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I would now like to turn the conference over to Leah McMullen, Director of Communications. Please go ahead.

Thank you, operator. Thank you for joining today's conference call to discuss Nuwellis' corporate developments and financial results for the Q1 ended March 31, 2026. In addition to myself, with us today are John Erb, Nuwellis' Chairman of the Board and CEO, and our CFO, John Erb. At 8:00 A.M. Eastern Time today, Nuwellis released financial results for the Q1, 2026. If you have not received Nuwellis' earnings release, please visit the investor's page on the company's website. During this 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 any 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.

Thank you, Leah, and good morning, everyone. I would like to begin by framing the quarter in the context of the work we completed over the past year. As we discussed on our last call, 2025 was a year of structural change and deliberate repositioning for Nuwellis. We made important decisions to simplify the business, improve operational discipline, concentrate resources, and clarify our long-term strategy around the cardiorenal care continuum. The Q1 of 2026 represents the next step in that progression. Q1 was the quarter Nuwellis began moving from strategic reset to strategic execution. During the quarter, we strengthened our leadership and capital foundation, delivered stronger financial results, and completed a meaningful strategic acquisition, and continued to validate pediatrics as a key growth category for the company. The important point is that these are not separate events.

Together, they reflect a company moving with greater focus and discipline around the clinical and commercial opportunities where we believe Nuwellis can create the greatest value. First, we continued to strengthen the foundation for execution. During the quarter, we appointed Carisa Schultz as Chief Financial Officer. Carisa brings deep public company healthcare finance experience, and her leadership is already supporting greater rigor around forecasting, capital allocation, and financial visibility. We also completed approximately a $5 million private placement and warrant inducement transaction, adding capital to support our operation as we continue executing against our strategy. We strengthened the board with the appointment of Martin Emerson and the reappointment of David A. McDonald. Their experience in medical technology, commercial scaling, and capital markets adds important perspective as we move into the next phase.

We also sharpened our market coverage and field leadership, including expansion into a new South Texas territory and the return of 3 highly experienced sales leaders. These additions bring deep Aquadex knowledge, established customer relationships, and field experience that will support utilization growth in high-priority accounts. These actions strengthen the leadership, governance, and position the company for more consistent execution across our highest priority growth areas. Second, we saw the stronger foundation begin to show up in our financial performance. Revenue for the Q1 increased 26% year-over-year, supported by a significant increase in console sales and continued growth in circuit sales. Gross margin improved to 70.1%, reflecting the benefits of improved pricing, product mix, and our transition to contract manufacturing at KDI. For us, the meaning behind this result is important.

They demonstrate that the operating work we have been doing is beginning to translate into measurable commercial progress. We are seeing stronger execution, improved economics, and continued increases in the number of patients treated with Aquadex therapy. At the same time, we are continuing to take action to improve operating efficiency and extend our financial runway. We are developing a cash burn reduction plan designed to reduce monthly cash burn by approximately 50% by the Q4 of this year, while keeping resources aligned behind the areas of the business with the strongest commercial traction and strategic value. While we remain focused on disciplined capital allocation and careful expense management, Q1 results reinforce that our strategy is gaining traction where clinical adoption and utilization is strongest. Third, Q1 marked a meaningful step forward in our broader cardiorenal platform strategy.

In March, we completed the acquisition of Rendiatech, adding automated kidney function monitoring capabilities to our product development portfolio. This is an important strategic expansion because it complements our existing focus on precision fluid removal. Aquadex helps clinicians remove excess fluid with precision. Rendiatech's technology adds potential for earlier insight into kidney function and fluid balance changes. Together, they support a broader vision of helping clinicians identify risk earlier, intervene more precisely, and manage complex cardiorenal patients with better information. We also appointed Dr. Stuart Goldstein as Director of Clinical Strategy. Dr. Goldstein is internationally recognized as an adult critical care nephrologist and a pioneer in pediatric nephrology with work that has helped define the modern understanding of acute kidney injury, fluid overload, and continuous renal replacement therapy in critical ill patients.

This expertise strengthens our clinical roadmap across pediatric and adult critical care, where fluid overload, kidney function, and timing of intervention are deeply connected. Finally, pediatrics continues to validate itself as one of the clearest growth strategies for Nuwellis. Pediatrics now represents approximately 50% of total U.S. revenue, and our pediatric footprint expanded to 47 centers nationwide, including six of the top children's hospitals as ranked by U.S. News & World Report. This growth reflects increasing Aquadex utilization in leading pediatric centers and reinforces the clinical relevance of precision fluid removal in a high acuity patient population. Importantly, our future pediatric innovation is being built into a category. We already have meaningful adoption, established relationships, and clinical credibility. During the quarter, we announced the issuance of a new U.S. patent supporting advanced safety design for pediatric extracorporeal therapy.

This patent strengthens the intellectual property foundation behind Vivian, our pediatric CRRT system in development, and supports our longer-term strategy to expand within a category where Nuwellis has already demonstrated market need. Pediatrics is both a commercial growth area today and a long-term strategic opportunity for the company. It gives Nuwellis a clear area of differentiation, a strong clinical foothold, and a focused path for future innovation. Taken together, the Q1 demonstrates meaningful progress against the strategy we outlined coming into 2026. We strengthened the company's leadership, board of directors, and capital foundation. We delivered stronger financial performance. We completed the Rendiatech acquisition and expanded our cardiorenal platform, and we continue to build on a pediatric momentum both commercially and through future innovation.

We are still early in this execution phase, and there is more work ahead, but we believe Q1 reflects a more focused, more disciplined, and more strategically aligned Nuwellis. With that, I will turn the call over to Carisa for a detailed review of our financial results.

Thank you, John, and good morning. I will review our Q1 financial performance and balance sheet position. Revenue for the Q1 of 2026 was $2.4 million compared to $1.9 million in the prior year quarter, representing a 26% increase year-over-year. The increase in sales was driven by stronger console and circuit performance. During the quarter, the company sold 15 consoles, including upgrades from the former FlexFlow to the current SmartFlow systems, new consoles placed with pediatric accounts, and new consoles placed with adult accounts. Circuit sales also increased 15%, reflecting continued growth in the number of patients treated with Aquadex therapy. Gross margin for the Q1 of 2026 was 70.1%, a 14% increase compared to the prior year quarter.

The gross margin improvement reflects improved pricing, product mix, and the transition to contract manufacturing. Operating expenses for the Q1 of 2026 were approximately $6 million, compared to approximately $4.1 million in the prior year quarter. The increase was driven by higher sales headcount and compensation associated with increased sales activity. Net loss attributable to common shareholders for the Q1 of 2026 was approximately $4.3 million. As of March 31st, 2026, the company had no debt and cash and restricted cash equivalents of approximately $2.2 million. As we move forward, our financial priorities remain focused on disciplined capital deployment, gross margin consistency, commercial execution, and enhance visibility into the drivers of utilization and account growth. That concludes my prepared remarks, and I would like to turn the call back over to John for any remaining comments.

Thank you, Carisa. Before opening the call to questions, I want to reinforce the central message for the quarter. Q1 was an important step in translating the work of 2025 into 2026 execution. We are operating with a clearer strategy, a stronger leadership and governance foundation, improved commercial focus, and a broader view of the cardiorenal opportunity ahead of us. Aquadex remains the foundation of the company. Our strategy is to grow from that foundation by deepening utilization in high-need customer categories, expanding our clinical relevance in pediatrics and critical care, and building a broader platform around the management of complex cardiorenal patients. We appreciate the continued support of our shareholders, the focus of our team, and the commitment of the clinicians and institutions using our technologies to support patients with fluid overload. Operator, we would now like to open the call to questions.

Thank you. If you'd like to ask a question, press star one on your keypad. To leave the queue at any time, press star two. Once again, that is star and one to ask a question. We'll take our first question from Nicholas Sherwood with Maxim Group. Please go ahead. Your line is open.

Hi. Thank you for taking my questions. You know, my first question is looking at the new, you know, commercial coverage with the South Texas territory. Can you kinda talk about how, you know, your sales team is building out relationships in that territory and, you know, outside of that territory, you know, what other regions are you kinda targeting for expansion?

Sure. Well, we're excited about that new territory primarily because we have had a former top sales rep rejoin the company. Libby is the rep. She built the New York territory to be one of our largest territories. She and her family moved south a while ago, left the company, went to another company and saw what we were building at Nuwellis and wanted to come back, which of course, we accepted with open arms. In doing that, we had a rep in the larger Texas-Oklahoma area that we were able to split the territory, keep the rep that had built the northern part of Texas and allowed Libby, who operates out of Houston, take the southern part. It really positive from the standpoint that it wasn't just a new territory, it was bringing back a very experienced sales territory.

Beyond that, you know, I think our growth area in the Northeast has consistently been the highest. If we look at New York and the Washington, Philadelphia area, where we've added some new large pediatric accounts like Children's Hospital of Philadelphia, it's been a focus and an important growth area for us. The Northeast continues to be the strongest area. Also, last year, we opened the Western territory with a new sales rep that has gotten off to a really good start, again, particularly in pediatrics in the Seattle area where Seattle Children's is a large account for us. Those are kind of our focused areas.

Okay, perfect. I really appreciate that detail. Can you kinda just give me any more details you have on the integration with Rendiatech and, you know, how you've been able to present, you know, some of those offerings to your current customer base?

Actually have not introduced Rendiatech to the U.S. market yet. Rendiatech had 2 products. One, which they have marketed, before they went bankrupt, in the U.S. and internationally, that was a urine collection, used in critical care. They had a product in development that took just from the critical care urine collection to actually monitoring kidney output. That was really the target product that we saw great value in acquiring Rendiatech. We have just completed that acquisition, brought the inventory that they had back into the U.S. from Israel. It was an Israel company. We are now in development on developing that more valuable product that was really the target of the acquisition. That will not only in critical care, it's really important that they measure fluids in and fluids out.

One thing we do with Aquadex is obviously take fluid out, they're also measuring urine output. They take urine sample, send it to the lab, get a lab report back that gives them identifies the health of the kidney, tells them what oxygen levels, calcium levels, potassium levels, things like that. What this new product that we will be developing from Rendiatech does that at the bedside, they get an immediate reading of those analytes or electrolyte balances in the urine. It's gonna be highly differentiated from anything that's on the market today, we will introduce that product to the U.S. market in 2027.

Okay. How many Aquadex units were you able to sell in the Q1?

15.

Okay. All right. Well, those are all my questions. Thank you for providing all that detail. I'll return to the queue.

Thank you. We have no further questions in the queue at this time. I'll turn the program back to John for some closing remarks.

Thank you. We are encouraged by the progress made in the Q1 and remain focused on the disciplined execution throughout 2026. Our priorities are clear. We will continue supporting Aquadex utilization in the areas where clinical adoption is strongest, advancing the integration of Rendiatech, strengthening our pediatric strategy, and maintaining financial discipline as we build the company. We believe Nuwellis is better positioned today than it was a year ago. We look forward to updating you on our progress in the quarters ahead. Thank you again for joining us today. Goodbye.

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

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.

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.

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 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. The combination of strengthened IP protection and nondilutive 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. U.S. 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 select 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. 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 have further strengthened our financial leadership. Earlier this year, we welcomed Carissa Schultz as Chief Financial Officer. Carissa 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 Carissa for a detailed review of our results.

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.

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.

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.

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 NIH grant that we received for pediatrics development of the renal replacement therapy devices is very positive for us. And we continue to grow in the pediatrics area. So I would say a bit of a refocus, not so much away from heart failure, but in addition to heart failure, really focusing on the pediatric nephrologist and the benefit that the Aquadex product was bringing to the pediatric marketplace. Let me see what else. I think that covered your main question. The second part of your question regarding Aurinia Tech, 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, you know, 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 Rendiatek has is a technology basically that helps measure that renal or urine output in the ICU. What is exciting about that product is the opportunity that we are already working on 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. 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. So that was really the primary reason we were interested in the Rendiatek acquisition, that very differentiated capability that it will bring to the ICU.

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?

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.

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

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.

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.

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