Nuwellis, Inc. Q1 FY2026 Earnings Call

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. Thank you for your continued patience. Please stand by. Your program is about to begin. Good morning, and welcome to Nuwellis' Earnings Conference Call for the first quarter ended 03/31/2026. All participants will be in a listen-only mode. Should you need assistance after today's presentation, there will be an opportunity to ask questions. To withdraw your question, participants on this call are advised that the audio of this conference call is being broadcast live over the Internet and is also being recorded for playback purposes. A replay of this call will be available approximately one hour after the end of the call. 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 first quarter ended 03/31/2026. In addition to myself, with us today are John L. Erb, Nuwellis' Chairman of the Board, and our CFO, Carisa Schultz. At 8:00 AM Eastern time today, Nuwellis released financial results for the first quarter of 2026. If you have not received Nuwellis' earnings release, please visit the Investors 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 currently 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.

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 calls, 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. 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, 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 continue 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 operations as we continue executing against our strategy. In addition, we strengthened the board with the appointment of Martin Emerson and the reappointment of David 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 three 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 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 first quarter 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 fourth quarter 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 critically 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 physician-directed precision fluid removal in a high-acuity patient population. Importantly, our future pediatric innovation is being built into a category where 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 Vivien, 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 first quarter demonstrates meaningful progress against the strategy we outlined coming into 2026. We have 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 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 first quarter financial performance and balance sheet position. Revenue for Q1 2026 was $2.4 million compared with $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 were placed with pediatric accounts and new consoles were placed with adult accounts. Circuit sales also increased 15% reflecting continued growth in the number of patients treated with Aquadex therapy. Gross margin for Q1 2026 was 70.1%, a 14 percentage point 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 Q1 2026 were approximately $6.0 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 Q1 2026 was approximately $4.3 million. As of 03/31/2026, 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 enhanced 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. To leave the queue at any time, press 2. Once again, that is *1 to ask a question. We will take our first question from Nicholas Sherwood with Maxim Group. Please go ahead. Your line is open.

My first question is looking at the new commercial coverage with the South Texas territory. Can you talk about how your sales team is building out relationships in that territory? And outside of that territory, what other regions are you targeting for expansion?

Sure. We are excited about that new territory primarily because we 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 split a larger territory covering Oklahoma, kept the rep that had built the northern part of Texas, and allowed Libby, who operates out of Houston, to take the southern part. So it is really positive from the standpoint that it was not just a new territory; it was bringing back a very experienced sales leader. Beyond that, our growth area in the Northeast has consistently been the highest. If we look at New York and the Washington-Philadelphia area, where we have added some new large pediatric accounts like Children's Hospital of Philadelphia, it has been a focus and an important growth area for us. So 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, particularly in pediatrics in the Seattle area where Seattle Children's is a large account for us. Those are our focused areas.

I really appreciate that detail. Can you give any more details you have on the integration with RendiaTech and how you have been able to present some of those offerings to your current customer base?

Actually, we have not yet introduced RendiaTech to the U.S. market. RendiaTech had two products: one they had marketed before they went bankrupt, both internationally and outside the U.S., which was a urine collection device used in critical care; and the other was a product in development that moved from a critical care urine collection to actually monitoring kidney output. That monitoring product was really the target product that we saw great value in acquiring RendiaTech for. We have just completed that acquisition, brought the inventory they had back into the U.S. from Israel — it was an Israeli company — and we are now in development on that more valuable product. That product will not only be important in critical care because measuring fluids in and fluids out is essential, it complements Aquadex. One thing we do with Aquadex is obviously take fluid out, but clinicians also measure urine output. They take urine samples, send them to the lab, and get a lab report back that identifies kidney health and provides electrolytes like sodium, potassium, calcium, and others. What the new product we will be developing from RendiaTech does is provide immediate bedside readings of those analytes or electrolyte balances in the urine. So it will be highly differentiated from anything on the market today, and we plan to introduce that product to the U.S. market in 2027.

Okay. And how many Aquadex units were you able to sell in the first quarter?

Fifteen.

Okay. All right. Well, those are all my questions, and thank you for providing all that detail. I will return to the queue.

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

Thank you. We are encouraged by the progress made in the first quarter and remain focused on 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, and 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.