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Nuwellis, Inc. (NUWE)

Q4 2025 Earnings Call· Tue, Mar 10, 2026

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Transcript

Operator

Operator

Thank you for your continued patience. Your meeting will begin shortly. If you need assistance at any time, please press 0, and a member of our team will be happy to help you. Hello, and welcome, everyone, to Nuwellis, Inc.'s 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. 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

Analyst

Thank you, Operator. And thank you all for joining today's conference call to discuss Nuwellis, Inc.'s 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 L. Erb, Nuwellis, Inc.'s Chairman of the Board and CEO, and our newly appointed CFO, Carissa Schultz. At 8:00 a.m. Eastern Time today, Nuwellis, Inc. released financial results for the fourth quarter and full year 2025. If you have not received Nuwellis, Inc.'s 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. 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-Ks. With that, I would now like to turn the call over to John.

John L. Erb

Analyst

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, Inc. 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. 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 transactions that support 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. Historically, Nuwellis, Inc. has been described as a fluid management company. Over the course of the year, we…

Carissa Schultz

Analyst

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 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 eight units sold compared to three 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 cath utilization, partially offset by lower console sales compared to the third quarter. 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 $400,000 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 contribution following strategic rationalization, and prior-year SeaStar sales prior to that agreement's termination. Heart failure and pediatrics grew 814% year over year, respectively, partially offset by a 19% decline in critical care. Full-year gross margin was 62%, three percentage points higher 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 noncash warrant valuation expense and approximately $300,000 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. As we move into 2026, our financial priorities focus 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

Operator

Thank you. And if you would like to ask a question, please press 1 on your keypad. To leave the queue at any time, press 2. Once again, that is star and 1 to ask a question. And once again, that is star and 1 if you would like to join the queue. We are showing one question comes from the line of Anthony V. Vendetti with Maxim Group. Please go ahead. Your line is open.

Anthony V. Vendetti

Analyst

Thank you. Yeah. So I wanted to, John, just talk about, you know, you said you had some operational changes this year and refocus of the business. Can you talk a little bit about, you know, where the salesforce and where your main focus is now versus where it was maybe a couple years ago? And then also, second part of the question is going to be on the Rendytek—if I am pronouncing it correctly—the acquisition, how those products are going to be incorporated into your current product portfolio.

John L. Erb

Analyst

Thanks. Sure, Anthony. 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 we saw that impact in the second half of the year. We are really beginning to see much greater growth in 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, and that was the primary reason we ended up going to contract manufacturing with KDI Precision Manufacturing. That has really brought stability to our supply and product quality that we are very pleased with. We also looked hard at expenses, looking at our cash burn and how we could reduce it. Internationally, particularly in the European Union, we have lost money, continuing 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 going to be two or three years down the road. So, 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. So a lot of activity around refocusing the business. You know, the…

Anthony V. Vendetti

Analyst

Okay, John. That is helpful. Maybe since it looked like fourth quarter sales were driven more by utilization within existing accounts versus new accounts, so RendiA Tech—is the focus going to be to try to get more utilization out of the current accounts as we begin this year and try to get Rendia Tech into all those accounts? And then where is your salesforce or territory manager number currently, and is that expected to be constant for this year, or do you expect to add as you move through the year?

John L. Erb

Analyst

Thanks. Sure. Well, let me start with the second part of that question. Right now, our total sales team is 24 individuals between account managers and clinical specialists. And that really brings it up to what was budgeted for a 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 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 a really big opportunity for the company. So that is a primary focus. Of course, we will continue to support our heart failure customers and patients and work closely in nephrology in the pediatric area as the product sees. But 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 Rendiatek acquisition as an opportunity to enhance utilization within those accounts.

Anthony V. Vendetti

Analyst

Okay. Thanks so much. That is very helpful. I will jump back in the queue.

Operator

Operator

Thank you. And once again, if you would like to ask a question, please press 1 on your keypad now. We will pause for another moment. And once more, that is star and 1 if you would like to join the queue. Thank you. And at this time, there are no further questions in queue. I will now turn the meeting back to management for closing remarks.

John L. Erb

Analyst

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 Rendiatek 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. 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 RoentDeck and plan to relaunch the Clarity product midyear. We also continue progressing development of Vivien, 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

Operator

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