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Nuwellis, Inc. (NUWE)
:NUWE
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Nuwellis
(NASDAQ:NUWE)
48Neutral
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. S&P 500 (SPY)
Market Cap
$4.11M
Dividend YieldN/A
Average Volume (3M)132.60K
Price to Earnings (P/E)―
Beta (1Y)1.68
Revenue Growth-1.40%
EPS Growth91.79%
CountryUS
Employees38
SectorHealthcare
Sector Strength65
IndustryMedical - Devices
Share Statistics
EPS (TTM)-38.64
Shares Outstanding4,373,986
10 Day Avg. Volume83,755
30 Day Avg. Volume132,605
Financial Highlights & Ratios
PEG RatioN/A
Price to Book (P/B)N/A
Price to Sales (P/S)0.55
Price to Cash Flow (P/CF)-0.50
P/FCF Ratio0.00
Enterprise Value/Market CapN/A
Enterprise Value/RevenueN/A
Enterprise Value/Gross ProfitN/A
Enterprise Value/EbitdaN/A
Forecast
1Y Price Target
$13.00Price Target Upside1254.17% Upside
Rating ConsensusModerate Buy
Number of Analyst Covering1
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 makes money primarily through the sale of its flagship product, the Aquadex FlexFlow System, along with related supplies and accessories. The company targets healthcare providers, including hospitals and clinics, as its primary customers. Revenue is generated from the direct sales of the system, as well as recurring sales of disposable components required for each treatment session. Additionally, Nuwellis may engage in partnerships or collaborations with healthcare institutions to expand its market reach and enhance the adoption of its fluid management solutions. The company's earnings are influenced by factors such as the prevalence of fluid overload conditions, healthcare regulations, and the adoption rate of its technology in the medical community.
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
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.45
Neutral
Balance Sheet
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.50
Neutral
Cash Flow
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.40
Negative
| Breakdown | ||||
| Dec 2024 | Dec 2023 | Dec 2022 | Dec 2021 | Dec 2020 |
|---|---|---|---|---|
| Income Statement | Total Revenue | |||
| 8.74M | 8.86M | 8.54M | 7.92M | 7.44M | Gross Profit |
| 5.68M | 4.98M | 4.75M | 4.49M | 4.06M | EBIT |
| -10.99M | -17.63M | -17.17M | -19.53M | -17.03M | EBITDA |
| -5.24M | -16.36M | -4.90M | -19.06M | -16.65M | Net Income Common Stockholders |
| -10.62M | -20.21M | -14.53M | -19.58M | -15.84M |
| Balance Sheet | Cash, Cash Equivalents and Short-Term Investments | |||
| 5.09M | 3.80M | 18.31M | 24.20M | 14.44M | Total Assets |
| 9.86M | 9.77M | 24.67M | 30.42M | 20.01M | Total Debt |
| 545.00K | 760.00K | 984.00K | 1.18M | 339.00K | Net Debt |
| -4.55M | -3.04M | -16.75M | -23.03M | -14.10M | Total Liabilities |
| 3.33M | 6.56M | 12.32M | 4.47M | 3.69M | Stockholders Equity |
| 6.53M | 3.21M | 12.36M | 25.95M | 16.32M |
| Cash Flow | Free Cash Flow | |||
| -9.65M | -18.18M | -15.27M | -18.10M | -16.87M | Operating Cash Flow |
| -9.59M | -17.94M | -15.15M | -17.88M | -16.57M | Investing Cash Flow |
| -60.00K | 330.00K | 14.73M | -219.00K | -267.00K | Financing Cash Flow |
| 10.96M | 3.68M | 9.42M | 27.87M | 30.02M |
Nuwellis Technical Analysis
Negative
0.96
Price Trends
1.20
Negative
1.25
Negative
1.95
Negative
Market Momentum
-0.07
Positive
31.89
Neutral
19.35
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 0.96 is below the 20-day moving average (MA) of 1.13, below the 50-day MA of 1.20, and below the 200-day MA of 1.95, indicating a bearish trend. The MACD of -0.07 indicates Positive momentum. The RSI at 31.89 is Neutral, neither overbought nor oversold. The STOCH value of 19.35 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 36 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 (48)
Financial Indicators
Name | Overall Rating | Market Cap | P/E Ratio | ROE | Dividend Yield | Revenue Growth | EPS Growth |
|---|---|---|---|---|---|---|---|
78 Outperform | $146.96B | 80.87 | 9.03% | ― | 17.60% | 16.84% | |
76 Outperform | $18.44B | 45.47 | 43.03% | ― | 22.07% | 101.95% | |
73 Outperform | $22.53B | 25.53 | 7.24% | 0.85% | 3.84% | -9.29% | |
70 Outperform | $823.30M | 12.92 | 10.30% | ― | -0.88% | 67.38% | |
53 Neutral | $3.40B | ― | -5.76% | ― | 5.28% | -292.14% | |
48 Neutral | $6.86B | 1.11 | -51.04% | 2.47% | 16.66% | 1.53% | |
48 Neutral | $4.11M | ― | -229.24% | ― | -1.40% | 91.79% |
* Healthcare Sector Average
Performance Comparison
NUWE
Nuwellis
0.96
-12.38
-92.80%
BSX
Boston Scientific
101.24
33.79
50.10%
ICUI
ICU Medical
137.80
35.22
34.33%
PODD
Insulet
263.18
99.13
60.43%
ZBH
Zimmer Biomet Holdings
112.37
-14.97
-11.76%
THRM
Gentherm
26.66
-28.60
-51.76%
Nuwellis Earnings Call Summary
Earnings Call Date: Mar 11, 2025 | % Change Since: -23.81% | Next Earnings Date: May 13, 2025
Earnings Call Sentiment Neutral
The earnings call presented a balanced view with significant achievements such as the increase in consumables utilization, growth in the Critical Care business, and a major improvement in outpatient reimbursement. However, these were counterbalanced by challenges like the overall revenue decline, particularly in the heart failure and pediatrics segments, and the impact of a voluntary recall. The strategic initiatives, including the recent publication of clinical data and cost reductions, indicate positive future prospects.Highlights
Increase in Consumables Utilization
There was a 21% increase in consumables utilization, indicating higher usage and adoption of the Aquadex system by clinicians.
Critical Care Business Growth
The Critical Care business saw a 35% year-over-year quarterly revenue growth, driven by an increase in both console sales and consumables utilization.
Publication of Clinical Data
A recent peer-reviewed publication in JACC: Heart Failure demonstrated a 60% reduction in heart failure events at 30 days for patients treated with Aquadex therapy compared to traditional IV diuretics.
Improvement in Gross Margin
Gross margin improved to 58.4% in Q4 2024 from 54.4% in the prior year quarter, primarily driven by higher manufacturing volumes and lower fixed overhead costs.
Operating Loss Reduction
Operating loss in Q4 2024 was reduced to $2.4 million from $3.6 million in the prior year, showing a $1.2 million improvement.
Significant Increase in Outpatient Reimbursement
Effective January 1, 2025, the facility reimbursement fee for Aquadex increased nearly four times from $413 to $1,639 per day, opening a new market in outpatient services.
Lowlights
Revenue Decline
Nuwellis generated $2.3 million in revenue for Q4 2024, a 9% decrease year-over-year due to declines in U.S. console sales and international sales.
Decline in Heart Failure and Pediatrics Segments
The heart failure and pediatrics customer categories experienced declines of 36% and 20% respectively, attributed to lower console sales.
Voluntary Recall Expense
A voluntary recall of specific lots of blood circuit units resulted in a non-recurring expense of approximately $150,000.
Decrease in R&D Spending
Research and development expenses decreased to $831,000 from $1.4 million in the prior year, primarily due to reduced consulting fees and compensation-related expenses.
Company Guidance
During the Nuwellis earnings conference call for Q4 and full year 2024, the company provided several key metrics and guidance for 2025. Nuwellis reported $2.3 million in revenue for Q4 2024, marking a 9% year-over-year decrease, although consumables utilization increased by 21%. Critical Care revenue grew by 35% year-over-year, despite heart failure and pediatrics seeing declines of 36% and 20%, respectively. Gross margin improved to 58.4% from 54.4% in the previous year, while operating expenses decreased by 25% to $3.7 million, contributing to a reduced operating loss of $2.4 million compared to the prior year's $3.6 million. The company highlighted a new CMS reimbursement increase for outpatient ultrafiltration therapy, effective January 1, 2025, which is expected to drive top-line growth. Additionally, a recent publication in JACC: Heart Failure indicated a 60% reduction in heart failure events for patients using the Aquadex therapy compared to traditional IV diuretics, underscoring the potential for broader adoption of their technology.Nuwellis Corporate Events
Executive/Board Changes
Nuwellis Appoints John Erb as Interim CEO
Neutral
Feb 24, 2025
On February 24, 2025, Nuwellis, Inc. announced the retirement of Nestor Jaramillo, Jr. as President and CEO, effective February 18, 2025. John Erb, the current Chairman of the Board, has been appointed as the Interim President and CEO. Mr. Jaramillo’s departure was amicable, and he will receive certain benefits as per the Separation Agreement. The company plans to engage an executive search firm to find a permanent CEO. Mr. Erb, who has a long history with the company and extensive experience in the medical device industry, will lead Nuwellis during this transitional period.
Glossary
OutperformA stock rated as "Outperform" is expected to perform better than the overall market or a specific benchmark over the near-to-medium term. This rating suggests that the stock is likely to deliver higher returns compared to the average returns of other stocks in the same sector or market index. Investors might consider this stock a good buying opportunity.
NeutralA stock rated as "Neutral" is expected to perform in line with the overall market or a specific benchmark. This rating indicates that the stock is neither particularly attractive nor unattractive for investment. Investors may consider holding onto the stock, as it is not expected to either significantly outperform or underperform the market.
UnderperformA stock rated as "Underperform" is expected to perform worse than the overall market or a specific benchmark over the near-to-medium term. This rating suggests that the stock may deliver lower returns compared to the average returns of other stocks in the same sector or market index. Investors might consider selling the stock or avoiding it as an investment.
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.