Nuwellis, Inc. Reports Second Quarter 2025 Financial Results and Business Highlights

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 while laying the foundation for expansion in outpatient heart failure. Despite temporary revenue disruption related to an industry-wide sterilization vendor issue, the company took swift action to prioritize patient care, protect its most vulnerable populations, and ensure strong momentum entering the third quarter. Revenue of $1.7 million, compared to $2.2 million in Q2 2024Pediatric category remains a key driver of sustained demandExecuted a transition plan to outsource manufacturing to KDI Precision ManufacturingCompleted a $5 million gross capital raise during the quarterSuccessfully grew to 47 pediatric centers that adopted Aquadex therapy as part of their fluid management approach with the addition of two new centers across the Southeastern United StatesExpanded IP portfolio with granting of new U.S. patent covering the fluid bag design that passively drains once full “While we faced a temporary headwind this quarter due to a vendor issue, our response demonstrated the strength of our operational discipline and our commitment to patients,” said John Erb, Chairman of the Board and CEO of Nuwellis. “We’re entering the second half of the year with clear priorities, a sharpened focus on our core markets, and the confidence that we’re executing on the right strategy to drive long-term growth.” Second Quarter 2025 Financial Results Revenue for the second quarter of 2025 was $1.7 million, compared to $2.2 million in the second quarter of 2024. The year-over-year decline was primarily due to a product backorder caused by an industry-wide sterilization delay. Gross margin was 55.5% in Q2 2025, compared to 67.2% in Q2 2024. The margin contraction was primarily driven by under-absorption of fixed overhead because of lower production volumes. Selling, general and administrative (SG&A) expenses were $3.2 million, which is flat to Q2 2024. Research and development (R&D) expenses totaled $675K, compared to $558K in the same period last year. Total operating expenses for the quarter were $3.9 million, a 2% increase over prior year. Operating loss for the quarter was $2.9 million, compared to $2.3 million in Q2 2024. Net loss attributable to common shareholders was $12.6 million, or a loss of $60.99 per basic and diluted share, compared to $7.7 million, or a loss of $791.82 per share in Q2 2024. As of June 30, 2025, the company had $4.5 million in cash and cash equivalents and remained debt-free. Nuwellis completed a $5.0 million gross capital raise during the quarter. Conference Call and Webcast Information Nuwellis will host a conference call and webcast today at 9:00 AM ET to discuss its first quarter results and recent business developments. To access the live webcast, please visit the Investors page of the Nuwellis website at https://ir.nuwellis.com. Alternatively, participants may dial 1-800-245-3047 (U.S.) or 1-203-518-9765 (International) and use conference ID: NUWEQ2. A replay will be available following the event. About Nuwellis Nuwellis, Inc. (Nasdaq: NUWE) is a commercial-stage medical device company dedicated to transforming the lives of patients suffering from fluid overload through science, collaboration, and innovation. The company’s focus is on commercializing the Aquadex SmartFlow® system for ultrafiltration therapy. Nuwellis is headquartered in Minneapolis, Minnesota, with a wholly owned subsidiary in Ireland. For more information, visit ir.nuwellis.com or follow us on LinkedIn or X. About the Aquadex SmartFlow® System The Aquadex SmartFlow system delivers clinically proven therapy using a simple, flexible, and smart method of removing excess fluid from patients suffering from hypervolemia (fluid overload). The Aquadex SmartFlow system is indicated for temporary (up to 8 hours) or extended (longer than 8 hours in patients who require hospitalization) use in adult and pediatric patients weighing 20 kg or more whose fluid overload is unresponsive to medical management, including diuretics. All treatments must be administered by a healthcare provider within an outpatient or inpatient clinical setting, under physician prescription, both having received training in extracorporeal therapies. Forward-Looking Statements Certain statements in this release may be considered forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including without limitation, statements regarding future growth and market opportunities. Forward-looking statements are based on current assumptions and expectations and involve risks and uncertainties that could cause actual results to differ materially. These risks are detailed in the Company's filings with the Securities and Exchange Commission. Nuwellis undertakes no obligation to update any forward-looking statements, whether as a result of new information, future events, or otherwise. Contacts: Investors:Robert ScottNuwellisChief Financial Officerir@nuwellis.com Media Contact:Leah McMullenNuwellisDirector of CommunicationsLeah.mcmullen@nuwellis.com NUWELLIS, INC. AND SUBSIDIARYCondensed Consolidated Balance Sheets(in thousands, except share and per share amounts) June 30,2025 December 31,2024 (Unaudited) ASSETS Current assets Cash and cash equivalents$4,450 $5,095 Accounts receivable 1,193 1,727 Inventories, net 2,028 1,718 Other current assets 745 315 Total current assets 8,416 8,855 Property, plant and equipment, net 359 478 Operating lease right-of-use asset 404 510 Other assets 21 21 TOTAL ASSETS$9,200 $9,864 LIABILITIES, CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS’ EQUITY (DEFICIT) Current liabilities Accounts payable and accrued liabilities$3,008 $1,640 Accrued compensation 561 640 Current portion of operating lease liability 249 238 Other current liabilities 74 41 Total current liabilities 3,892 2,559 Warrant liabilities 14,074 468 Operating lease liability 189 307 Total liabilities 18,155 3,334 Commitments and contingencies Mezzanine EquitySeries J Convertible Preferred Stock as of June 30, 2025 and December 31, 2024, par value $0.0001 per share; authorized 600,000 shares, issued and outstanding 119 and 102, respectively 5 2 Stockholders’ equity (deficit) Series A junior participating preferred stock as of June 30, 2025 and December 31, 2024, par value $0.0001 per share; authorized 30,000 shares, none outstanding — — Series F convertible preferred stock as of June 30, 2025 and December 31, 2024, par value $0.0001 per share; authorized 18,000 shares, issued and outstanding 27 and 127 shares, respectively — — Series F-1 convertible preferred stock as of June 30, 2025 and December 31, 2024, par value $0.0001 per share; authorized 18,000 shares, issued and outstanding 34 and 0 shares, respectively — — Preferred stock as of June 30, 2025 and December 31, 2024, par value$0.0001 per share; authorized 39,352,000 shares, none outstanding — — Common stock as of June 30, 2025 and December 31, 2024, par value$0.0001 per share; authorized 100,000,000 shares, issued and outstanding527,158 and 104,142, respectively — — Additional paid-in capital 305,452 305,366 Accumulated other comprehensive income: Foreign currency translation adjustment (54) (47)Accumulated deficit (314,358) (298,791)Total stockholders’ equity (deficit) (8,960) 6,528 TOTAL LIABILITIES, CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS’ EQUITY (DEFICIT)$9,200 9,864 NUWELLIS, INC. AND SUBSIDIARYCondensed Consolidated Statements of Operations and Comprehensive Loss (Unaudited)(in thousands, except per share amounts and weighted average shares outstanding) Three months endedJune 30Six months endedJune 30 2025 2024 2025 2024 Net sales$1,725 $2,194 $3,629 $4,051 Cost of goods sold 767 720 1,604 1,386 Gross profit 958 1,474 2,025 2,665 Operating expenses: Selling, general and administrative 3,189 3,236 6,766 7,842 Research and development 675 558 1,225 1,892 Total operating expenses 3,864 3,794 7,991 9,734 Loss from operations (2,906) (2,320) (5,966) (7,069)Other income (expense), net 10 6 17 (95)Financing expense (10,553) (5,607) (10,553) (5,607)Change in fair value of warrant liabilities 900 198 940 720 Loss before income taxes (12,549) (7,723) (15,562) (12,051)Income tax expense (4) (2) (5) (4) Net loss$(12,553) $(7,725) $(15,567) $(12,055)Deemed dividend attributable to Series J Convertible Preferred Stock 1 — 2 541 Net loss attributable to common shareholders$(12,552) $(7,725) $(15,565) $(11,514) Basic and diluted loss per share$(60.99) $(791.82) $(100.44) $(139.74) Weighted average shares outstanding – basic and diluted 205,839 9,755 154,991 86,261 Other comprehensive loss: Net Loss$(12,553) $(7,725) $(15,567) $(12,055)Foreign currency translation adjustments$(5) $(2) $(7) $(11)Total comprehensive loss$(12,558) $(7,727) $(15,574) $(12,066) NUWELLIS, INC. AND SUBSIDIARYCondensed Consolidated Statements of Cash Flows(Unaudited)(in thousands) Six months endedJune 30 2025 2024Operating Activities: Net loss$(15,567) $(12,055)Adjustments to reconcile net loss to cash flows used in operating activities: Depreciation and amortization 123 151 Stock-based compensation expense 84 273 Change in fair value of warrant liabilities (940) (720)Financing expense 10,553 5,607 Changes in operating assets and liabilities: Accounts receivable 534 659 Inventory, net (310) 30 Other current assets (430) (395)Other assets and liabilities 32 5 Accounts payable and accrued expenses 1,288 829 Net cash used in operating activities (4,633) (5,616) Investing Activities: Purchases of property and equipment (4) (53)Net cash used in investing activities (4) (53) Financing Activities: Issuance of common stock and warrants from offering, net 3,999 2,403 Proceeds from the exercise of Series J Convertible Preferred Warrants — 500 Net cash provided by financing activities 3,999 2,903 Effect of exchange rate changes on cash (7) (11)Net decrease in cash and cash equivalents (645) (2,777)Cash and cash equivalents - beginning of period 5,095 3,800 Cash and cash equivalents - end of period$4,450 $1,023 Supplemental cash flow information Issuance of Series J Preferred Stock for exercise of Warrants$— $1,857 Issuance of Common Stock for conversion of Series J Preferred Stock$— $1,535 Issuance of Common Stock for conversion of Series F-1 Preferred Stock$1,100 $— Deemed dividend on Series J Preferred Stock$2 $(541) Common stock offering costs included in prepaids$— $306

Nuwellis, Inc. Reports Second Quarter 2025 Financial Results and Business Highlights

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