Nuwellis Q2 2026 Earnings Report

Nuwellis EPS Results

• Actual EPS: -$26.64
• Consensus EPS: -$23.80
• Beat/Miss: Missed by -$2.84
• One Year Ago EPS: N/A

Nuwellis Revenue Results

• Actual Revenue: $1.97 million
• Expected Revenue: $2.42 million
• Beat/Miss: Missed by -$446.00 thousand
• YoY Revenue Growth: N/A

Nuwellis Announcement Details

• Quarter: Q2 2026
• Date: 8/13/2026
• Time: Before Market Opens
• Conference Call Date: Thursday, August 13, 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 Q2 2026 Earnings Call Transcript

Key Takeaways

• Positive Sentiment: Second-quarter revenue rose 14% year over year to $1.97 million, with U.S. revenue up 17%; first-half revenue increased 20% to $4.37 million, driven by stronger U.S. growth and increased console placements.
• Positive Sentiment: Gross margin improved substantially to 76% from 56% a year ago, benefiting from higher average selling prices, favorable product mix, and the transition to contract manufacturing.
• Positive Sentiment: Nuwellis sold nine consoles in the quarter and 24 in the first half, versus five in the first half of 2025, while expanding pediatric programs and targeting greater recurring circuit utilization in pediatrics and adult critical care.
• Neutral Sentiment: The company plans to submit an FDA application in the fourth quarter to expand Aquadex use to patients weighing at least 5 kilograms, while Clarity Prime is targeted for launch in 2027 and new critical-care capabilities remain under development.
• Negative Sentiment: Despite the improved gross margin, Nuwellis reported a $4.8 million net loss and had only $3.9 million in cash at quarter-end; subsequent financings and warrant exercises raised approximately $6.7 million but may increase dilution.

Presentation

[Operator]

Good morning, and welcome to Nuwellis earnings conference call for the second quarter ended June 30, 2026. All participants are in listen-only mode. Should you need assistance, please signal a conferencing 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 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 at Nuwellis]

Thank you, operator. Thank you for joining today's conference call to discuss Nuwellis' Corporate Developments and Financial Results for the Second Quarter ended June 30, 2026. Joining me today are Mike McCormick, Nuwellis' newly appointed President and Chief Executive Officer, and Carisa Schultz, Chief Financial Officer. Earlier today, Nuwellis released its financial results for the second quarter of 2026. If you have not received the earnings release, please visit the investor 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 our expectations or predictions of future events and marketing 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.

[Leah McMullen, Director of Communications at Nuwellis]

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 Mike.

[Mike McCormick, President and CEO at Nuwellis]

Thank you, Leah, and good morning, everyone. I am pleased to be joining you for my first earnings call as CEO of Nuwellis. I would like to begin by thanking John Erb for his leadership and for the work he has done to position the company for its next phase. John has transitioned his executive role. However, he still remains as Chairman of our board. Personally, having served on the board since 2023 and closely working with the company on its commercial strategy, I enter this role with a clear understanding of Nuwellis' strengths and where greater focus can create meaningful value. We have established a commercial therapy addressing an important clinical need, a growing installed base, strong relationships with leading institutions, and a differentiated position in precision fluid management. My mandate is to turn those strengths into a growing, scalable, and financially disciplined business.

[Mike McCormick, President and CEO at Nuwellis]

We will do that by prioritizing three essential objectives. First, we intend to increase Aquadex utilization and recurrent circuit revenue by concentrating on accounts and clinical pathways where we can establish sustained use. Second, we intend to build our position in pediatrics and expand our presence in adult critical care, two areas where we see the strongest combination of clinical relevance and commercial traction as well as long-term growth opportunities. Third, we will endeavor to strategically broaden our cardiorenal platform through technologies and collaborations that complement the Aquadex, strengthen our existing customer relationships, and have a clear path toward commercial value. We believe the second quarter results showed progress across all of these priorities. An important commercial indicator of our continued expansion is the installed base.

[Mike McCormick, President and CEO at Nuwellis]

During the second quarter, we sold nine consoles, bringing the first half total to 24, compared with only five in the first half of 2025. Each of those placements expands the opportunity for recurrent circuit utilization. Our focus is now on helping all of those accounts translate the placements into sustained clinical use through training, protocol development, and early identification of appropriate patients. We will measure progress not only by the consoles placed but by the number of accounts achieving consistent utilization, the number of patients treated, and recurring circuit revenue generated from the installed base. Pediatrics remained the clearest example of this strategy in action. During the quarter, we expanded our presence in a major South Carolina healthcare system, and we expanded into two new states with the first pediatric programs in their history. We opened in Michigan and also in Wisconsin.

[Mike McCormick, President and CEO at Nuwellis]

We continue to strengthen the educational foundation supporting pediatric adoption. At the International Society for Heart and Lung Transplantation 46th Annual Meeting and Scientific Sessions, clinicians from the University of Iowa presented a case that highlighted the Aquadex use in managing recurrent fluid overload in a very complex pediatric cardiac patient. We also marked five years of support for the Pediatric Cardiac Critical Care Consortium, or PC4, a collaborative network focused on improving outcomes for critically ill pediatric cardiac patients. From a product standpoint, we continue to enhance the Aquadex platform with software updates designed to improve workflow efficiency, support treatment precision, and reduce barriers to therapy use. We also completed a pre-submission meeting with the FDA regarding a proposed expansion of the Aquadex indication for patients from 20 kg and above, which it is today, to patients weighing 5 kg and above.

[Mike McCormick, President and CEO at Nuwellis]

This meeting provided greater clarity regarding the proposed regulatory pathway. That includes bench testing, toxicology assessments, and supporting pediatric clinical evidence. We plan to submit the proposed label expansion to the FDA in the fourth quarter of this year. Together, these developments create a focused pediatric growth strategy, expand our commercial footprint, increase utilization within existing programs, improve products for smaller patients, and pursue a regulatory pathway that can meaningfully broaden the population that we serve. Critical care represents another significant opportunity for us. We recently announced the strategic development initiative to expand the capabilities of the Aquadex into broader extracorporeal therapy platform. These initiatives include higher flow capabilities designed to support new filtration technologies and expand the potential use of Aquadex in more complex critical care, high-pressure extracorporeal environments.

[Mike McCormick, President and CEO at Nuwellis]

We are also developing an enhanced user interface called SmartView that will make the Aquadex easier to use, improve clinical workflows, and support greater utilization. Together, these development programs are intended to broaden the capabilities of Aquadex and to strengthen our position in critical care. During the quarter, more than 280 physicians attended a critical care cardiac education summit that included hands-on training with the Aquadex. That created one of the largest concentrated physician training initiatives in the company's history. Our next step is to connect that growing clinical awareness with focused account development. We see an opportunity with our broader cardiorenal strategy to build from the same customer relationships and area of clinical expertise. The acquisition of Rendiatech in the first quarter of 2026 added ClarityPRIME, an automated kidney function monitoring system to our development portfolio.

[Mike McCormick, President and CEO at Nuwellis]

During the second quarter, our focus was on product development and technology integration and commercial planning. Aquadex gives clinicians the ability to remove excess fluid with precision. ClarityPRIME has the potential to provide earlier and more continuous insights, allowing early detection of changes in kidney function. We expect this important ClarityPRIME product to launch in 2027. Together, these technologies support stronger solutions to cardiorenal care in which clinicians can make better-informed decisions about fluid balance and kidney function. To further broaden our product offering and leverage our commercial infrastructure, we are evaluating complementary pediatric technologies, including pediatric urine output monitoring and pediatric non-invasive cardiac monitoring. Our approach will remain selective and capital efficient. We expect to only pursue technologies and collaborations that strengthen our position in pediatrics and critical care, complement the customer relationships we already have, and create a clear clinical and commercial benefit.

[Mike McCormick, President and CEO at Nuwellis]

During the quarter, we also received a notice of allowance from the United States Patent and Trademark Office for our dual lumen midline catheter technology. This intellectual property could support less invasive peripheral access for extracorporeal therapies, and it strengthens the technology foundation surrounding our fluid management platform. That patent, in fact, issued in mid-July. Excuse me. Capital discipline will remain central to the way that we operate. We intend to concentrate resources around Aquadex utilization, the proposed pediatric label expansion, focused development of ClarityPRIME, and selected strategic opportunities that directly support our strategy. Nuwellis has an established commercial foundation, differentiated strength in pediatrics, a growing traction in critical care, and a focused strategy to expand our role in cardiorenal care. While we do not provide formal financial guidance, our objectives remain clear.

[Mike McCormick, President and CEO at Nuwellis]

Deliver consistent double-digit revenue growth, maintain strong gross margins, increase our installed base and recurring circuit utilization, and advance our highest priority development programs to reduce and reduce cash utilization over time. In addition, through June financing and subsequent to the end-of-the-quarter financing events, we raised approximately $12.7 million in gross proceeds. That included $6 million in June. That was a private placement, and subsequent to the end of the quarter, we raised an additional $3.4 million from a registered direct offering and $3.3 million from warrant exercises. These actions strengthened our cash position, and it simplified our capitalization structure. With that, I am pleased to turn the call over to Carisa Schultz, who is our Chief Financial Officer, for a detailed review of our financial results. Carisa?

[Carisa Schultz, CFO at Nuwellis]

Thank you, Mike, and good morning. I will review our second quarter and year-to-date financial performance and balance sheet position. Revenue for the second quarter of 2026 was $1.97 million, compared with approximately $1.7 million in the prior year quarter, representing an increase of 14%, while U.S. revenue increased 17%. Revenue for the first six months of 2026 was $4.37 million, an increase of 20% from the prior year, while U.S. revenue increased 24%. Lower OUS service and rental revenue moderated reported growth, while U.S. revenue growth outpaced total company growth. During the quarter, the company sold nine U.S. consoles, compared with three in the second quarter of 2025. The new console placements, including within pediatric programs, expanded the installed base and created additional opportunities for sustained Aquadex utilization.

[Carisa Schultz, CFO at Nuwellis]

U.S. circuit average selling prices increased approximately 5% compared with the prior year quarter, and console average selling prices increased approximately 3%. These increases primarily reflect pricing adjustments implemented during the third quarter of 2025. Gross profit for the second quarter was approximately $1.5 million, resulting in a gross margin of 76%, compared with 56% in the prior year quarter. The 20 percentage point 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 second quarter were approximately $4.7 million, compared with approximately $3.9 million in the prior year quarter and approximately $6.3 million in the first quarter of 2026. The year-over-year increase primarily reflects investments supporting commercial expansion and product development initiatives. The sequential decrease reflects our continued effort to align expenses with the company's highest priority commercial and strategic programs.

[Carisa Schultz, CFO at Nuwellis]

Reported net loss for the second quarter was approximately $4.8 million, compared with approximately $12.6 million in the prior year quarter. The second quarter result included approximately $1.7 million of warrant valuation expense associated with the June 2026 financing. Following the effective date of the company's most recent reverse stock split on July 2nd, 2026, the related warrants were reclassified from liability to equity in early July. During June, the company completed a $6 million registered public offering. As of June 30th, 2026, the company had no debt, and cash and cash equivalents were approximately $3.9 million. As Mike previously mentioned, subsequent to quarter end, we further strengthened our balance sheet. In July, we raised an additional $3.4 million in gross proceeds through a registered direct offering and received $3.3 million from the cash exercise of warrants in connection with the June 2026 financing.

[Carisa Schultz, CFO at Nuwellis]

As we move through the second half of the year, our financial priorities remain focused on increasing recurring circuit revenue, maintaining gross margin discipline, 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 CEO at Nuwellis]

Thank you, Carisa Schultz. Before opening the call to questions, I want to reinforce the strategic direction we have outlined today. Nuwellis has an established commercial foundation with a clear pathway to growth. Our focus is to increase the Aquadex installed base, utilization, and recurrent circuit revenue within the accounts and clinical categories where we can establish sustained use. We intend to continue building differentiated position in pediatrics through commercial expansion, product improvements, clinical evidence, and proposed label expansion. We intend to grow our presence in adult critical care by connecting clinical education with focused account development and stronger pathways for Aquadex use. We are expected to selectively advance ClarityPRIME, our complementary technology that will broaden the relevance across fluid management and kidney function monitoring.

[Mike McCormick, President and CEO at Nuwellis]

These priorities are designed to create a stronger recurring revenue base, expand the patients and clinicians that we serve, as well as build more value in our cardiorenal platform. We will pursue them with a disciplined capital allocation and clear expectation of measurable progress. Operator, we would now like to open the call to any questions.

[Operator]

Thank you. If you would 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 one to ask a question. We will pause for just a moment to allow everyone a chance to join the queue. At this time, we have no questions in the queue. I will now turn the call back to Mike McCormick for concluding remarks.

[Mike McCormick, President and CEO at Nuwellis]

Thank you very much. We look forward to updating everyone on our progress and discussing our third quarter financial results on our next conference call that will be scheduled in November. 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.

Participants

Executives

• Leah McMullen, Director of Communications
• Mike McCormick, President and CEO
• Carisa Schultz, CFO