Nuwellis, Inc. Reports First Quarter 2025 Financial Results and Business Highlights
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 $2.6 million in cash and cash equivalents and remained debt-free.
Conference Call and Webcast Information
Nuwellis will host a conference call and webcast today at 9:00 AM ET to discuss its first quarter results and recent business developments.
To access the live webcast, please visit the Investors page of the Nuwellis website at https://ir.nuwellis.com. Alternatively, participants may dial 1-800-579-2543 (U.S.) or 1-785-424-1789 (International) and use conference ID: NUWEQ1. A replay will be available following the event.
About Nuwellis
Nuwellis, Inc. (Nasdaq: NUWE) is a commercial-stage medical device company dedicated to transforming the lives of patients suffering from fluid overload through science, collaboration, and innovation. The company's focus is on commercializing the Aquadex SmartFlow$(R)$ 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(R) 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 Smith
Gilmartin Group
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)
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 Equity
Series 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 outstanding
4,373,968 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 SUBSIDIARY
Condensed Consolidated Statements of Operations and
Comprehensive Loss
(Unaudited)
(in thousands, except per share amounts and weighted
average shares outstanding)
Three months ended
March 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 SUBSIDIARY
Condensed Consolidated Statements of Cash Flows
(Unaudited)
(in thousands)
Three months ended
March 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
(END) Dow Jones Newswires
May 13, 2025 07:00 ET (11:00 GMT)
Disclaimer: Investing carries risk. This is not financial advice. The above content should not be regarded as an offer, recommendation, or solicitation on acquiring or disposing of any financial products, any associated discussions, comments, or posts by author or other users should not be considered as such either. It is solely for general information purpose only, which does not consider your own investment objectives, financial situations or needs. TTM assumes no responsibility or warranty for the accuracy and completeness of the information, investors should do their own research and may seek professional advice before investing.