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

Rhea-AI Summary

Nuwellis (Nasdaq: NUWE) reported Q2 2025 financial results, with revenue declining to $1.7 million from $2.2 million in Q2 2024, primarily due to industry-wide sterilization vendor issues. The company's gross margin contracted to 55.5% from 67.2% year-over-year.

Key developments include expanding to 47 pediatric centers, completing a $5 million gross capital raise, and executing a manufacturing outsourcing plan to KDI Precision Manufacturing. The company reported a net loss of $12.6 million, or $60.99 per share, compared to $7.7 million loss in Q2 2024. As of June 30, 2025, Nuwellis maintained $4.5 million in cash and remained debt-free.

Positive

• Expansion to 47 pediatric centers with two new additions in the Southeast US
• Successful completion of $5 million gross capital raise
• New U.S. patent granted for fluid bag design
• Company remains debt-free
• Strategic manufacturing outsourcing to KDI Precision Manufacturing

Negative

• Revenue declined 22.7% to $1.7 million year-over-year
• Gross margin contracted significantly from 67.2% to 55.5%
• Operating loss increased to $2.9 million from $2.3 million
• Net loss widened to $12.6 million from $7.7 million year-over-year
• Production disruption due to sterilization vendor issues

Insights

Financial Analyst

Nuwellis reported declining revenue and margins due to sterilization issues, with continued cash burn despite operational restructuring efforts.

Nuwellis's Q2 2025 results reveal significant financial challenges, with revenue declining 22.7% year-over-year to $1.7 million, primarily due to product backorders from an industry-wide sterilization vendor issue. This operational disruption manifested in both top-line pressure and margin deterioration, with gross margin contracting substantially from 67.2% to 55.5% due to lower production volumes and fixed cost under-absorption.

The company's cash position stands at $4.5 million after completing a $5 million capital raise during the quarter, indicating substantial cash burn continuing through operations. With operating losses widening to $2.9 million from $2.3 million in Q2 2024 and net losses ballooning to $12.6 million, the company's burn rate remains a critical concern despite being debt-free.

Strategically, Nuwellis is pivoting toward higher-potential market segments, particularly pediatric care and cardiac surgery, while setting groundwork for expansion in outpatient heart failure treatment. The addition of two new pediatric centers (bringing the total to 47) demonstrates modest traction in this focus area. The company has also outsourced manufacturing to KDI Precision Manufacturing, likely to reduce fixed costs and improve operational flexibility.

While management frames the revenue decline as temporary, the significant margin compression and widening losses suggest structural challenges beyond just the sterilization delay. The stark increase in net loss per share (from $791.82 to $60.99) reflects substantial shareholder dilution from the recent capital raise, which investors should carefully consider alongside the company's path to profitability.

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 2024
• Pediatric category remains a key driver of sustained demand
• Executed a transition plan to outsource manufacturing to KDI Precision Manufacturing
• Completed a $5 million gross capital raise during the quarter
• Successfully 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 States
• Expanded 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 Scott
Nuwellis
Chief Financial Officer
ir@nuwellis.com

Media Contact:
Leah McMullen
Nuwellis
Director of Communications
Leah.mcmullen@nuwellis.com

NUWELLIS, INC. AND SUBSIDIARY Condensed 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 Equity Series 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 outstanding 527,158 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 SUBSIDIARY Condensed Consolidated Statements of Operations and Comprehensive Loss (Unaudited) (in thousands, except per share amounts and weighted average shares outstanding)
		Three months ended June 30							Six months ended June 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 SUBSIDIARY Condensed Consolidated Statements of Cash Flows (Unaudited) (in thousands)
		Six months ended June 30
		2025				2024
Operating 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

FAQ

What were Nuwellis (NUWE) Q2 2025 earnings results?

Nuwellis reported Q2 2025 revenue of $1.7 million, down from $2.2 million in Q2 2024, with a net loss of $12.6 million or $60.99 per share.

How much cash does Nuwellis (NUWE) have as of Q2 2025?

As of June 30, 2025, Nuwellis had $4.5 million in cash and cash equivalents and remained debt-free.

What caused Nuwellis (NUWE) revenue decline in Q2 2025?

The revenue decline was primarily due to a product backorder caused by an industry-wide sterilization delay affecting vendor operations.

How many pediatric centers use Nuwellis (NUWE) Aquadex therapy?

Nuwellis has expanded to 47 pediatric centers that have adopted Aquadex therapy, adding two new centers across the Southeastern United States.

What strategic changes did Nuwellis (NUWE) implement in Q2 2025?

Nuwellis executed a transition plan to outsource manufacturing to KDI Precision Manufacturing and completed a $5 million gross capital raise.