Nuwellis Q1 2026 Earnings Report

Nuwellis EPS Results

• Actual EPS: -$2.09
• Consensus EPS: -$1.00
• Beat/Miss: Missed by -$1.09
• One Year Ago EPS: N/A

Nuwellis Revenue Results

• Actual Revenue: $2.40 million
• Expected Revenue: $2.09 million
• Beat/Miss: Beat by +$309.00 thousand
• YoY Revenue Growth: N/A

Nuwellis Announcement Details

• Quarter: Q1 2026
• Date: 5/12/2026
• Time: Before Market Opens
• Conference Call Date: Tuesday, May 12, 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 Q1 2026 Earnings Call Transcript

Key Takeaways

• Positive Sentiment: Nuwellis said Q1 revenue rose 26% year over year to $2.4 million, driven by stronger console sales and a 15% increase in circuit sales as more patients were treated with Aquadex therapy.
• Positive Sentiment: Gross margin improved to 70.1%, which management attributed to better pricing, product mix, and the shift to contract manufacturing.
• Positive Sentiment: The company completed the Rendiatech acquisition to expand its cardiorenal platform, with management saying the technology could add bedside kidney-function monitoring and is targeted for a U.S. launch in 2027.
• Positive Sentiment: Pediatrics is becoming a major growth driver, now representing about 50% of U.S. revenue, with the footprint expanding to 47 centers including six top children's hospitals.
• Neutral Sentiment: Despite improving revenue and margins, operating expenses rose to about $6 million and the company reported a net loss of approximately $4.3 million, while ending the quarter with $2.2 million of cash and no debt.

Presentation

[Operator]

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

[Leah McMullen, Director of Communications at Nuwellis]

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.

[Leah McMullen, Director of 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 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.

[John Erb, Chairman of the Board, President and CEO at Nuwellis]

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.

[John Erb, Chairman of the Board, President and CEO at Nuwellis]

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.

[John Erb, Chairman of the Board, President and CEO at Nuwellis]

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.

[John Erb, Chairman of the Board, President and CEO at Nuwellis]

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.

[John Erb, Chairman of the Board, President and CEO at Nuwellis]

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.

[John Erb, Chairman of the Board, President and CEO at Nuwellis]

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.

[John Erb, Chairman of the Board, President and CEO at Nuwellis]

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.

[John Erb, Chairman of the Board, President and CEO at Nuwellis]

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.

[Carisa Schultz, CFO at Nuwellis]

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.

[Carisa Schultz, CFO at Nuwellis]

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.

[John Erb, Chairman of the Board, President and CEO at Nuwellis]

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.

[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, Analyst at Maxim Group]

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?

[John Erb, Chairman of the Board, President and CEO at Nuwellis]

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.

[John Erb, Chairman of the Board, President and CEO at Nuwellis]

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.

[Nicholas Sherwood, Analyst at Maxim Group]

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?

[John Erb, Chairman of the Board, President and CEO at Nuwellis]

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.

[John Erb, Chairman of the Board, President and CEO at Nuwellis]

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.

[Nicholas Sherwood, Analyst at Maxim Group]

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

[John Erb, Chairman of the Board, President and CEO at Nuwellis]

15.

[Nicholas Sherwood, Analyst at Maxim Group]

Okay. All right. Well, those are all my questions. Thank you for providing all that detail. 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, Chairman of the Board, President and CEO at Nuwellis]

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.

[Operator]

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

Participants

Executives

• Carisa Schultz, CFO
• John Erb, Chairman of the Board, President and CEO
• Leah McMullen, Director of Communications

Analysts

• Nicholas Sherwood, Analyst at Maxim Group