Fourth Quarter and Recent Highlights:
- Fourth quarter revenue of
$2.4 million , a 4% increase compared to the prior-year quarter and 9% increase sequentially. - 208% increase in
U.S. console sales in Q4 versus prior year quarter. - Heart Failure revenue increased 48% and Pediatrics increased 16% year-over-year in Q4.
- Gross margin of 68.2% in Q4, compared to 58.4% in the prior-year quarter.
- Closed a
$5.0 million private placement and warrant inducement transaction inJanuary 2026 , strengthening the Company's capital position. - Appointed
Carisa Schultz as Chief Financial Officer, effectiveFebruary 2, 2026 . - Executed a definitive stock purchase agreement to acquire Rendiatech, expanding the Company's cardiorenal portfolio.
“2025 was a year of structural change and strategic re-focus for Nuwellis,” said
“Additionally, we are entering 2026 with new momentum,”
Fourth Quarter 2025 Financial Results
Revenue for the fourth quarter of 2025 was
Gross margin for the fourth quarter of 2025 was 68.2%, compared to 58.4% in the prior-year quarter. The gross margin improvement reflects improved pricing and product mix, partially offset by unfavorable manufacturing variances.
Operating expenses for the fourth quarter of 2025 were approximately
Operating loss for the fourth quarter of 2025 was approximately
Net loss attributable to common shareholders for the fourth quarter of 2025 was approximately
Full Year 2025 Financial Results
Revenue for the full year ended
Gross margin as a percent of revenue for the full year was 62.0%, compared to 64.9% in the prior year.
Operating expenses for the full year were
Net loss attributable to common shareholders for the full year was
On
Webcast and Conference Call Information
The Company will host a conference call and webcast at
To access the live webcast, please visit the Investors page of the Nuwellis website at https://ir.nuwellis.com.
Alternatively, you may access the live conference call by dialing 1-800-343-4885 (
For more information, visit www.nuwellis.com.
About Nuwellis
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 health care 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 the new market opportunities and anticipated growth in 2026 and beyond. Forward-looking statements are predictions, projections and other statements about future events that are based on current expectations and assumptions and, as a result, are subject to risks and uncertainties. Many factors could cause actual future events to differ materially from the forward-looking statements in this release, including, without limitation, those risks associated with our ability to execute on our commercialization strategy, the possibility that we may be unable to raise sufficient funds necessary for our anticipated operations, our post-market clinical data collection activities, benefits of our products to patients, our expectations with respect to product development and commercialization efforts, our ability to increase market and physician acceptance of our products, potentially competitive product offerings, intellectual property protection, our ability to integrate acquired businesses, our expectations regarding anticipated synergies with and benefits from acquired businesses, and other risks and uncertainties described in our filings with the
For further information, please contact:
Investor Relations:
ir@nuwellis.com
Media Contact:
Director of Communications
Leah.mcmullen@nuwellis.com
| Condensed Consolidated Balance Sheets (in thousands, except share and per share amounts) | |||||||
2025 | 2024 | ||||||
| ASSETS | |||||||
| Current assets | |||||||
| Cash and cash equivalents | $ | 1,085 | $ | 5,095 | |||
| Accounts receivable | 1,493 | 1,727 | |||||
| Inventories, net | 1,910 | 1,718 | |||||
| Other current assets | 698 | 315 | |||||
| Total current assets | 5,186 | 8,855 | |||||
| Property, plant and equipment, net | 368 | 478 | |||||
| Operating lease right-of-use asset | 293 | 510 | |||||
| Other assets | 271 | 21 | |||||
| TOTAL ASSETS | $ | 6,118 | $ | 9,864 | |||
| LIABILITIES, CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS’ EQUITY | |||||||
| Current liabilities | |||||||
| Accounts payable and accrued liabilities | $ | 2,226 | $ | 1,640 | |||
| Accrued compensation | 460 | 640 | |||||
| Current portion of operating lease liability | 261 | 238 | |||||
| Other current liabilities | 85 | 41 | |||||
| Total current liabilities | 3,032 | 2,559 | |||||
| Warrant liabilities | 389 | 468 | |||||
| Operating lease liability | 67 | 307 | |||||
| Total liabilities | 3,488 | 3,334 | |||||
| Commitments and contingencies | |||||||
| Mezzanine Equity Series J Convertible Preferred Stock as of | 6 | 2 | |||||
| Stockholders’ equity | |||||||
| Series A junior participating preferred stock as of | — | — | |||||
| Series F convertible preferred stock as of | — | — | |||||
| Series F-1 convertible preferred stock as of | — | — | |||||
| Preferred stock as of | — | — | |||||
| Common stock as of 1,686,217 and 104,142, respectively | — | — | |||||
| Additional paid-in capital | 318,928 | 305,366 | |||||
| Accumulated other comprehensive income: | |||||||
| Foreign currency translation adjustment | 8 | (47 | ) | ||||
| Accumulated deficit | (316,312 | ) | (298,791 | ) | |||
| Total stockholders’ equity | 2,624 | 6,528 | |||||
| TOTAL LIABILITIES, CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS’ EQUITY | $ | 6,118 | $ | 9,864 | |||
Condensed Consolidated Statements of Operations and Comprehensive Loss (in thousands, except per share amounts and weighted average shares outstanding) | |||||||||||||||
| Three months ended | Twelve months ended | ||||||||||||||
| 2025 | 2024 | 2025 | 2024 | ||||||||||||
| Net sales | $ | 2,424 | $ | 2,322 | $ | 8,270 | $ | 8,740 | |||||||
| Cost of goods sold | 770 | 967 | 3,146 | 3,064 | |||||||||||
| Gross profit | 1,654 | 1,355 | 5,124 | 5,676 | |||||||||||
| Operating expenses: | |||||||||||||||
| Selling, general and administrative | 3,213 | 2,911 | 13,518 | 13,455 | |||||||||||
| Research and development | 884 | 831 | 2,712 | 3,209 | |||||||||||
| Total operating expenses | 4,097 | 3,742 | 16,230 | 16,664 | |||||||||||
| Loss from operations | (2,443 | ) | (2,387 | ) | (11,106 | ) | (10,988 | ) | |||||||
| Other income (expense), net | (11 | ) | 7 | 10 | (80 | ) | |||||||||
| Gain on settlement | — | 900 | — | 900 | |||||||||||
| Financing expense | — | — | (10,553 | ) | (5,607 | ) | |||||||||
| Change in fair value of warrant liabilities | 32 | 13 | 4,133 | 4,615 | |||||||||||
| Income (loss) before income taxes | (2,422 | ) | (1,467 | ) | (17,516 | ) | (11,160 | ) | |||||||
| Income tax expense | — | (1 | ) | (5 | ) | (5 | ) | ||||||||
| Net income (loss) | $ | (2,422 | ) | $ | (1,468 | ) | $ | (17,521 | ) | $ | (11,165 | ) | |||
| Deemed dividend attributable to Series J Convertible Preferred Stock | 1 | — | 4 | 541 | |||||||||||
| Net income (loss) attributable to common shareholders | $ | (2,421 | ) | $ | (1,468 | ) | $ | (17,517 | ) | $ | (10,624 | ) | |||
| Basic and diluted income (loss) per share | $ | (1.50 | ) | $ | (18.30 | ) | $ | (25.39 | ) | $ | (353.30 | ) | |||
| Weighted average shares outstanding – basic and diluted | 1,614,214 | 80,015 | 690,145 | 31,601 | |||||||||||
| Other comprehensive loss: | |||||||||||||||
| Net income (loss) | $ | (2,422 | ) | $ | (1,468 | ) | $ | (17,521 | ) | $ | (11,165 | ) | |||
| Foreign currency translation adjustments | $ | 62 | $ | (1 | ) | $ | 55 | $ | (16 | ) | |||||
| Total comprehensive income (loss) | $ | (2,360 | ) | $ | (1,469 | ) | $ | (17,466 | ) | $ | (11,181 | ) | |||
| Condensed Consolidated Statements of Cash Flows (in thousands) | |||||||
| Twelve months ended | |||||||
| 2025 | 2024 | ||||||
| Operating Activities: | |||||||
| Net loss | $ | (17,521 | ) | $ | (11,165 | ) | |
| Adjustments to reconcile net loss to cash flows used in operating activities: | |||||||
| Depreciation and amortization | 200 | 310 | |||||
| Stock-based compensation expense | 127 | 478 | |||||
| Change in fair value of warrant liabilities | (4,133 | ) | (4,615 | ) | |||
| Loss on disposal of intangible asset | — | 99 | |||||
| Financing expense | 10,553 | 5,607 | |||||
| Amortization of operating lease right-of-use asset | 217 | — | |||||
| Changes in operating assets and liabilities: | |||||||
| Accounts receivable | 234 | 224 | |||||
| Inventory, net | (192 | ) | 279 | ||||
| Other current assets | (528 | ) | (160 | ) | |||
| Other assets and liabilities | (173 | ) | (22 | ) | |||
| Accounts payable and accrued expenses | 406 | (626 | ) | ||||
| Net cash used in operating activities | (10,810 | ) | (9,591 | ) | |||
| Investing Activities: | |||||||
| Purchases of property and equipment | (90 | ) | (60 | ) | |||
| Net cash used in investing activities | (90 | ) | (60 | ) | |||
| Financing Activities: | |||||||
| Issuance of common stock and warrants from offering, net | 3,999 | 2,403 | |||||
| Issuance of common stock from ATM, net | 2,941 | — | |||||
| Proceeds from the exercise of Series J Convertible Preferred Warrants | — | 501 | |||||
| Proceeds from the exercise of | — | 2,246 | |||||
| Issuance of July and | — | 2,160 | |||||
| Proceeds from warrant inducement in | — | 3,364 | |||||
| Proceeds from the exercise of warrants, net | — | 288 | |||||
| Net cash provided by financing activities | 6,940 | 10,962 | |||||
| Effect of exchange rate changes on cash | 55 | (16 | ) | ||||
| Net decrease in cash, cash equivalents and restricted cash | (3,905 | ) | 1,295 | ||||
| Cash, cash equivalents and restricted cash - beginning of period | 5,095 | 3,800 | |||||
| Cash, cash equivalents and restricted cash - end of period | $ | 1,190 | $ | 5,095 | |||
| Supplemental schedule of non-cash activities | |||||||
| Reclassification of | $ | — | $ | 4,217 | |||
| Issuance of Series J Preferred Stock for exercise of Warrants | $ | — | $ | 1,857 | |||
| Series A warrants conversion to equity | $ | 8,440 | $ | — | |||
| Series B warrant exercises | $ | 2,055 | $ | — | |||
| 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 | $ | 4 | $ | 541 | |||
| Supplemental cash flow information | |||||||
| Cash paid for income taxes | $ | 7 | $ | 7 |
Source: