Financial Data and Key Metrics Changes - Full-year revenue for 2025 was $8.3 million, a 5% decrease compared to 2024, primarily due to lower consumables utilization and reduced international contributions [11] - Fourth-quarter revenue was $2.4 million, representing a 4% increase year-over-year and a 9% sequential increase, driven by a 208% increase in U.S. console sales [9][10] - Gross margin for the fourth quarter improved to 68.2%, up from 58.4% in the prior year [7][10] - Full-year operating expenses were $16.2 million, slightly lower than the previous year, reflecting improved expense discipline [11] Business Line Data and Key Metrics Changes - U.S. console sales increased by 208%, with 8 units sold compared to 3 in the prior year [9] - International sales increased by 59% year-over-year, largely due to last-time buys from distributors [9] - Heart failure and pediatrics segments grew by 8% and 14% year-over-year, respectively, while critical care revenue declined by 19% [11] Market Data and Key Metrics Changes - The company reduced exposure in certain international markets, particularly in the European Union, where it had consistently lost money [16] - The strategic rationalization of international contributions was a key factor in the overall revenue decline [11] Company Strategy and Development Direction - The company focused on the cardiorenal continuum, emphasizing the interrelation between cardiac and renal conditions [6] - A significant operational change included transitioning manufacturing to KDI Precision Manufacturing to enhance reliability and scalability [5] - The company aims to concentrate resources in areas with strong clinical adoption and economic value, rather than broad-based expansion [8] Management's Comments on Operating Environment and Future Outlook - Management highlighted 2025 as a year of structural change and repositioning, with a focus on operational strengthening and strategic clarity [4][25] - The company plans to maintain financial rigor, strengthen margin consistency, and prioritize capital efficiency as it scales into 2026 [26] - The integration of the Rendiatech acquisition is expected to enhance product offerings and improve utilization within existing accounts [22][26] Other Important Information - The company ended 2025 with approximately $1.2 million in cash and no outstanding debt, having raised about $7 million in net proceeds through financing activities [11] - The appointment of Carisa Schultz as Chief Financial Officer is expected to enhance financial leadership and operational transparency [8] Q&A Session Summary Question: Discussion on operational changes and sales focus - Management reinforced the direct sales team and focused on increasing utilization within existing accounts, particularly in critical care [15][21] Question: Incorporation of Rendiatech products into the portfolio - Rendiatech's technology will enhance the measurement of renal output in critical care, providing real-time data that is crucial for kidney health [18][19]

Financial Data and Key Metrics Changes - Full-year revenue for 2025 was $8.3 million, a 5% decrease compared to 2024, primarily due to lower consumables utilization and reduced international contributions [12] - Fourth quarter revenue was $2.4 million, representing a 4% increase year-over-year and a 9% sequential increase, driven by a 208% increase in U.S. console sales [10][11] - Gross margin for the fourth quarter improved to 68.2%, up 9.9 percentage points from the prior year [11] - Full-year operating expenses were $16.2 million, slightly lower than the prior year, reflecting improved expense discipline [12] Business Line Data and Key Metrics Changes - U.S. console sales increased by 208%, with 8 units sold compared to 3 in the prior year [10] - Heart failure and pediatrics segments grew by 8% and 14% year-over-year, respectively, while critical care revenue declined by 19% [12] - International sales increased by 59% year-over-year, largely due to last-time buys from distributors [10] Market Data and Key Metrics Changes - The company reduced exposure in certain international markets, particularly in the European Union, where it had been losing money [18] - The focus has shifted towards geographies with more predictable clinical demand and commercial conversion [5] Company Strategy and Development Direction - The company has clarified its strategic focus around the cardiorenal continuum, emphasizing the interrelation between cardiac and renal conditions [6] - A significant operational change included transitioning manufacturing to KDI Precision Manufacturing to enhance reliability and scalability [5] - The company aims to concentrate resources in areas with strong clinical adoption and economic value, rather than broad-based expansion [9] Management's Comments on Operating Environment and Future Outlook - Management described 2025 as a year of structural change and repositioning, with a focus on operational strengthening and strategic clarity [4][28] - The company plans to maintain financial rigor, strengthen margin consistency, and prioritize capital efficiency as it scales [29] - The integration of the Rendiatech acquisition is expected to enhance utilization within existing accounts, particularly in critical care [25] Other Important Information - The company ended the year with approximately $1.2 million in cash and no outstanding debt, emphasizing liquidity management as a priority [5][12] - The company received a National Institutes of Health grant to support pediatric device development, reinforcing the importance of this area [7][19] Q&A Session Summary Question: Discussion on operational changes and sales focus - Management reinforced the direct sales team and focused on increasing utilization within existing accounts, particularly in critical care [17][24] Question: Inquiry about the Rendiatech acquisition - The acquisition is expected to enhance capabilities in critical care, particularly in measuring renal output and electrolytes at the bedside [20][21]

Financial Data and Key Metrics Changes - Revenue for the second quarter was CAD1.7 million, a year-over-year decline of 21% [5][13] - Gross margin for the quarter was 55.5%, down from 67.2% in Q2 2024 [14] - Operating loss for Q2 was $2.9 million compared to $2.3 million in Q2 2024 [15] - Net loss attributable to common shareholders was $12.6 million, or a loss of $60.99 per share, compared to a net loss of $7.7 million, or a loss of $791.22 per share for the same period in 2024 [15] Business Line Data and Key Metrics Changes - Pediatric revenues increased by 23% compared to 2024 [13] - Heart failure and critical care revenues declined by 53% and 35% respectively, significantly impacted by the temporary backorder [13] Market Data and Key Metrics Changes - The pediatrics business remains strong with ongoing interest from new centers [7] - The outpatient heart failure opportunity is expected to grow due to increased reimbursement rates [23] Company Strategy and Development Direction - The company is focused on strengthening fundamentals, operational discipline, and strategic investments in high-impact growth areas [5] - Key growth areas identified include cardiac surgery, pediatrics, and outpatient heart failure [11][17] - The transition to KDI precision manufacturing is planned for October, expected to yield operational efficiencies and cost savings [9] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in navigating temporary setbacks and emphasized a commitment to delivering value to patients and shareholders [16] - The company aims to progress towards being cash flow positive and deepen outpatient engagement with heart failure programs [17] Other Important Information - The company ended the REVERSE HF clinical trial to reallocate approximately $4 million towards higher impact growth areas [10] - The company ended the quarter with $4.5 million in cash and cash equivalents and remains debt-free [15] Q&A Session Summary Question: Resolution of sterilization vendor issue and impact on Q3 - The issue was resolved in July, and the company is no longer in backorder, rapidly building finished goods inventory [20][21] Question: Largest opportunity among pediatrics, critical care, and heart failure - Management sees growth opportunities in all three areas, with heart failure expected to grow the fastest due to outpatient opportunities and increased reimbursement [22][23]

Financial 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 reimbursement 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 [17] - 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 [19] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the stability of critical care business volume, expecting it to return to normal levels in the upcoming quarter [23] - The company is actively working with hospitals to implement outpatient clinics, anticipating revenue growth in the second quarter and more rapid growth in the third and fourth quarters [26] 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 is focused on disciplined expense management, achieving a 31% reduction in operating expenses [20] Q&A Session Summary Question: What caused the drop in adult revenue? - The drop in critical care was primarily due to a large customer building inventory in the previous quarter, leading to lower purchases in Q1 [23] Question: Is the drop in Q1 revenue seasonal? - Management indicated that the drop was not typical seasonality but rather specific to a recall incident affecting inventory management [24] Question: What does expanding the outpatient pipeline mean for Aquadex? - The company is working with four hospitals to implement outpatient clinics, focusing on logistical changes and nursing resources [25] Question: Update on Phase three trial enrollment and VIVIAN clinical trial timeline? - Enrollment for the REVERSE HF trial is ongoing, with efforts to increase enrollment resuming after previous issues [28] - The VIVIAN clinical trial will not start until later this year or early next year, pending further device development [29]

Financial 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]