[Q2 2025 Financial Results and Business Highlights](index=1&type=section&id=Q2%202025%20Financial%20Results%20and%20Business%20Highlights) Nuwellis reported Q2 2025 revenue of **$1.7 million**, a decline from **$2.2 million** in Q2 2024, with increased operating and net losses, while strategically realigning its business focus [Q2 2025 Business Highlights](index=1&type=section&id=Second%20Quarter%202025%20and%20Recent%20Business%20Highlights) Nuwellis strategically realigned in Q2 2025, focusing on high-impact growth areas and completing a **$5 million** capital raise despite a temporary revenue disruption - Strategic realignment focused on high-impact growth areas in pediatric and cardiac surgery care, laying the foundation for expansion in outpatient heart failure[3](index=3&type=chunk) - Faced a temporary revenue disruption due to an industry-wide sterilization vendor issue, but took swift action to prioritize patient care[3](index=3&type=chunk)[4](index=4&type=chunk) - Executed a transition plan to outsource manufacturing to KDI Precision Manufacturing[8](index=8&type=chunk) - Completed a **$5 million** gross capital raise during the quarter[8](index=8&type=chunk) - Successfully grew to **47 pediatric centers** that adopted Aquadex therapy, with the addition of two new centers across the Southeastern United States[8](index=8&type=chunk) - Expanded IP portfolio with the granting of a new U.S. patent covering the fluid bag design[8](index=8&type=chunk) [Q2 2025 Financial Overview](index=1&type=section&id=Second%20Quarter%202025%20Financial%20Results) Nuwellis reported Q2 2025 revenue of **$1.7 million**, a decline from **$2.2 million** in Q2 2024, with increased operating and net losses, but maintained a debt-free status Q2 2025 Financial Highlights (in millions, except per share and percentage) | Metric | Q2 2025 ($) | Q2 2024 ($) | Change (YoY) | | :------------------------------------ | :------ | :------ | :----------- | | Revenue | $1.7 | $2.2 | -22.7% | | Gross Margin | 55.5% | 67.2% | -11.7 pp | | SG&A Expenses | $3.2 | $3.2 | 0% | | R&D Expenses | $0.675 | $0.558 | +20.9% | | Total Operating Expenses | $3.9 | $3.794 | +2.8% | | Operating Loss | $(2.9) | $(2.3) | -26.1% | | Net Loss Attributable to Common Shareholders | $(12.6) | $(7.7) | -63.6% | | Basic and Diluted Loss Per Share | $(60.99) | $(791.82) | +92.3% (less negative) | | Cash and Cash Equivalents (as of June 30, 2025) | $4.5 | N/A | N/A | | Debt Status | Debt-free | N/A | N/A | - Revenue decline was primarily due to a product backorder caused by an industry-wide sterilization delay[4](index=4&type=chunk) - Gross margin contraction was primarily driven by under-absorption of fixed overhead because of lower production volumes[5](index=5&type=chunk) [Company and Investor Information](index=2&type=section&id=Company%20and%20Investor%20Information) This section provides details on Nuwellis's corporate profile, the Aquadex SmartFlow® system, investor communication, and forward-looking statement disclaimers [Conference Call and Webcast Information](index=2&type=section&id=Conference%20Call%20and%20Webcast%20Information) Nuwellis hosted a conference call and webcast on August 14, 2025, at 9:00 AM ET to discuss Q2 results and business developments - Conference call and webcast held on August 14, 2025, at 9:00 AM ET to discuss Q2 results and recent business developments[10](index=10&type=chunk) - Access via the Investors page of the Nuwellis website (https://ir.nuwellis.com) or dial-in (1-800-245-3047 U.S. / 1-203-518-9765 International) using conference ID: NUWEQ2[10](index=10&type=chunk) [About Nuwellis](index=2&type=section&id=About%20Nuwellis) Nuwellis, Inc. is a commercial-stage medical device company focused on transforming care for fluid overload patients through the Aquadex SmartFlow® system - Nuwellis, Inc. (Nasdaq: NUWE) is a commercial-stage medical device company[11](index=11&type=chunk) - Dedicated to transforming the lives of patients suffering from fluid overload[11](index=11&type=chunk) - Focuses on commercializing the Aquadex SmartFlow® system for ultrafiltration therapy[11](index=11&type=chunk) [About the Aquadex SmartFlow® System](index=2&type=section&id=About%20the%20Aquadex%20SmartFlow%C2%AE%20System) The Aquadex SmartFlow® system provides clinically proven ultrafiltration therapy for fluid overload in adult and pediatric patients unresponsive to medical management - Delivers clinically proven therapy using a simple, flexible, and smart method of removing excess fluid from patients suffering from hypervolemia (fluid overload)[12](index=12&type=chunk) - Indicated for temporary (up to 8 hours) or extended (longer than 8 hours in hospitalized patients) use in adult and pediatric patients weighing **20 kg** or more[12](index=12&type=chunk) - Applicable to patients whose fluid overload is unresponsive to medical management, including diuretics[12](index=12&type=chunk) - Treatments must be administered by a healthcare provider within an outpatient or inpatient clinical setting, under physician prescription, with training in extracorporeal therapies[12](index=12&type=chunk) [Forward-Looking Statements](index=2&type=section&id=Forward-Looking%20Statements) The release contains forward-looking statements based on current assumptions, involving risks and uncertainties, with no obligation for Nuwellis to update them - Statements in the release may be considered forward-looking, including those regarding future growth and market opportunities[13](index=13&type=chunk) - Forward-looking statements are based on current assumptions and expectations and involve risks and uncertainties detailed in the Company's filings with the Securities and Exchange Commission[13](index=13&type=chunk) - Nuwellis undertakes no obligation to update any forward-looking statements[13](index=13&type=chunk) [Contacts](index=3&type=section&id=Contacts) Contact information for investor relations and media inquiries is provided for Nuwellis, Inc - Investors contact: Robert Scott, Chief Financial Officer (ir@nuwellis.com)[14](index=14&type=chunk) - Media contact: Leah McMullen, Director of Communications (Leah.mcmullen@nuwellis.com)[14](index=14&type=chunk) [Condensed Consolidated Financial Statements](index=4&type=section&id=Condensed%20Consolidated%20Financial%20Statements) This section presents Nuwellis's Q2 2025 condensed consolidated balance sheets, statements of operations, and cash flows, highlighting key financial performance and position metrics [Condensed Consolidated Balance Sheets](index=4&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) As of June 30, 2025, Nuwellis reported total assets of **$9.2 million**, a significant increase in total liabilities to **$18.155 million**, and a shift to negative stockholders' equity Condensed Consolidated Balance Sheet Highlights (in thousands) | Metric | June 30, 2025 ($) | Dec 31, 2024 ($) | Change ($) | | :-------------------------- | :------------ | :----------- | :----- | | Cash and cash equivalents | $4,450 | $5,095 | $(645) | | Total current assets | $8,416 | $8,855 | $(439) | | Total assets | $9,200 | $9,864 | $(664) | | Total current liabilities | $3,892 | $2,559 | $1,333 | | Warrant liabilities | $14,074 | $468 | $13,606 | | Total liabilities | $18,155 | $3,334 | $14,821 | | Total stockholders' equity | $(8,960) | $6,528 | $(15,488) | - Significant increase in warrant liabilities from **$468 thousand** at December 31, 2024, to **$14,074 thousand** at June 30, 2025[16](index=16&type=chunk) - Total stockholders' equity shifted from positive **$6,528 thousand** to negative **$(8,960) thousand**[16](index=16&type=chunk) [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) Nuwellis reported Q2 2025 net sales of **$1.725 million**, a wider operating loss of **$(2.906) million**, and a significantly increased net loss of **$(12.552) million** due to substantial financing expense Q2 2025 and YTD June 30, 2025, Statements of Operations Highlights (in thousands, except per share) | Metric | Three months ended June 30, 2025 ($) | Three months ended June 30, 2024 ($) | Six months ended June 30, 2025 ($) | Six months ended June 30, 2024 ($) | | :--------------------------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Net sales | $1,725 | $2,194 | $3,629 | $4,051 | | Gross profit | $958 | $1,474 | $2,025 | $2,665 | | Total operating expenses | $3,864 | $3,794 | $7,991 | $9,734 | | Loss from operations | $(2,906) | $(2,320) | $(5,966) | $(7,069) | | Financing expense | $(10,553) | $(5,607) | $(10,553) | $(5,607) | | Net loss attributable to common shareholders | $(12,552) | $(7,725) | $(15,565) | $(11,514) | | Basic and diluted loss per share | $(60.99) | $(791.82) | $(100.44) | $(139.74) | - Net sales decreased by **21.3%** for the three months ended June 30, 2025, compared to the same period in 2024[18](index=18&type=chunk) - Financing expense significantly increased to **$(10,553) thousand** in Q2 2025 from **$(5,607) thousand** in Q2 2024[18](index=18&type=chunk) - Basic and diluted loss per share decreased from **$(791.82)** to **$(60.99)** despite a larger net loss, due to a substantial increase in weighted average shares outstanding (from **9,755** to **205,839**)[18](index=18&type=chunk) [Condensed Consolidated Statements of Cash Flows](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) For the six months ended June 30, 2025, Nuwellis saw improved net cash used in operating activities and increased cash from financing, resulting in a **$(645) thousand** net decrease in cash Six Months Ended June 30, 2025, Cash Flow Highlights (in thousands) | Metric | Six months ended June 30, 2025 ($) | Six months ended June 30, 2024 ($) | | :------------------------------------ | :----------------------------- | :----------------------------- | | Net cash used in operating activities | $(4,633) | $(5,616) | | Net cash used in investing activities | $(4) | $(53) | | Net cash provided by financing activities | $3,999 | $2,903 | | Net decrease in cash and cash equivalents | $(645) | $(2,777) | | Cash and cash equivalents - end of period | $4,450 | $1,023 | - Net cash used in operating activities decreased by **17.5%** year-over-year[20](index=20&type=chunk) - Net cash provided by financing activities increased by **37.7%** year-over-year, driven by the issuance of common stock and warrants from offering[20](index=20&type=chunk)

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]

MINNEAPOLIS, Aug. 14, 2025 (GLOBE NEWSWIRE) -- Nuwellis, Inc. (Nasdaq: NUWE), a commercial-stage medical technology company dedicated to transforming care for fluid overload patients, today announced financial results for the second quarter ended June 30, 2025, and provided a business update. Second Quarter 2025 and Recent Business Highlights Nuwellis continued to advance its strategic realignment during the second quarter, sharpening focus on high-impact growth areas in pediatric and cardiac surgery care w ...

Core Viewpoint - Nuwellis, Inc. is exiting international operations to focus exclusively on the U.S. market, where it is experiencing the strongest growth and clinical demand [1][2][3] Company Strategy - The strategic realignment supports Nuwellis' core business strategy of investing in markets that drive revenue growth, particularly in U.S. cardiac surgery and pediatric programs [2][3] - The company aims to streamline operations to prioritize investment in areas with immediate and long-term impact [2][3] Market Focus - Nuwellis is doubling down on the U.S. market, focusing on high-acuity and hospital-based outpatient settings [3] - Cardiac surgery, pediatrics, and outpatient models are identified as the strongest growth drivers, offering faster intervention and better patient outcomes [3] Operational Changes - The company will support its international partners through a structured wind-down period, aligning operations with market demand [4] - This shift emphasizes operational discipline and customer focus to deliver shareholder value [4] Product Information - Nuwellis is dedicated to transforming the lives of patients suffering from fluid overload through its Aquadex SmartFlow® system, which is indicated for ultrafiltration therapy [5][6] - The system is designed for both adult and pediatric patients and is administered in clinical settings under physician supervision [6]

Core Viewpoint - Nuwellis, Inc. has announced a postponement of its 2025 second quarter earnings release and conference call, originally set for August 12, 2025, due to the need for additional time to complete valuations and audit procedures [1] Company Overview - Nuwellis, Inc. is a medical technology company focused on fluid management, specifically targeting patients suffering from fluid overload [3] - The company is headquartered in Minneapolis and has a wholly owned subsidiary in Ireland [3] Product Information - The Aquadex SmartFlow® system is designed for ultrafiltration therapy, providing a clinically proven method to remove excess fluid from patients with hypervolemia [4] - The system is indicated for temporary use (up to 8 hours) or extended use (longer than 8 hours) in adult and pediatric patients weighing 20 kg or more, whose fluid overload is unresponsive to medical management [4] Upcoming Events - A conference call and webcast to discuss financial results and provide a general business update is scheduled for 9:00 AM ET on August 14, 2025 [1]

Core Insights - Nuwellis, Inc. has successfully treated the first patients with Aquadex ultrafiltration therapy in a hospital-based outpatient setting, marking a significant advancement in fluid management access and care [1][2][3] - The transition to outpatient therapy is supported by a recent increase in reimbursement rates, which enhances the economic viability for healthcare systems [3][4] Company Developments - The treatments were conducted at a leading healthcare institution in the southeastern United States, utilizing the Aquadex SmartFlow system and established clinical protocols [2] - Nuwellis is actively collaborating with healthcare providers to develop hospital-based outpatient programs, focusing on training, protocols, and workflow integration [5] Economic Impact - Outpatient reimbursement rates have increased from approximately $413 to $1,639 per treatment day, providing a sustainable model for health systems to manage complex patients and reduce readmissions [3] - The outpatient setting allows for treatment without hospitalization, optimizing resource management for healthcare systems [4] Product Information - The Aquadex SmartFlow system is designed for patients suffering from fluid overload, offering a clinically proven method for fluid removal [7] - The system is indicated for both temporary and extended use in adult and pediatric patients, requiring administration by trained healthcare providers [7]

Core Points - Nuwellis, Inc. announced that stockholders approved all proposals at the Special Meeting, aimed at enhancing financial flexibility and supporting strategic growth [1][2][3] Proposal Summaries - **Warrant Exercise Proposal**: Stockholders approved the issuance of common stock shares through the exercise of warrants from the June 10, 2025 financing, allowing full access to committed capital [1] - **Authorized Shares Increase Proposal**: An amendment was approved to increase the number of authorized shares of common stock from 100 million to 200 million [2] - **Reverse Split Proposal**: Stockholders approved a reverse stock split at a ratio between 1-for-5 and 1-for-70, to be enacted at the Board's discretion for Nasdaq compliance [2] Company Insights - CEO John Erb expressed appreciation for stockholder support, indicating that these approvals are crucial for strengthening the company's capital position and executing long-term strategy [3] - Nuwellis is focused on transforming the lives of patients with fluid overload through its Aquadex SmartFlow® system, which is designed for ultrafiltration therapy [4][5]

Core Insights - Nuwellis, Inc. participated in the Virtual Investor "What's Your Story" Summer Spotlight On-Demand Conference, where CEO John Erb shared his commitment to the company and its development programs [1] - The on-demand video webcast of the conference is accessible on the Virtual Investor website and Nuwellis' own website [2] - Nuwellis is a medical device company focused on addressing fluid overload in patients through innovative solutions, particularly the Aquadex SmartFlow® system for ultrafiltration therapy [3] Company Overview - Nuwellis, Inc. is headquartered in Minneapolis and has a wholly owned subsidiary in Ireland [3] - The company is listed on Nasdaq under the ticker symbol NUWE [3] - Nuwellis aims to transform the lives of patients suffering from fluid overload through science and collaboration [3]

Company Overview - Nuwellis, Inc. is a commercial-stage medical technology company focused on transforming the lives of patients suffering from fluid overload through innovation and collaboration [3] - The company is headquartered in Minneapolis and has a wholly owned subsidiary in Ireland [3] Product Information - Nuwellis is focused on commercializing the Aquadex SmartFlow® system, which is designed for ultrafiltration therapy to remove excess fluid from patients with hypervolemia [3][4] - The Aquadex SmartFlow system is indicated for temporary use (up to 8 hours) or extended use (longer than 8 hours) in adult and pediatric patients weighing 20 kg or more, whose fluid overload is unresponsive to medical management [4] Financial Results Announcement - Nuwellis will release its financial results for the second quarter of 2025 on August 12, 2025 [1] - A conference call and webcast will be held at 9:00 AM ET to discuss the financial results and provide a general business update [1]

Core Insights - Nuwellis, Inc. has announced the termination of its REVERSE-HF clinical trial to focus resources on outpatient markets with higher potential for impact and growth [1][2] - The company aims to redirect investments towards outpatient heart failure, pediatric, and critical care areas, anticipating savings of approximately $4.0 million over the next 2.5 years from this decision [2][3] Company Strategy - The decision to terminate the REVERSE-HF trial is part of a strategic commitment to prioritize areas that demonstrate the greatest potential for patient impact and business growth [1][2] - Nuwellis is experiencing increasing demand for its ultrafiltration therapy in hospital-based outpatient heart failure programs, indicating a shift in focus towards this high-potential area [2] Clinical Trial Details - The REVERSE-HF trial began enrolling patients in 2022 and had enrolled 167 patients at the time of termination [3] - The company plans to collaborate with the steering committee and biostatisticians to derive statistical value from the existing data for future clinical publications [3] Product Information - The Nuwellis SmartFlow device remains on the market as an FDA-cleared treatment for fluid overload, and the termination of the trial was not related to device performance or patient safety concerns [4][6] - The Aquadex SmartFlow system is designed for ultrafiltration therapy, indicated for both adult and pediatric patients suffering from hypervolemia [6]