Nuwellis Q4 2025 Earnings Report

Nuwellis EPS Results

• Actual EPS: -$1.50
• Consensus EPS: -$1.56
• Beat/Miss: Beat by +$0.06
• One Year Ago EPS: N/A

Nuwellis Revenue Results

• Actual Revenue: $2.42 million
• Expected Revenue: $2.31 million
• Beat/Miss: Beat by +$114.00 thousand
• YoY Revenue Growth: N/A

Nuwellis Announcement Details

• Quarter: Q4 2025
• Date: 3/10/2026
• Time: Before Market Opens
• Conference Call Date: Tuesday, March 10, 2026
• Conference Call Time: 9:00AM ET

Nuwellis (NASDAQ:NUWE) (NASDAQ:NUWE) is a medical technology company focused on developing therapies and devices to manage fluid overload in patients with cardiorenal and cardiovascular conditions. The company’s core business revolves around designing, manufacturing and marketing the Aquadex™ FlexFlow® System, a gentle ultrafiltration device intended to remove excess fluid in patients with acute decompensated heart failure, cardiorenal syndrome and other fluid‐overload disorders. By providing an alternative to traditional diuretic therapy, Nuwellis aims to improve patient outcomes and reduce hospital stays.

The Aquadex FlexFlow System operates by drawing blood through a low‐shear filter and returning it to the patient, allowing precise control of fluid removal at the bedside outside of an intensive care setting. This technology is used in hospitals, specialty renal centers and other acute care facilities. The system’s design emphasizes ease of use for clinicians, with automated control features and real‐time monitoring that support individualized treatment plans and help mitigate the risks associated with rapid fluid shifts.

Originally founded as Renal Solutions in 2005, the company adopted the Nuwellis name in 2016 to reflect a broader commitment to advancing fluid management therapies. Headquartered in Plymouth, Minnesota, Nuwellis holds both FDA clearance in the United States and CE Mark approval for distribution across Europe. Its sales and distribution network serves acute care hospitals and renal clinics across North America and select international markets.

Nuwellis continues to invest in research and development aimed at expanding the clinical applications of its ultrafiltration technology. The company’s leadership team includes seasoned executives with extensive experience in medical devices and healthcare innovation. Ongoing efforts focus on regulatory approvals, commercial partnerships and clinical studies to validate new indications and broaden access to its therapies worldwide.

Nuwellis Q4 2025 Earnings Call Transcript

Key Takeaways

• Positive Sentiment: Company completed a transition to contract manufacturing with KDI Precision Manufacturing to improve supply reliability and long-term structural margins, prioritizing operational predictability over short-term cost cuts.
• Positive Sentiment: Strategic refocus on the cardiorenal continuum—with emphasis on heart failure and pediatrics—was reinforced by expanded IP and a NIH grant supporting the pediatric device (Vivian), strengthening long-term differentiation.
• Positive Sentiment: Management is integrating the Rendiatech acquisition (Clarity) to add bedside urine-output and analyte monitoring for ICU/critical-care patients, with a planned mid-year relaunch to drive deeper utilization in existing accounts.
• Negative Sentiment: Financials show mixed trends: Q4 revenue rose to $2.4M and gross margin improved, but full-year revenue fell 5%, net loss was $17.5M (including a $6.4M non-cash warrant expense), and year-end cash was only about $1.2M after ~$10.9M cash usage.
• Neutral Sentiment: Commercially, U.S. console sales jumped 208% in Q4 and the direct sales team is now 24 people focused on driving utilization in existing accounts (particularly critical care), with headcount expected to remain stable in 2026.

Presentation

[Operator]

Hello and welcome everyone joining today's Nuwellis fourth quarter 2025 earnings conference call. At this time, all participants are in a listen-only mode. Later, you will have the opportunity to ask questions during the question and answer session. To register to ask a question at any time, please press star one on your telephone keypad. Please note this call is being recorded. We are standing by if you should need any assistance. It is now my pleasure to turn the meeting over to Leah McMullen, Director of Communications. Please go ahead.

[Leah McMullen, Senior Director of Marketing & Communications at Nuwellis]

Thank you, operator, and thank you all for joining today's conference call to discuss Nuwellis' corporate developments and financial results for the fourth quarter and full year as of December 31, 2025. In addition to myself, with us today are John Erb, Nuwellis' Chairman of the Board and CEO, and our newly appointed CFO, Carisa Schultz. At 8:00 A.M. Eastern Time today, Nuwellis released financial results for the fourth quarter and full year 2025. If you have not received Nuwellis' earnings, please visit the investor page on the company's website. During the conference call, the company will be making forward-looking statements. All forward-looking statements made during today's call will be protected under the Private Securities Litigation Reform Act of 1995. Any statements that relate to expectations or predictions of future events and market trends, as well as our estimated results or performance, are forward-looking statements.

[Leah McMullen, Senior Director of Marketing & Communications at Nuwellis]

All forward-looking statements are based upon our current estimates and various assumptions. These statements involve material risks and uncertainties that could cause actual results or events to materially differ from those anticipated or implied by these forward-looking statements. All forward-looking statements are based upon current available information, and the company assumes no obligation to update these statements. Accordingly, you should not place undue reliance on these statements. Please refer to the cautionary statements and discussion of risk in the company's filings with the Securities and Exchange Commission, including the latest 10-K. With that, I would now like to turn the call over to John.

[John Erb, Chairman of the Board at Nuwellis]

Thank you, Leah, and good morning, everyone. I would like to begin by stepping back from the quarter and reflecting on the year as a whole. 2025 was not a continuation year for Nuwellis. It was a year of structural change and deliberate repositioning. While full-year revenue declined 5% compared to 2024, the defining characteristic of 2025 was not top-line variability. It was the strengthening of the company's operating foundation and the clarification of our long-term strategy. Throughout the year, we made intentional decisions to simplify the business, improve operational discipline, and concentrate resources in areas where clinical adoption and economic value are most aligned. A central initiative was the transition of manufacturing to KDI Precision Manufacturing. This was a significant operational undertaking requiring coordination across supply chain, quality systems, and production leadership. The objective was not short-term cost reduction.

[John Erb, Chairman of the Board at Nuwellis]

It was long-term reliability, scalable manufacturing alignment, and improved structural margin performance. As we move forward, this transition enhances operational predictability and strengthens our supply chain foundation. We also evaluated and refined our international commercial strategy. Portions of that business generated inconsistent returns and required disproportionate resources. During the year, we reduced exposure in certain markets and redirected focus towards geographies where clinical demand and commercial conversion are more predictable. That decision reflects discipline and prioritization. Over the course of the year, we also maintained access to capital through financing transitions that supported operational continuity during a period of transition. We ended the year with approximately $1.2 million in cash and no outstanding debt. Liquidity management and disciplined capital allocation remain central priorities as we execute our strategy. Beyond operational and financial refinements, 2025 marked a critical clarification of strategic positioning.

[John Erb, Chairman of the Board at Nuwellis]

Historically, Nuwellis has been described as a fluid management company. Over the course of the year, we sharpened our focus around the cardiorenal continuum. Our technology serves patients whose cardiac and renal conditions are tightly interrelated and where precision volume management directly influences outcomes across both organ systems. This alignment reflects where we see the strongest clinical traction and the most durable long-term opportunity. Growth in heart failure and pediatrics reinforces that our value proposition is most compelling within complex cardiorenal populations. Within this strategy, our pediatric program represents a meaningful extension of our platform. During the year, we expanded intellectual property supporting our pediatric device development and were the beneficiary of a National Institutes of Health grant to advance this program.

[John Erb, Chairman of the Board at Nuwellis]

The combination of strengthened IP effect and non-dilutive NIH funding provides external validation of the clinical importance of this work and reinforces the long-term defensibility of our innovation within the cardiorenal continuum. Turning to the fourth quarter, revenue was $2.4 million, an increase of 4% compared to the prior year quarter and 9% sequentially. US console sales increased 208%, reflecting stronger activity within targeted accounts. Gross margin expanded to 68.2% in the quarter, compared to 58.4% in the prior year period. Full year operating expenses were $400,000 lower than the prior year, reflecting tighter expense management, improved forecasting discipline and more selective commercial deployment. These results reinforce a core operating principle where clinical adoption is established, utilization expands. Our strategy is not broad-based expansion across all possible customer opportunities.

[John Erb, Chairman of the Board at Nuwellis]

It is disciplined concentration in accounts and patient populations where clinical pull and economic value are demonstrable. Taken together, 2025 was a year of operational strengthening, portfolio alignment, disciplined capital management and strategic clarity. The organization enters 2026 more focused, more disciplined, and structurally stronger than it was a year ago. As we begin 2026, we are further strengthened our financial leadership. Earlier this year, we welcomed Carisa Schultz as Chief Financial Officer. Carisa brings deep experience in medical technology, finance and operational leadership. Her focus on forecasting precision, capital allocation discipline and financial transparency supports the operating model we have refined over the past year. With that, I will turn the call over to Carisa for a detailed review of our financial results.

[Carisa Schultz, Retired CFO at Nuwellis]

Thank you, John, and good morning. I will begin with fourth quarter performance before turning to full year results and our balance sheet position. Revenue for the fourth quarter of 2025 was $2.4 million, representing a 4% increase compared to the prior year quarter and a 9% increase sequentially. The year-over-year improvement was driven by a 208% increase in U.S. console sales, with 8 units sold compared to 3 in the prior year period, and an 11% circuit average selling price increase. International sales increased 59% year-over-year, largely as a result of last time buys from distributors whose territories we were exiting. These gains were partially offset by a 24% decline in critical care revenue. Sequentially, revenue growth was driven primarily by increased catheter utilization, partially offset by lower console sales compared to the third quarter.

[Carisa Schultz, Retired CFO at Nuwellis]

Gross margin for the fourth quarter was 68.2%, an improvement of 9.9 percentage points compared to the prior year quarter. Operating expenses for the quarter were $4.1 million, representing a $0.4 million increase compared to the prior year quarter. The year-over-year increase reflects higher professional services, recruiting activity and targeted development initiatives. Operating loss for the fourth quarter was $2.4 million, flat with the prior year quarter. Net loss attributable to common shareholders for the quarter was $2.4 million. Turning to full year results, revenue for 2025 was $8.3 million, a 5% decrease compared to the prior year. The year-over-year decline reflects lower consumables utilization, lower U.S. console average selling prices, reduced international contributions following strategic rationalization and prior year SeaStar sales prior to that agreement's termination.

[Carisa Schultz, Retired CFO at Nuwellis]

Heart failure and pediatrics grew 8% and 14% year-over-year, respectively, partially offset by a 19% decline in critical care. Full year gross margin was 62%, 3 percentage points than the prior year. Operating expenses for the full year were $16.2 million, slightly lower than the prior year, reflecting improved expense discipline and forecasting rigor. Net loss attributable to common shareholders for the full year was $17.5 million, which includes a $6.4 million non-cash warrant valuation expense and approximately $0.3 million in executive severance expense. From a liquidity standpoint, full year cash utilization was approximately $10.9 million. We ended the year with approximately $1.2 million in cash and no outstanding debt. During 2025, we raised approximately $7 million in net proceeds through financing activities, supporting operations during a period of structural transition.

[Carisa Schultz, Retired CFO at Nuwellis]

As we move into 2026, our financial priorities remain focused on gross margin consistency, disciplined expense management, enhanced visibility into commercial conversion, and prudent capital deployment. This concludes our prepared remarks. Operator, we would now like to open the call to questions.

[Operator]

Thank you. If you would like to ask a question, please press star one on your keypad. To leave the queue at any time, press star two. Once again, that is star, then one to ask a question. We will pause for just a moment to allow everyone a chance to join the queue. Once again, that is star, then one if you would like to join the queue. We are showing one question comes from the line of Anthony Vendetti with Maxim Group. Please go ahead. Your line is open.

[Anthony Vendetti, Executive Managing Director of Research at Maxim Group]

Thank you. Yeah, I wanted to, John, just talk about you said you had some operational changes this year and a refocus of the business. Can you talk a little bit about where the sales force and where your main focus is now versus where it was maybe a couple years ago? Second part of the question is gonna be on the Rendiatech, if I'm pronouncing it correct, the acquisition, how those products are gonna be incorporated into your current product portfolio. Thanks.

[John Erb, Chairman of the Board at Nuwellis]

Sure, Anthony. Good morning. Well, let me start off and say that in 2025 we reinforced our direct sales team. We had declined at the beginning of the year by several account territories, and we brought some folks on board, both account managers and clinical specialists, to bring us back up to the budgeted amount. Which really we saw that impact in the second half of the year and really beginning to see much greater growth in the beginning of 2026. You know, at the beginning of the year, this year, we were recovering from a product recall and from some quality issues that we really needed to redirect the business. That was the primary reason we ended up going to contract manufacturing with KDI Precision Manufacturing.

[John Erb, Chairman of the Board at Nuwellis]

That's really brought stability to our supply and product quality that we're very pleased with. We also looked hard at expenses, looking at our cash burn and how could we reduce it. Internationally, particularly in the European Union, we have lost money continually year after year. We made the decision that we would exit the EU and basically successfully pulled out of that and reduced our cash burn. We also looked hard at an expensive clinical trial that was in place with the REVERSE-HF clinical trial. It was budgeted to spend an additional $3 million to complete the trial, take a couple of years, and the benefit of a very successful trial was still gonna be two or three years down the road.

[John Erb, Chairman of the Board at Nuwellis]

Again, looking at cash management, we made the decision to terminate that trial. We are actively now working with the principal investigators with the data that was completed, to put together a publication with some positive results. A lot of activity around refocusing the business. You know, the NIH grant that we received for pediatrics, development of the renal replacement therapy device is, very positive for us, and we continue to grow in the pediatrics area. I'd say that a bit of a refocus, not so much away from heart failure, but in addition to heart failure, really focusing on the pediatric nephrologists and the benefit that the Aquadex product was bringing to the pediatric marketplace. Let's see, what else? That, I think that covered your main question.

[John Erb, Chairman of the Board at Nuwellis]

The second part of your question regarding Rendiatech, the value there is in critical care. You know, as we remove fluid after a patient has come off of the heart-lung machine, very gently and very carefully, which is what the heart needs, what the kidneys need after extubation from the heart-lung machine. They also measure all the fluid off, and renal output or urine output is another critical measure. What Rendiatech has is a technology basically that helps measure that renal or urine output, in the ICU. What's exciting about that product is the opportunity that we're already working on is to enhance the capability of not just measuring flow and measuring quantity, but also measuring the analytes or electrolytes that are in the urine. That is a key biomarker for kidney health, acute kidney injury.

[John Erb, Chairman of the Board at Nuwellis]

About 60% of patients in critical care that come off of the heart-lung machine do experience acute kidney injury. Rather than that urine being sent to the lab and waiting for lab results to come back to look at the potassium, sodium, oxygen level in the urine, they can get this bedside. That was really the primary reason we were interested in the Rendiatech acquisition, is that very differentiated capability that it will bring to the ICU.

[Anthony Vendetti, Executive Managing Director of Research at Maxim Group]

Okay, John, that's helpful. Maybe since it looked like fourth quarter sales was driven more by utilization within existing accounts versus new accounts. Rendiatech is the focus gonna be to try to get more utilization out of the current accounts as we begin this year, and try to get Rendiatech into all those accounts? Then where is your sales force or territory manager number currently? Is that expected to be constant for this year, or do you expect to add as you move through the year? Thanks.

[John Erb, Chairman of the Board at Nuwellis]

Sure. Well, let me start with the second part of that question, and right now our total sales team is 24 individuals between account managers and clinical specialists. That really brings it up to what was budgeted for headcount in 2025, and I anticipate keeping it at that number through 2026. We have a lot of opportunity in existing accounts and this is the first part of your question. We will focus on improved or increased utilization. The sales team is primarily focused on critical care. We see critical care, ICU, the cardiorenal issue in these patients that have gone through cardiac surgery as really a big opportunity for the company. That's a primary focus.

[John Erb, Chairman of the Board at Nuwellis]

Of course, we will continue to support our heart failure customers and patients and working closely in nephrology in the pediatric area as a product use. I would say that the majority of the focus is to grow the critical care business in existing accounts. A lot of these accounts are already heart failure accounts that we are expanding into critical care, and we see the Rendiatech acquisition as an opportunity to enhance utilization within those accounts.

[Anthony Vendetti, Executive Managing Director of Research at Maxim Group]

Okay. Thanks so much. That's very helpful. I'll jump back in the queue.

[Operator]

Thank you. Once again, if you would like to ask a question, please press star one on your keypad now. We'll pause for another moment. Once more, that is star and one if you would like to join the queue. Thank you. At this time, there are no further questions in queue. I will now turn the meeting back to management for closing remarks.

[John Erb, Chairman of the Board at Nuwellis]

Thank you. 2025 marked a necessary inflection point for the company. We made decisive adjustments to strengthen the operating model and clarify our strategic focus. As we enter 2026, we are doing so with renewed momentum, including the execution of our agreement to acquire Rendiatech and the planned expansion of our portfolio, the appointment of Ms. Schultz as our Chief Financial Officer, and additional capital to support operations. Entering this next phase, we are more disciplined, more deliberate, and aligned around the cardiorenal opportunity that will define our next phase of growth. The structural work completed in 2025 positions us to shift from refinement to execution in 2026. Our objective in 2026 is to translate strategic clarity into more predictable commercial performance.

[John Erb, Chairman of the Board at Nuwellis]

We will continue executing with discipline, concentrating resources in cardiorenal populations where clinical adoption and utilization are strongest and driving deeper penetration within active accounts. We are actively integrating our recent acquisition of Rendiatech and plan to relaunch the Clarity product mid-year. We also continue progressing development of Vivian, our novel pediatric solution supported by the NIH grant funding. We will maintain financial rigor, strengthen margin consistency, and prioritize capital efficiency as we scale. We appreciate the continued support of our shareholders, the drive and focus of our team, and look forward to updating you on progress throughout the year. Thank you and goodbye.

[Operator]

Thank you. This brings us to the end of today's meeting. We appreciate your time and participation. You may now disconnect.

Participants

Executives

• Carisa Schultz, Retired CFO
• John Erb, Chairman of the Board
• Leah McMullen, Senior Director of Marketing & Communications

Analysts

• Anthony Vendetti, Executive Managing Director of Research at Maxim Group