Nuwellis(NUWE) - 2025 Q2 - Quarterly Results

Q2 2025 Financial Results and Business Highlights 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 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] - Faced a temporary revenue disruption due to an industry-wide sterilization vendor issue, but took swift action to prioritize patient care[3][4] - Executed a transition plan to outsource manufacturing to KDI Precision Manufacturing[8] - Completed a $5 million gross capital raise during the quarter[8] - Successfully grew to 47 pediatric centers that adopted Aquadex therapy, with the addition of two new centers across the Southeastern United States[8] - Expanded IP portfolio with the granting of a new U.S. patent covering the fluid bag design[8] Q2 2025 Financial Overview 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] - Gross margin contraction was primarily driven by under-absorption of fixed overhead because of lower production volumes[5] Company and Investor Information 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 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] - 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] About Nuwellis 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] - Dedicated to transforming the lives of patients suffering from fluid overload[11] - Focuses on commercializing the Aquadex SmartFlow® system for ultrafiltration therapy[11] About the Aquadex SmartFlow® System 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] - 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] - Applicable to patients whose fluid overload is unresponsive to medical management, including diuretics[12] - Treatments must be administered by a healthcare provider within an outpatient or inpatient clinical setting, under physician prescription, with training in extracorporeal therapies[12] Forward-Looking Statements 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] - 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] - Nuwellis undertakes no obligation to update any forward-looking statements[13] 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] - Media contact: Leah McMullen, Director of Communications (Leah.mcmullen@nuwellis.com)[14] Condensed Consolidated Financial Statements 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 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] - Total stockholders' equity shifted from positive $6,528 thousand to negative $(8,960) thousand[16] Condensed Consolidated Statements of Operations and Comprehensive Loss 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] - Financing expense significantly increased to $(10,553) thousand in Q2 2025 from $(5,607) thousand in Q2 2024[18] - 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] Condensed Consolidated Statements of Cash Flows 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] - 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]