Nuwellis (NASDAQ:NUWE) reported first-quarter financial results on Tuesday. The transcript from the company's first-quarter earnings call has been provided below.

This transcript is brought to you by Benzinga APIs. For real-time access to our entire catalog, please visit https://www.benzinga.com/apis/ for a consultation.

Access the full call at https://viavid.webcasts.com/starthere.jsp?ei=1762535&tp_key=ec351c3e95

Summary

Nuwellis reported a 26% year-over-year revenue increase for Q1 2026, driven by stronger console and circuit sales.

Gross margin improved to 70.1% due to better pricing, product mix, and transition to contract manufacturing.

The company completed a $5 million private placement to bolster its capital base and appointed Carissa Schultz as CFO.

Nuwellis expanded its cardiorenal platform by acquiring Rendiatek, enhancing its kidney function monitoring capabilities.

Pediatric care remains a key growth area, now accounting for 50% of U.S. revenue, with expansion into 47 centers nationwide.

Full Transcript

Leah McMillan (Director of Communications)

Thank you Operator. Thank you for joining today's conference call to discuss Nuwellis's corporate developments and financial Results for the first quarter ended March 31, 2026. In addition to myself, with us today are John Erb Newells, Chairman of the Board and CEO and our CFO Carissa Schultz. At 8:00am Eastern Time today, Newellis released financial results for the first quarter 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 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 10K. With that, I would now like to turn the call over to John.

John Erb Newells

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 first quarter of 2026 represents the next step in that progression. Q1 was the quarter Nuelis 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 Noelis can create the greatest value. First, we continue to strengthen the foundation for execution. During the quarter we appointed Carissa Schultz as Chief Financial Officer. Carissa 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 operation 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 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 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 results is important. They demonstrate that the operating weight, 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. 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 Rendiatac, 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. Randiatex 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 and 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 US Patent supporting advanced safety design for pediatric extracurricular. 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 newellis 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 strengthened the company's leadership, board of directors and capital foundation. We delivered stronger financial performance. We completed the Rendiatek 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 newellis. With that, I will turn the call over to Carissa for a detailed review of our financial results.

Carissa Schultz (Chief Financial Officer)

Thank you John and good morning. I will review our first quarter financial performance and balance sheet. Position revenue for the first quarter 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 Flex Flow 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. Gross margin for the first quarter 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 first quarter 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 first quarter of 2026 was approximately 4.3 million. As of March 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.

John Erb Newells

Thank you. Karissa. 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.

OPERATOR

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.

Nicholas Sherwood (Equity Analyst)

Hi. Thank you for taking my questions. My first question is looking at the new commercial coverage with the South Texas territory. Can you kind of 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?

John Erb Newells

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 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 back, which of course, we accepted with open arms. So 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. So 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, I think our growth area in the Northeast has consistently been the highest. If we look at New York territory 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. 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 again, particularly in pediatrics in the Seattle area, where Seattle Children's is a large account for us. So those are kind of our focused areas.

Nicholas Sherwood (Equity Analyst)

Okay, perfect. I really appreciate that detail. And then can you kind of just give me any more details you have on the integration with Rendiatek and how you've been able to present some of those offerings to your current customer base.

John Erb Newells

Actually have not introduced Rendiatek to the US Market yet. Rendiatek had two products, one which they have marketed before they went bankrupt, both international in the US and internationally. That was a urine collection used in critical care. They had a product in development that took just from the critical care hearing collection to actually monitoring kidney output. And that was really the target product that we saw great value in acquiring or India tech. So we have just completed that acquisition, brought the inventory that they had back into the US from Israel. It was an Israeli company. And we are now in development, on development, developing that more valuable product that was really the target of the acquisition. And 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, but they're also measuring urine output. They take urine samples, send it to the lab and get a lab report back. That gives them the 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 Rendia Tech does that at the bedside, so they get an immediate reading of those analytes or electrolyte balances in the urine. So it's going to be highly differentiated from anything that's on the market today. And we will introduce that product to the U.S. market in 2027.

Nicholas Sherwood (Equity Analyst)

Okay. And how many Aquadex units were you able to sell in the first quarter? 15. Okay. All right, well, those are all my questions and thank you for providing all that detail. And I'll return to the queue.

OPERATOR

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.

John Erb Newells

Thank you. We are encouraged by the progress made in the first quarter 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 Rendiatek, 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.

Disclaimer: This transcript is provided for informational purposes only. While we strive for accuracy, there may be errors or omissions in this automated transcription. For official company statements and financial information, please refer to the company's SEC filings and official press releases. Corporate participants' and analysts' statements reflect their views as of the date of this call and are subject to change without notice.