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

1. NUWE reported Q1 2025 revenue growth of 3% year-over-year. 2. Significant pediatric revenue growth of 38% supports business trends. 3. Higher CMS reimbursement boosts outpatient facility fees for Aquadex. 4. Operating expenses reduced by 31%, improving financial health. 5. NUWE holds $2.6 million in cash, remaining debt-free.

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$0.964505/14 02:01 PM EDTLatest Updated
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FAQ

Why Bullish?

The positive revenue growth and expense management indicate potential future profitability, similar to firms that rebound after improving financial metrics.

How important is it?

Financial improvements and strategic priorities suggest potential for stock price increases.

Why Short Term?

Immediate effects from increased revenue and reimbursement can influence investor sentiment soon.

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CMSAKTXNXSTCARR
May 13, 2025 07:00 ET  | Source: Nuwellis, Inc. MINNEAPOLIS, May 13, 2025 (GLOBE NEWSWIRE) -- Nuwellis, Inc. (Nasdaq: NUWE), a commercial-stage medical device company dedicated to transforming care for fluid overload patients, today announced financial results for the first quarter ended March 31, 2025, and provided a business update. First Quarter 2025 and Recent Business Highlights Nuwellis continued to advance its strategic priorities during the first quarter, delivering growth in customer categories and strengthening the foundation for broader adoption of Aquadex therapy. Higher CMS reimbursement, strong pediatric performance, and disciplined expense management position the company to capitalize on both inpatient growth and emerging outpatient opportunities in 2025. Revenue of $1.9 million, a 3% increase over the prior-year quarter.4% growth in consumables utilization year-over-year.Pediatric revenue grew 38% year-over-year.Operating expense reduction of $1.8 million, or 31%, compared to the prior-year quarter.Effective January 1, 2025, CMS reassigned Aquadex to a higher outpatient reimbursement level, increasing the facility fee nearly four-fold to $1,639 per day.Expanded outpatient opportunity pipeline, driven by favorable reimbursement and supportive clinical data. "We are encouraged by the strategic progress we’re making in expanding access to Aquadex therapy, particularly as more hospitals explore outpatient use," said John Erb, Chairman of the Board and Interim Chief Executive Officer of Nuwellis. "With higher reimbursement rates now in effect and a growing base of clinical support, we believe we are well-positioned to expand adoption across both inpatient and outpatient environments in 2025." First Quarter 2025 Financial Results 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 inventory adjustment related to the FlexFlow console. Selling, general, and administrative (SG&A) expenses for the first quarter of 2025 were $3.6 million, representing a 22% decrease from $4.6 million in the prior-year period, largely driven by lower headcount, compensation-related expenses, and reduced professional services. Research and development (R&D) expenses were $550 thousand, compared to $1.3 million in the prior-year quarter, primarily due to reduced staffing and lower R&D project spend. Total operating expenses for the quarter were $4.1 million, a 31% decrease from $5.9 million in the first quarter of 2024. Operating loss improved to $3.1 million in the first quarter of 2025, compared to an operating loss of $4.7 million in the first quarter of 2024. Net loss attributable to common shareholders was $3.0 million, or a loss of $0.69 per basic and diluted share, compared to a net loss of $3.8 million, or $24.11 per share, in the prior-year period. As of March 31, 2025, Nuwellis had $2.6 million in cash and cash equivalents and remained debt-free. 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 1-800-579-2543 (U.S.) or 1-785-424-1789 (International) and use conference ID: NUWEQ1. 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:Louisa SmithGilmartin Groupir@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)  March 31, 2025  December 31, 2024    (Unaudited)     ASSETS       Current assets               Cash and cash equivalents             $2,557  $5,095           Accounts receivable 1,540   1,727            Inventories, net 1,752   1,718           Other current assets 274   315   Total current assets 6,123   8,855           Property, plant and equipment, net 405   478           Operating lease right-of-use asset 457   510           Other assets 21   21   TOTAL ASSETS$ 7,006 $9,864           LIABILITIES, CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS’ EQUITY       Current liabilities                 Accounts payable and accrued liabilities$1,731  $1,640             Accrued compensation 689   640             Current portion of operating lease liability 243   238             Other current liabilities 86   41   Total current liabilities 2,749   2,559     Common stock warrant liability 426   468             Operating lease liability 249   307   Total liabilities 3,424  3,334    Commitments and contingencies               Mezzanine EquitySeries J Convertible Preferred Stock as of March 31, 2025 and December 31, 2024, par value $0.0001 per share; authorized 600,000 shares, issued and outstanding 110 and 102, respectively        4         2   Stockholders’ equity       Series A junior participating preferred stock as of March 31, 2025 and December 31, 2024, par value $0.0001 per share; authorized 30,000 shares, none outstanding —   —   Series F convertible preferred stock as of March 31, 2025 and December 31, 2024, par value $0.0001 per share; authorized 18,000 shares, issued and outstanding 127 shares —  —   Preferred stock as of March 31, 2025 and December 31, 2024, par value$0.0001 per share; authorized 39,352,000 shares, none outstanding                 —                   —    Common stock as of March 31, 2025 and December 31, 2024, par value$0.0001 per share; authorized 100,000,000 shares, issued and outstanding4,373,968 and 4,373,968, respectively                                 —                  —   Additional paid‑in capital 305,432  305,366   Accumulated other comprehensive income:            Foreign currency translation adjustment (49)  (47)  Accumulated deficit (301,805)  (298,791)  Total stockholders’ equity 3,578   6,528   TOTAL LIABILITIES, CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS’ EQUITY$7,006  $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 endedMarch 31   2025  2024   Net sales$1,904  $1,857   Cost of goods sold 837   666   Gross profit 1,067   1,191   Operating expenses:       Selling, general and administrative 3,577   4,606   Research and development 550   1,334   Total operating expenses 4,127   5,940   Loss from operations (3,060)  (4,749) Other income (expense), net 7   (101)  Change in fair value of warrant liability 40   522   Loss before income taxes (3,013)  (4,328) Income tax expense (1)  (2) Net loss (3,014)  (4,330) Deemed dividend attributable to Series J Convertible    Preferred Stock 1   541   Net loss attributable to common shareholders$(3,013) $(3,789)         Basic and diluted loss per share$(0.69) $(24.11)         Weighted average shares outstanding – basic and diluted 4,373,968   179,608           Other comprehensive loss:       Net loss$(3,014) $(4,330)   Foreign currency translation adjustments (2)  (9) Total comprehensive loss$(3,016) $(4,339)   NUWELLIS, INC. AND SUBSIDIARYCondensed Consolidated Statements of Cash Flows(Unaudited)(in thousands)   Three months endedMarch 31    2025   2024    Operating Activities:        Net loss$(3,014) $(4,330)   Adjustments to reconcile net loss to cash flows used in operating activities:             Depreciation and amortization 73   76          Stock-based compensation expense 67   158    Change in fair value of warrant liability (40)  (522)   Changes in operating assets and liabilities:             Accounts receivable 187   725         Inventory, net (34)     (134)        Other current assets 41   21         Other assets and liabilities 45     (6)        Accounts payable and accrued expenses 139     1,150    Net cash used in operating activities (2,536)  (2,862)            Investing Activities:           Purchases of property and equipment —    (29)   Net cash used in investing activities —    (29)            Financing Activities:            Proceeds from the exercise of Series J Convertible Preferred Warrants —    500    Net cash provided by financing activities —        500             Effect of exchange rate changes on cash (2)   (9)   Net decrease in cash and cash equivalents (2,538)   (2,400)   Cash and cash equivalents - beginning of period 5,095   3,800     Cash and cash equivalents – end of period$                    2,557  $       1,400              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         Deemed dividend on Series J Preferred Stock$1 $ 541   

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