outpatient setting [12] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism for 2025, highlighting the positive impact of new reimbursement changes and clinical data supporting Aquadex therapy [7][10] - The management acknowledged the importance of the recent publication in JACC Heart Failure, which demonstrated significant clinical benefits of Aquadex over traditional IV diuretics [10][31] Other Important Information - The company had $5,100,000 in cash and cash equivalents with no debt on the balance sheet as of December 31, 2024 [18] - A voluntary recall of specific lots of blood circuit units incurred a non-recurring expense of approximately $150,000 [16] 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 [21] Question: Number of Aquadex units sold in Q4 2024 - Three units were sold in Q4 2024, compared to eleven units in Q3 2024 [23] Question: Timing for completion of the REVERSE HF trial enrollment - Management indicated that it is difficult to gauge the timing for completion of enrollment but is pleased with investigator engagement [24] Question: Search for a new CEO - The search for a new CEO is actively underway, with a search firm hired and potential candidates being considered [33]