Nuwellis (NASDAQ:NUWE) reported third-quarter financial results on Thursday. The transcript from the company’s third-quarter earnings call has been provided below.
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Summary
Nuwellis reported a 70% gross margin for Q3 2026, a 5% increase from the previous year, attributed to higher selling prices and contract manufacturing benefits. Operating expenses decreased by 13% year-over-year, contributing to a 24% improvement in operating loss and emphasizing disciplined spending.
The company sold 32 Aquadex consoles in the first nine months of 2026, an 88% increase compared to the same period in 2025, highlighting a strong expansion of their installed base. Pediatric net sales grew 20% in Q3 and 26% year-to-date, with strategic milestones like the UltraPeds Registry publication and an FDA 510(k) application submitted for broader pediatric use.
Nuwellis entered into agreements with Atrility Medical and Xoroflo to expand its product portfolio, leveraging existing commercial infrastructure for new pediatric technologies. The Aquadex SmartVue and Pressure IQ are expected to launch in 2027, with ongoing development of Clarity Prime for potential new applications.
Cash reserves were strengthened to $8.3 million, with a financial runway projected through Q2 2027, supported by strategic capital raises. The company’s future outlook remains optimistic with strategic growth in pediatrics, new product launches, and expanded market presence anticipated for 2027.
Full Transcript
OPERATOR
To begin, good morning and welcome to Nuwellis’ third quarter 2026 financial results and business update conference call. All participants will be in a listen-only mode. Should you need assistance, please signal a conference specialist by pressing the star key followed by zero. After today’s presentation, there will be an opportunity to ask questions. To ask a question, you may press star then one on your telephone keypad. To withdraw your question, please press star then two.
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 the 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.
Leah McMullen (Director of Communications)
Thank you, operator. Thank you for joining today’s conference call to discuss Nuwellis’ corporate developments and financial results for the third quarter of 2026. Joining me today are Mike McCormick, Nuwellis’ President and Chief Executive Officer, and Carisa Schultz, Chief Financial Officer. Earlier today, Nuwellis released its third quarter 2026 financial results. If you have not received the earnings release, please visit the Investors page of 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 their 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 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 Mike McCormick, Nuwellis’ CEO.
Mike McCormick (President and Chief Executive Officer)
Thank you, Leah, and good morning, everyone. On our last conference call, I outlined three priorities for Nuwellis. First, to increase Aquadex utilization and recurring circuit revenue. Second, to build on our strong position in pediatrics and expand our presence in adult critical care. And third, to strategically broaden our cardiorenal platform through technologies and collaborations that complement Aquadex and leverage our existing customer relationships.
From a financial standpoint, we made meaningful progress in the quarter improving our operating performance. The third quarter gross margin expanded 430 basis points while operating expenses declined 13% year over year, resulting in a 24% improvement in operating loss. These results reflect our continued focus on disciplined spending and improved operating efficiency and directing resources toward the highest-priority growth initiatives. The expansion of our installed base remains one of our most important indicators of our commercial progress. During the first nine months of 2026, we sold 32 Aquadex consoles. That’s an 88% increase compared with 17 consoles during the same period last year. In the third quarter, we sold eight consoles compared to 12 in the prior-year quarter. Every console added to our installed base expands the opportunity for recurring circuit revenue, and our teams remain focused on increasing utilization across our existing hospital customers.
We had a strong first half of 2026, and while the second half of the year faces more challenging comparisons against a strong second half in 2025, we remain encouraged by the underlying momentum of our business. The third quarter comparison was particularly challenging because last year we benefited from approximately $400,000 in accumulated backorders that were fulfilled during the quarter. Excluding that unusual benefit, the underlying performance grew 20% and continues to demonstrate positive momentum going forward.
As we have said over the course of the last two quarters, pediatric remains our growth driver. Pediatric net sales increased 20% in the third quarter and 26% year to date compared with other periods. We also achieved two important milestones in our pediatric strategy. First, the results of the UltraPeds Registry, a multi-center study titled Kidney Support in Infants and Children Using Aquadex: Findings from the UltraPeds Registry, were accepted for publication in a leading peer-reviewed journal, Pediatric Nephrology.
This is an important scientific publication for Nuwellis. The study evaluated 91 pediatric patients treated with Aquadex across seven children’s hospitals, with 62% of the patients weighing less than 10 kilograms. Importantly, 87% of those patients survived their Aquadex treatment course, and 86.5% of those procedures were completed without interruption. Beyond these clinical findings, the publication played a really important role in our regulatory strategy. The UltraPeds data served as a cornerstone to our pre-submission meeting with the FDA, allowing us to use peer-reviewed scientific clinical journals as well as real-world evidence to support our proposed expansion of the Aquadex pediatric indication. Following these discussions, on November 5th we submitted to the FDA a 510(k) application to expand the Aquadex SmartFlow System indication from patients weighing 20 kg and above to patients weighing as low as 5 kg and above.
If cleared, this expanded indication would allow us to serve a significantly broader pediatric population, increase access for existing customers, and create opportunities for adoption at additional children’s hospitals. Our third priority is focused on broadening the product offering for our cardiorenal platform. On our last call I mentioned that we were evaluating some complementary pediatric technologies that could leverage our commercial infrastructure. I am pleased to say that we have delivered on that commitment with two agreements to add to our existing portfolio. In August, we entered into a co-promotion and distribution agreement with Atrility Medical for its AtriAmp post-operative cardiac rhythm monitoring device.
AtriAmp is a natural fit for our pediatric and critical care sales force, which already calls on cardiac surgery and critical care teams who care for these patients. We’re off to a strong start; within the short time since signing the agreement, our teams have already completed multiple sales and service calls together, and customer response has been very encouraging. We have a growing pipeline of accounts that are actively in process, which positions us well for growth as we move into 2027.
I’m also pleased to announce that earlier this week we secured exclusive U.S. distribution rights for the pediatric Xoroflo external urine collection system. Accurate urine output measurement is central to fluid management in critically ill children, and Xoroflo complements our clinical workflows around the Aquadex therapy. We expect to launch this product in the first quarter of 2027. Together, these agreements expand our product portfolio without significant capital required and leverage our existing commercial team and customer relationships.
Turning to our internal development programs, we continue to make strong progress on several initiatives designed to expand the capabilities of our Aquadex platform. Aquadex SmartVue, our next-generation user interface, is currently under development with an expected launch in the first quarter of 2027. SmartVue is designed to improve the user experience and provide a foundation for future enhancements to the Aquadex system. We are also making strong progress on Aquadex Pressure IQ, which is being developed to expand operating capabilities of Aquadex across additional patient conditions and clinical settings.
We expect Pressure IQ to launch in the first half of 2027. In addition, development of Clarity Prime, our automated kidney function monitoring technology acquired through Indiotech, continues to advance. We believe this unique technology has potential applications beyond kidney function monitoring, and we are evaluating opportunities to incorporate its capabilities into other products and clinical applications. Together, these programs reflect our continued commitment to innovation, expanding the clinical utility of Aquadex, and creating additional long-term opportunities for our technology platform.
In October, we participated in four medical conferences spanning pediatrics, critical care, and heart failure. Most notable of those four conferences is the American Society of Nephrology’s Kidney Week. Fluid overload is a common challenge across all three markets, and these meetings let our team engage directly with clinicians treating these patients. Our focus is to turn that engagement into new accounts and increase Aquadex utilization. Finally, capital discipline remains central to how we operate. As I mentioned, we reduced operating expenses both year over year and sequentially, and our gross margin expanded to 70% in the quarter, reflecting higher average selling prices and continued benefits of our contract manufacturing model. We strengthened our balance sheet during the quarter, and we ended the period with $8.3 million in cash and cash equivalents, providing runway through the second quarter of 2027.
With that, I will turn the call over to Carisa Schultz, our Chief Financial Officer, to review our financial results.
Carisa Schultz (Chief Financial Officer)
Thank you, Mike, and good morning. I will review our third quarter and year-to-date financial performance and balance sheet position. Revenue for the third quarter of 2026 was $2.2 million, unchanged from the prior-year quarter. As Mike mentioned, the prior-year quarter was a challenging comparison period as it included approximately $0.4 million in backorder fulfillment. Sequentially, third quarter revenue increased approximately 12% from the second quarter of 2026.
Revenue for the first nine months of 2026 was $6.6 million, an increase of 13% from the prior year, driven by growth in U.S. circuit and console sales. Pediatric net sales increased 20% in the third quarter and 26% for the first nine months compared with the prior-year periods. In the first nine months of 2026, we sold 32 consoles compared with 17 in the prior-year period, an 88% increase. During the quarter, the company sold eight Aquadex consoles compared with 12 in the third quarter of 2025.
Gross profit for the third quarter of 2026 was approximately $1.5 million, resulting in a gross margin of 70% compared with 65% in the prior-year quarter. The gross margin improvement was driven by higher circuit and console average selling prices, favorable product mix, and the benefits of our transition to contract manufacturing. Operating expenses for the third quarter were approximately $3.6 million compared with approximately $4.1 million in the prior-year quarter and approximately $4.7 million in the second quarter of 2026. The year-over-year decrease primarily reflects reductions in administrative costs and lower sales-related compensation. The sequential decrease reflects our continued efforts to align expenses with the company’s highest-priority commercial and strategic programs.
The combination of gross margin expansion and disciplined expense management resulted in a 24% year-over-year improvement in operating loss, from approximately $2.7 million to $2.1 million. We remain focused on reducing operating expenses and cash utilization while continuing to invest in commercial and development programs that offer the greatest potential for long-term growth. Reported net loss for the third quarter was approximately $2 million compared with net income of approximately $0.5 million in the prior-year quarter. The prior-year result included a significant non-cash gain associated with changes in the fair value of warrant liabilities.
Turning to the balance sheet, as of September 30, 2026, the company had cash and cash equivalents of approximately $8.3 million, with runway through the second quarter of next year. During the third quarter, we raised $3.4 million in gross proceeds through a registered direct offering in July and concurrently received $3.3 million in gross proceeds from the cash exercise of warrants. We also received $1.4 million in net proceeds from common shares sold under our at-the-market program.
Looking ahead, our financial priorities remain unchanged: increasing recurring circuit revenue, reducing cash utilization, and directing capital toward the commercial and development programs with the greatest potential to create value. That concludes my prepared remarks. I will now turn the call back to Mike.
Mike McCormick (President and Chief Executive Officer)
Thank you, Carisa. Before opening the call to questions, I want to take a second and just summarize where Nuwellis stands. Year to date we have grown by double digits, nearly doubled our unit console sales, and significantly expanded our gross margin while reducing operating expenses and strengthening our balance sheet. In pediatrics, we have strengthened our clinical foundation with the UltraPeds peer-reviewed publication, and we built on that evidence by submitting our 510(k) seeking expanded indications for the Aquadex to patients weighing as little as 5 kg. We are also advancing our product development pipeline with SmartVue and Pressure IQ that are expected to launch in 2027, while continuing to develop Clarity Prime and exploring additional applications for that technology.
And we broadened our commercial portfolio with agreements with Atrility Medical and Xoroflo, adding complementary products that leverage our existing sales force and customer relationships in a capital-efficient way. We believe this progress positions Nuwellis for sustained growth and long-term value creation for patients, customers, and shareholders. We remain focused on disciplined execution and delivering measurable progress against each of these priorities. Operator, we would now like to open the call to any questions.
OPERATOR
Thank you. And if you would like to ask a question, please press star one on your keypad. To leave the queue at any time, press star two. Once again, that is star one to ask a question, and we will pause for a moment to allow everyone a chance to join the queue. And once again, that is star one if you would like to ask a question. We’ll pause for another moment. And at this time we show no questions in queue. I will now turn the call back to Mike for some concluding remarks.
Mike McCormick (President and Chief Executive Officer)
Thank you. We appreciate everybody’s participation today and updating you on the third quarter results. We look forward to continuing to update you on our progress and discussing the fourth quarter financial results at our next conference call early next year. Thank you again for joining us today.
OPERATOR
Thank you. This brings us to the end of today’s meeting. We appreciate your time and participation. You may now disconnect.
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.