[PART I—FINANCIAL INFORMATION](index=3&type=section&id=PART%20I%E2%80%94FINANCIAL%20INFORMATION) This section details the company's financial performance, condition, and cash flows, alongside management's analysis, market risk disclosures, and internal control effectiveness [Item 1. Financial Statements](index=3&type=section&id=Item%201.%20Financial%20Statements) The unaudited condensed consolidated financial statements for Q1 2025 reveal a net loss of $3.0 million and an accumulated deficit of $301.8 million, raising substantial doubt about the company's going concern ability - The company's financial statements have been prepared on a going concern basis, but its history of losses, an accumulated deficit of **$301.8 million** as of March 31, 2025, and expected future losses raise substantial doubt about its ability to continue operations for at least twelve months from the filing date[23](index=23&type=chunk) - Existing capital resources are projected to be sufficient to support the operating plan only through **May 31, 2025**, requiring additional capital to continue operations and growth initiatives[26](index=26&type=chunk)[75](index=75&type=chunk) [Condensed Consolidated Balance Sheets](index=3&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) This table provides a snapshot of the company's financial position, detailing assets, liabilities, and equity as of March 31, 2025, and December 31, 2024 Condensed Consolidated Balance Sheet Highlights (in thousands) | Account | March 31, 2025 | December 31, 2024 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $2,557 | $5,095 | | Total current assets | $6,123 | $8,855 | | **Total Assets** | **$7,006** | **$9,864** | | **Liabilities & Equity** | | | | Total current liabilities | $2,749 | $2,559 | | Total liabilities | $3,424 | $3,334 | | Total stockholders' equity | $3,578 | $6,528 | | **Total Liabilities & Equity** | **$7,006** | **$9,864** | [Condensed Consolidated Statements of Operations](index=4&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) This table outlines the company's financial performance for the three months ended March 31, 2025 and 2024, including net sales, gross profit, operating expenses, and net loss Condensed Consolidated Statements of Operations (in thousands, except per share data) | Metric | Three months ended March 31, 2025 | Three months ended March 31, 2024 | | :--- | :--- | :--- | | Net sales | $1,904 | $1,857 | | Gross profit | $1,067 | $1,191 | | Total operating expenses | $4,127 | $5,940 | | Loss from operations | $(3,060) | $(4,749) | | Net loss | $(3,014) | $(4,330) | | Basic and diluted loss per share | $(0.69) | $(24.11) | [Condensed Consolidated Statements of Cash Flows](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) This table details the cash inflows and outflows from operating, investing, and financing activities for the three months ended March 31, 2025 and 2024 Condensed Consolidated Statements of Cash Flows (in thousands) | Activity | Three months ended March 31, 2025 | Three months ended March 31, 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | $(2,536) | $(2,862) | | Net cash used in investing activities | $0 | $(29) | | Net cash provided by financing activities | $0 | $500 | | Net decrease in cash and cash equivalents | $(2,538) | $(2,400) | | Cash and cash equivalents - end of period | $2,557 | $1,400 | [Notes to Condensed Consolidated Financial Statements](index=7&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) These notes provide essential context and additional details for the condensed consolidated financial statements, covering business operations, significant customer relationships, and recent strategic developments - The company's primary business is the commercialization of the Aquadex SmartFlow® system for ultrafiltration therapy in patients with fluid overload[19](index=19&type=chunk) - In Q1 2025, one customer accounted for **14% of net sales**; as of March 31, 2025, three customers represented **15%, 10%, and 10%** of the accounts receivable balance[28](index=28&type=chunk)[29](index=29&type=chunk) - On May 12, 2025, the company announced a strategic agreement with KDI Precision Manufacturing, which will assume assembly responsibilities for the Aquadex SmartFlow® Console and related products[55](index=55&type=chunk)[56](index=56&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=14&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses a 2.5% increase in Q1 2025 net sales, offset by a gross margin decline, alongside a 30.5% reduction in operating expenses and a critical liquidity situation requiring urgent additional financing [Results of Operations](index=17&type=section&id=Results%20of%20Operations) This section analyzes the company's net sales, cost of goods sold, and operating expenses, highlighting key changes and their drivers for the current and prior periods Comparison of Operating Results (in thousands) | Metric | Q1 2025 | Q1 2024 | Change ($) | Change (%) | | :--- | :--- | :--- | :--- | :--- | | Net Sales | $1,904 | $1,857 | $47 | 2.5% | | Cost of goods sold | $837 | $666 | $171 | 25.7% | | Selling, general and administrative | $3,577 | $4,606 | $(1,029) | (22.3)% | | Research and development | $550 | $1,334 | $(784) | (58.8)% | - The increase in net sales was driven by a **4% increase in circuit sales** and higher console sales, partially offset by lower international sales[78](index=78&type=chunk) - The decrease in SG&A and R&D expenses was primarily due to reduced headcount, lower compensation-related expenses, and decreased project spending[81](index=81&type=chunk)[82](index=82&type=chunk) [Liquidity and Capital Resources](index=18&type=section&id=Liquidity%20and%20Capital%20Resources) This section details the company's historical funding sources, current cash position, and projected capital needs, emphasizing the urgency for additional financing to sustain operations - The company has historically funded operations through equity issuances, including several offerings in 2024 that raised gross proceeds of approximately **$5.3 million**[83](index=83&type=chunk)[86](index=86&type=chunk)[90](index=90&type=chunk) - As of March 31, 2025, cash and cash equivalents were **$2.6 million**, a decrease from **$5.1 million** at the end of 2024[96](index=96&type=chunk) - Net cash used in operating activities decreased to **$2.5 million** in Q1 2025 from **$2.9 million** in Q1 2024, reflecting a lower net loss and changes in working capital[97](index=97&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=20&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company states this section is not applicable, indicating no significant exposure to market risks requiring detailed disclosure - The company has determined that quantitative and qualitative disclosures about market risk are not applicable[102](index=102&type=chunk) [Item 4. Controls and Procedures](index=21&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that disclosure controls and procedures were ineffective as of March 31, 2025, due to two material weaknesses in internal controls over financial reporting, with remediation planned - Management concluded that disclosure controls and procedures were not effective at a reasonable assurance level as of March 31, 2025[105](index=105&type=chunk) - The ineffectiveness was attributed to two material weaknesses in controls over financial reporting, as detailed in the 2024 Annual Report on Form 10-K[105](index=105&type=chunk) [PART II—OTHER INFORMATION](index=21&type=section&id=PART%20II%E2%80%94OTHER%20INFORMATION) This section covers legal proceedings, updated risk factors, equity sales, potential defaults, and other miscellaneous information and exhibits [Item 1. Legal Proceedings](index=21&type=section&id=Item%201.%20Legal%20Proceedings) The company reports no legal proceedings requiring disclosure for the period - The company reports no legal proceedings[108](index=108&type=chunk) [Item 1A. Risk Factors](index=21&type=section&id=Item%201A.%20Risk%20Factors) This section supplements previously disclosed risk factors, emphasizing risks from off-label product use, U.S. trade policies, FDA disruptions, and reliance on sole source suppliers - The company faces risks of substantial civil and criminal penalties if its communications are deemed to be marketing or promoting its products for "off-label" uses, particularly as the Aquadex System is being used for pediatric patients weighing under the cleared **20 kg**[110](index=110&type=chunk)[112](index=112&type=chunk)[114](index=114&type=chunk) - Changes in U.S. trade policies and tariffs could have a material adverse impact, as the company sources certain raw materials for the Aquadex System from China[118](index=118&type=chunk) - The business is dependent on sole source suppliers, including a single fully validated third-party sterilizer, and any interruption in supply could significantly harm production and business operations[124](index=124&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=24&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) The company reports no unregistered sales of equity securities during the quarter - The company reports no unregistered sales of equity securities for the period[127](index=127&type=chunk) [Item 3. Defaults Upon Senior Securities](index=25&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) The company states this section is not applicable, indicating no defaults on senior securities - The company states that this item is not applicable[128](index=128&type=chunk) [Item 4. Mine Safety Disclosures](index=25&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) The company states this section is not applicable - The company states that this item is not applicable[129](index=129&type=chunk) [Item 5. Other Information](index=25&type=section&id=Item%205.%20Other%20Information) No directors or officers adopted, modified, or terminated Rule 10b5-1 or non-Rule 10b5-1 trading arrangements during the quarter ended March 31, 2025 - No directors or officers adopted, modified, or terminated a Rule 10b5-1 or non-Rule 10b5-1 trading arrangement during the quarter[130](index=130&type=chunk) [Item 6. Exhibits](index=25&type=section&id=Item%206.%20Exhibits) This section lists all exhibits filed with the Quarterly Report on Form 10-Q, including CEO and CFO certifications and Inline XBRL documents - The report includes an exhibit index listing all documents filed with the 10-Q, such as CEO/CFO certifications under Sarbanes-Oxley Sections 302 and 906[131](index=131&type=chunk)[135](index=135&type=chunk)

Revenue and Financial Performance - Revenue for Q1 2025 was $1.9 million, a 3% increase compared to Q1 2024[3] - Gross margin for Q1 2025 was 56.0%, down from 64.1% in the prior-year quarter[4] - Operating loss improved to $3.1 million in Q1 2025, compared to a loss of $4.7 million in Q1 2024[7] - Net loss attributable to common shareholders was $3.0 million, or a loss of $0.69 per share, compared to a net loss of $3.8 million, or $24.11 per share, in the prior-year period[8] Expenses - SG&A expenses decreased by 22% to $3.6 million from $4.6 million in Q1 2024[5] - R&D expenses were $550 thousand, a significant reduction from $1.3 million in the prior-year quarter[7] Cash Position - As of March 31, 2025, cash and cash equivalents were $2.6 million, with no debt[9] Market and Reimbursement - Effective January 1, 2025, CMS increased the outpatient reimbursement rate for Aquadex nearly four-fold to $1,639 per day[6] - The company is focusing on expanding outpatient opportunities driven by favorable reimbursement and clinical data[6] Utilization and Growth - Consumables utilization grew by 4% year-over-year, with pediatric revenue increasing by 38%[6]

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]

Company Performance - Nuwellis, Inc. reported a quarterly loss of $0.69 per share, which was worse than the Zacks Consensus Estimate of a loss of $0.45, representing an earnings surprise of -53.33% [1] - The company posted revenues of $1.9 million for the quarter ended March 2025, missing the Zacks Consensus Estimate by 23.84%, and showing a slight increase from $1.86 million in the same quarter last year [2] - Over the last four quarters, Nuwellis has surpassed consensus EPS estimates only once and has topped consensus revenue estimates just once [2] Stock Performance - Nuwellis shares have declined approximately 10.8% since the beginning of the year, contrasting with the S&P 500's decline of -0.6% [3] - The current Zacks Rank for Nuwellis is 3 (Hold), indicating that the shares are expected to perform in line with the market in the near future [6] Future Outlook - The current consensus EPS estimate for the upcoming quarter is -$0.36 on revenues of $2.65 million, and for the current fiscal year, it is -$1.39 on revenues of $10.87 million [7] - The outlook for the Medical - Instruments industry, where Nuwellis operates, is currently in the top 31% of over 250 Zacks industries, suggesting a favorable environment for stock performance [8]

Revenue for the first quarter of 2025 was $1.9 million, a 3% increase compared to the same period in 2024. The year-over-year increase was driven by a 4% growth in consumables utilization and higher U.S. console sales, partially offset by a decline in international sales. Gross margin for the first quarter of 2025 was 56.0%, compared to 64.1% in the prior-year quarter. The decrease primarily reflects unfavorable manufacturing variances, lower fixed overhead absorption from reduced production, and an invento ...

Strategic agreement is expected to reduce costs, preserve expertise, and streamline operations. | WHO | WHAT | WHERE | WHEN | WHY | | --- | --- | --- | --- | --- | | Nuwellis, Inc. (Nasdaq: NUWE) and KDI | Outsourcing manufacturing and | Manufacturing | May 9, | To strengthen operational efficiency, | | Precision | assembly of key Aquadex product | operations will transition to KDI's facility. | 2025 | preserve product expertise, and reduce | | Manufacturing | components. | | | costs. | MINNEAPOLIS, May 12, ...

Core Viewpoint - Nuwellis, Inc. has expanded its Aquadex SmartFlow therapy into two additional pediatric centers, bringing the total to 47 centers, highlighting a growing recognition of the importance of early and precise fluid management in pediatric care [1][4]. Company Overview - Nuwellis, Inc. is a medical technology company focused on fluid management solutions for patients suffering from fluid overload, particularly in pediatric settings [5]. - The company is headquartered in Minneapolis and has a wholly owned subsidiary in Ireland [5]. Product Details - The Aquadex SmartFlow system is designed for controlled fluid removal in patients weighing 20 kg and above, offering a nurse-managed, bedside-compatible therapy [3][6]. - The system is indicated for temporary or extended use in patients whose fluid overload is unresponsive to medical management, including diuretics [6]. Industry Context - Fluid overload poses significant risks for pediatric patients, making effective management critical for recovery [2]. - The adoption of Aquadex therapy is seen as a proactive measure to prevent complications and improve outcomes in critically ill children [2][4]. Clinical Significance - The expansion of Aquadex therapy into more hospitals indicates a shift in clinical teams' approaches to fluid management, emphasizing the need for early intervention [4]. - The Chief Medical Officer of Nuwellis highlighted the importance of precision in pediatric care, where the margin for error is narrow [3].

Core Viewpoint - Nuwellis, Inc. has received U.S. Patent No. 12,280,007 for a novel self-emptying fluid bag design that enhances nursing workflow and maintains measurement accuracy in fluid management for patients with fluid overload [1][5]. Company Overview - Nuwellis, Inc. is a medical technology company focused on fluid management solutions, particularly for patients suffering from fluid overload [6]. - The company is headquartered in Minneapolis and has a wholly owned subsidiary in Ireland [6]. Patent Details - The patent was officially issued on April 22, 2025, and includes a 224-day extension to its standard term granted by the USPTO [5]. - The patented design features a siphon mechanism that allows the fluid bag to automatically empty without disconnecting from the scale, thus preserving measurement integrity [2]. Impact on Healthcare - Fluid overload is a significant complication in critically ill patients, and the new design aims to improve the accuracy and efficiency of ultrafiltration therapy [3]. - The innovation is expected to simplify routine tasks for clinicians, enhancing both care and workflow in critical care settings [4]. Future Developments - The design may be integrated into future enhancements of the Aquadex SmartFlow system, including a pediatric-focused CRRT device currently under development [4]. - This patent represents a step towards expanding Nuwellis' product portfolio and advancing innovation in fluid management [4]. Product Information - The Aquadex SmartFlow system is indicated for temporary or extended use in adult and pediatric patients weighing 20 kg or more, whose fluid overload is unresponsive to medical management [7]. - Treatments must be administered by trained healthcare providers in clinical settings under physician prescription [7].

Nuwellis, Inc. (Nasdaq: NUWE) is a commercial-stage medical technology company dedicated to transforming the lives of patients suffering from fluid overload through science, collaboration, and innovation. The company is focused on commercializing the Aquadex SmartFlow® system for ultrafiltration therapy. Nuwellis is headquartered in Minneapolis, with a wholly owned subsidiary in Ireland. For more information visit ir.nuwellis.com or visit us on LinkedIn or X. About the Aquadex SmartFlow® System The Aquadex ...