Nuwellis(NUWE)2025-05-13 14:00Financial Data and Key Metrics Changes - Newellis generated $1.9 million in revenue for Q1 2025, representing a 3% increase year over year, supported by a 4% increase in consumables utilization and an increase in U.S. console sales, partially offset by a decrease in international sales [6][13] - Gross margin for Q1 was 56%, down from 64.1% in the same period last year, primarily due to unfavorable manufacturing variances and lower fixed overhead absorption [14] - Operating loss narrowed to $3.1 million compared to an operating loss of $4.7 million in the prior year quarter [15] Business Line Data and Key Metrics Changes - Pediatric and heart failure revenues increased by 3828% year over year, driven by growth in consumables utilization [6][13] - Critical care revenue declined by 25% year over year, primarily due to one of the largest customers building excess inventory in the previous quarter [7][13] Market Data and Key Metrics Changes - The company has built a growing pipeline of target outpatient facilities, representing an addressable market opportunity of approximately $717 million [12] - The recent reassignment of OXWAD X to a new outpatient reimbursed level by CMS increased the facility reimbursement fee for the therapy by nearly four times to $16.39 per day [11] Company Strategy and Development Direction - Newellis is focusing on critical care, pediatrics, and outpatient heart failure, with critical care representing approximately 40% of current business [18] - The company aims to position Aquadex as a standard of care within fluid management, expanding into the outpatient market as hospital accounts complete logistical challenges [20] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the stabilization of critical care business volume in the upcoming quarter after a temporary decline [7][24] - The company is actively working with hospitals to implement outpatient clinics, expecting to see revenue growth in the second quarter and more rapid growth in the third and fourth quarters [28] Other Important Information - Newellis ended the quarter with $2.6 million in cash and cash equivalents and operates with no debt on the balance sheet [16] - The company has signed an agreement with KDI Precision Manufacturing to move manufacturing, which is expected to result in meaningful expense reductions over the next twelve months [22] Q&A Session Summary Question: Was the drop in adult revenue entirely due to lower international sales? - The drop in critical care was primarily due to a large customer building inventory in the previous quarter, and they have begun repurchasing in the second quarter [24] Question: Is the drop in the first quarter seasonal? - Management indicated that there is not a lot of seasonality in the business, attributing the drop to a specific incident rather than a recurring pattern [25][26] Question: What does expanding the outpatient pipeline mean for Aquadex? - The company is currently working with four hospitals to implement outpatient clinics, identifying locations and nursing resources necessary to support these clinics [27] Question: Can you provide an update on the Phase three trial enrollment with Aquadex? - Enrollment for the REVERSE HF trial is ongoing, and the company is about halfway to its goal of 372 patients [30] Question: What is the timeline for the VIVIAN clinical trial? - The clinical trial will not start until later this year or early next year, pending further development of the device [31]