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Nuwellis (NUWE)
NASDAQ:NUWE

Nuwellis (NUWE) AI Stock Analysis

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Nuwellis

(NASDAQ:NUWE)

Rating:45Neutral
Price Target:
$0.50
▲(78.57%Upside)
Nuwellis' overall stock score reflects significant financial challenges, including ongoing losses and negative cash flow, as the most critical factors. Technical indicators suggest bearish momentum, and valuation remains unattractive due to a negative P/E ratio. However, cautious optimism from the earnings call and recent strategic agreements provide some positive outlook.
Positive Factors
Pediatric Revenue
Strong growth in Pediatric revenue, up 28% year-over-year, following the addition of three new accounts during the quarter.
Reimbursement
The CMS will reassign the Aquadex ultrafiltration code to increase reimbursement rates, which should provide a profitable reimbursement pathway and expand the number of patients who can receive the therapy.
Revenue Growth
The slight revenue beat in 2Q24 is a positive sign that the company is expanding its presence within the medical system and driving increased utilization of consumables.
Negative Factors
Cash Flow
Even with the higher reimbursement rates, the company is not expected to operate on a positive cash flow basis through at least 2026.
Pediatric Utilization
The y/y decline in the quarter in pediatric utilization gives some concern.
Profitability
The timeline towards profitability remains unclear, likely requiring additional dilutive capital raises, which dampens the investment outlook.

Nuwellis (NUWE) vs. SPDR S&P 500 ETF (SPY)

Nuwellis Business Overview & Revenue Model

Company DescriptionNuwellis, Inc., a medical device company, focuses on developing, manufacturing, and commercializing medical devices used in ultrafiltration therapy. The company's products are the Aquadex FlexFlow and Aquadex SmartFlow systems, which are indicated for the treatment of patients suffering from fluid overload who have failed diuretics. Its Aquadex FlexFlow system includes a console, disposable blood set, and catheter. The company sells its products to hospitals and clinics through its direct salesforce in the United States; and through independent specialty distributors primarily in Austria, Brazil, Czech Republic, Germany, Greece, Hong Kong, India, Israel, Italy, Romania, Singapore, Slovakia, Spain, Switzerland, Thailand, the United Arab Emirates, and the United Kingdom. The company was formerly known as CHF Solutions, Inc. and changed its name to Nuwellis, Inc. in April 2021. Nuwellis, Inc. was founded in 1999 and is headquartered in Eden Prairie, Minnesota.
How the Company Makes MoneyNuwellis generates revenue primarily through the sale and leasing of its Aquadex FlexFlow System and related consumables. The system is marketed to hospitals, clinics, and healthcare providers, who purchase or lease the equipment to treat patients with fluid overload conditions. Additionally, Nuwellis earns income from the sale of disposable items required for the operation of the Aquadex system, such as catheters and filters. The company may also engage in strategic partnerships with healthcare organizations to expand the reach and adoption of its products, contributing to its revenue streams.

Nuwellis Earnings Call Summary

Earnings Call Date:May 13, 2025
(Q1-2025)
|
% Change Since: -71.72%|
Next Earnings Date:Aug 12, 2025
Earnings Call Sentiment Neutral
The earnings call presented a mixed picture with both positive and negative aspects. There were notable achievements in revenue growth and cost management, particularly in the pediatrics and heart failure segments, and improved reimbursement rates that could drive future growth. However, challenges remain with a significant decline in critical care sales and reduced gross margins, alongside issues in international sales. The sentiment leans towards a cautious optimism, with progress counterbalanced by current challenges.
Q1-2025 Updates
Positive Updates
Revenue Growth
Nuwellis generated $1.9 million in revenue for Q1 2025, representing a 3% increase year-over-year, supported by a 4% increase in consumables utilization and an increase in U.S. console sales.
Strong Growth in Pediatrics and Heart Failure
Pediatrics and heart failure segments saw 38% and 28% growth over the prior year, respectively, driven by an increase in consumable utilization.
Reduction in Operating Expenses
Operating expenses reduced by 31% compared to Q1 2024, with selling, general and administrative expenses down by 22% and research and development expenses down by 57.7%.
Improved Reimbursement Coverage
Effective January 1, Aquadex was reassigned to a new outpatient reimbursed level by CMS, increasing the facility reimbursement fee by nearly 4x to $1,639 per day.
Reduction in Net Loss
Net loss attributable to common shareholders was reduced to $3 million or a loss of $0.69 per share compared to a net loss of $3.8 million or $24.11 per share in Q1 2024.
Negative Updates
Decline in Critical Care Sales
Sales in the critical care category decreased by 25% compared to the prior year, primarily due to one of the largest customers acquiring excess inventory at the end of 2024.
Decrease in Gross Margin
Gross margin for Q1 2025 was 56%, down from 64.1% in the same period last year, mainly due to unfavorable manufacturing variances and lower fixed overhead absorption.
Challenges in International Sales
The revenue growth was partially offset by a decrease in international sales.
Company Guidance
During the first quarter of 2025, Nuwellis reported $1.9 million in revenue, marking a 3% year-over-year increase, driven by a 4% rise in consumables utilization and increased U.S. console sales, despite a decrease in international sales. The company saw significant growth in the pediatrics and heart failure segments, with revenues increasing by 38% and 28% respectively, compared to the previous year. However, critical care sales declined by 25% due to a major customer acquiring excess inventory in late 2024. The gross margin fell to 56% from 64.1% a year earlier, primarily due to unfavorable manufacturing variances and inventory adjustments. Operating expenses decreased by 31%, from $4.6 million to $3.6 million, resulting in an operating loss of $3.1 million, an improvement from a $4.7 million loss in the first quarter of 2024. Net loss attributable to common shareholders was $3 million or $0.69 per share, compared to $3.8 million or $24.11 per share in the same period last year. Nuwellis ended the quarter with $2.6 million in cash and no debt, focusing on disciplined expense management and strategic growth initiatives, particularly in the pediatric and outpatient heart failure markets.

Nuwellis Financial Statement Overview

Summary
Nuwellis faces significant financial challenges marked by consistent losses and negative cash flows, despite stable revenue and a strong equity position. The company needs to focus on improving operational efficiency and profitability to ensure long-term sustainability. The medical equipment and supplies industry is competitive, and achieving positive cash flow is critical for future growth and stability.
Income Statement
45
Neutral
Nuwellis demonstrates modest revenue growth with a 2.8% increase from 2022 to 2023 and a slight decline of 1.4% in 2024. However, the company is grappling with negative profitability as evidenced by significant negative EBIT and net income margins. Despite a decent gross profit margin of approximately 64.9% for 2024, ongoing losses due to high operational costs are concerning.
Balance Sheet
50
Neutral
The company's balance sheet shows a healthy equity position with an equity ratio of 66.2% in 2024, indicating a strong buffer against liabilities. However, the debt-to-equity ratio stands at 0.08, showcasing manageable leverage but returns on equity remain negative due to sustained net losses. The stability is commendable, yet profitability remains a critical issue.
Cash Flow
40
Negative
Cash flow analysis reflects a challenging situation with negative free cash flow, although there is a marked improvement in operating cash flow from 2023 to 2024. The company's reliance on financing activities for liquidity is evident. Free cash flow growth remains negative, indicating ongoing cash burn issues which could impact future operations if not addressed.
Breakdown
TTMDec 2024Dec 2023Dec 2022Dec 2021Dec 2020
Income StatementTotal Revenue
8.79M8.74M8.86M8.54M7.92M7.44M
Gross Profit
5.55M5.68M4.98M4.75M4.49M4.06M
EBIT
-9.30M-10.99M-17.63M-17.17M-19.53M-17.03M
EBITDA
-8.02M-5.24M-16.36M-4.90M-19.06M-16.65M
Net Income Common Stockholders
-9.85M-10.62M-20.21M-14.53M-19.58M-15.84M
Balance SheetCash, Cash Equivalents and Short-Term Investments
2.56M5.09M3.80M18.31M24.20M14.44M
Total Assets
7.01M9.86M9.77M24.67M30.42M20.01M
Total Debt
492.00K545.00K760.00K984.00K1.18M339.00K
Net Debt
-2.06M-4.55M-3.04M-16.75M-7.57M-14.10M
Total Liabilities
3.42M3.33M6.56M12.32M4.47M3.69M
Stockholders Equity
3.58M6.53M3.21M12.36M25.95M16.32M
Cash FlowFree Cash Flow
-9.30M-9.65M-18.18M-15.27M-18.06M-16.87M
Operating Cash Flow
-9.27M-9.59M-17.94M-15.15M-17.84M-16.57M
Investing Cash Flow
-31.00K-60.00K330.00K14.73M-15.72M-267.00K
Financing Cash Flow
10.46M10.96M3.68M9.42M27.87M30.02M

Nuwellis Technical Analysis

Technical Analysis Sentiment
Negative
Last Price0.28
Price Trends
50DMA
0.84
Negative
100DMA
1.02
Negative
200DMA
1.20
Negative
Market Momentum
MACD
-0.18
Positive
RSI
24.06
Positive
STOCH
15.60
Positive
Evaluating momentum and price trends is crucial in stock analysis to make informed investment decisions. For NUWE, the sentiment is Negative. The current price of 0.28 is below the 20-day moving average (MA) of 0.70, below the 50-day MA of 0.84, and below the 200-day MA of 1.20, indicating a bearish trend. The MACD of -0.18 indicates Positive momentum. The RSI at 24.06 is Positive, neither overbought nor oversold. The STOCH value of 15.60 is Positive, not indicating any strong overbought or oversold conditions. Overall, these indicators collectively point to a Negative sentiment for NUWE.

Nuwellis Risk Analysis

Nuwellis disclosed 37 risk factors in its most recent earnings report. Nuwellis reported the most risks in the "Finance & Corporate" category.
Finance & Corporate - Financial and accounting risks. Risks related to the execution of corporate activity and strategy
Latest Risks Added 0 New Risks

Nuwellis Peers Comparison

Overall Rating
UnderperformOutperform
Sector (54)
Financial Indicators
Name
Overall Rating
Market Cap
P/E Ratio
ROE
Dividend Yield
Revenue Growth
EPS Growth
54
Neutral
$5.37B3.26-45.10%3.30%16.81%0.02%
49
Neutral
$4.60M-136.26%9.57%10.03%
45
Neutral
$1.33M-440.77%-1.21%93.72%
43
Neutral
$4.67M-496.27%-16.79%-3.69%
42
Neutral
$8.20M-155.20%9.90%94.56%
40
Underperform
$3.61M-145.09%-10.29%
37
Underperform
$6.01M-120.16%-7.74%93.25%
* Healthcare Sector Average
Performance Comparison
Ticker
Company Name
Price
Change
% Change
NUWE
Nuwellis
0.28
-6.20
-95.68%
SINT
Sintx Technologies
3.27
-2.79
-46.04%
RSLS
ReShape Lifesciences
2.52
-295.89
-99.16%
VERO
Venus Concept
2.51
-6.74
-72.86%
VTAK
Catheter Precision
0.36
-4.84
-93.08%
AMIX
Autonomix Medical, Inc.
1.30
-25.70
-95.19%

Nuwellis Corporate Events

Private Placements and FinancingRegulatory Filings and Compliance
Nuwellis Completes Securities Exchange Agreement with CEO
Neutral
Jun 9, 2025

On June 6, 2025, Nuwellis, Inc. filed a Certificate of Designation for Series F-1 Convertible Preferred Stock with the Delaware Secretary of State, authorizing the issuance of 100 shares. This new stock series is similar to the existing Series F Convertible Preferred Stock but includes a conversion limitation to prevent holders from exceeding 19.99% ownership of outstanding common stock. On June 9, 2025, Nuwellis entered into a Securities Exchange Agreement with CEO John L. Erb, exchanging 100 shares of the new Series F-1 Stock for the same number of existing Series F Stock, resulting in Mr. Erb owning 100% of the Series F-1 Stock.

The most recent analyst rating on (NUWE) stock is a Buy with a $17.00 price target. To see the full list of analyst forecasts on Nuwellis stock, see the NUWE Stock Forecast page.

Delistings and Listing ChangesExecutive/Board ChangesShareholder MeetingsStock Split
Nuwellis Approves Reverse Stock Split at Meeting
Neutral
May 22, 2025

On May 20, 2025, Nuwellis held its annual stockholders meeting where key decisions were made. Two Class III directors were elected to the board for three-year terms, and a reverse stock split was approved to help maintain compliance with Nasdaq listing requirements. Additionally, Baker Tilly US, LLP was ratified as the independent public accounting firm for 2025, and provisions were made for potential adjournments to gather more proxy votes if needed.

The most recent analyst rating on (NUWE) stock is a Buy with a $17.00 price target. To see the full list of analyst forecasts on Nuwellis stock, see the NUWE Stock Forecast page.

Product-Related AnnouncementsBusiness Operations and Strategy
Nuwellis Enters Agreement with Kluge Design for Aquadex
Positive
May 12, 2025

On May 9, 2025, Nuwellis, Inc. entered into a Supply & Quality Agreement with Kluge Design, LLC to manufacture and service the Aquadex product line. This agreement, which includes an upfront payment and volume-based payments, involves transferring certain employees to Kluge Design and has an initial term of three years, with automatic renewals. The agreement’s impact includes securing manufacturing capabilities for Nuwellis and ensuring the continuity of their product line, potentially strengthening their position in the medical device industry.

The most recent analyst rating on (NUWE) stock is a Buy with a $17.00 price target. To see the full list of analyst forecasts on Nuwellis stock, see the NUWE Stock Forecast page.

Product-Related AnnouncementsBusiness Operations and Strategy
Nuwellis Highlights Strategic Shift to Critical Care
Positive
Apr 3, 2025

On April 3, 2025, Nuwellis, Inc. announced an updated corporate presentation highlighting strategic shifts towards critical care and pediatrics, which now constitute 80% of their sales. The company is capitalizing on increased reimbursement rates for outpatient care, making their Aquadex therapy more financially viable for hospitals. This shift is expected to reduce long-term healthcare costs, improve patient outcomes, and strengthen Nuwellis’s market position by enhancing the integration of cardiology and nephrology in fluid management.

Glossary
BuyA stock rated as a "Buy" is expected to perform better than the overall market or a specific benchmark over the near-to-medium term. This rating suggests the stock is likely to deliver higher returns compared to other stocks in the same sector or market index. Note: This is not investment advice; please consult a financial advisor before making investment decisions.
HoldA stock rated as a "Hold" is expected to perform in line with the overall market or a specific benchmark. This rating indicates that the stock is neither particularly compelling nor unfavorable for investment. Note: This is not investment advice; please consult a financial advisor before making investment decisions.
SellA stock rated as a "Sell" is expected to perform worse than the overall market or a specific benchmark over the near-to-medium term. This rating suggests the stock may deliver lower returns compared to other stocks in the same sector or market index. Note: This is not investment advice; please consult a financial advisor before making investment decisions.

Disclaimer

This AI Analyst Stock Report is automatically generated by our AI systems using advanced algorithms and publicly available financial, technical, and market data. While the information provided aims to be accurate and insightful, it is intended for informational purposes only and should not be considered financial advice. Any content created by an AI (Artificial Intelligence) system may contain inaccuracies and/or contain errors. Investing in stocks carries inherent risks, and past performance is not indicative of future results. This report does not account for your personal financial circumstances, objectives, or risk tolerance. Always conduct your own research or consult with a qualified financial advisor before making investment decisions. The analysis and recommendations provided are based on historical and current data and may not fully reflect future market conditions or unexpected developments. Neither the creators of this report nor its affiliated entities guarantee the accuracy, completeness, or reliability of the information presented. Use this report at your own discretion and risk.