Nuwellis Q2 2025 Earnings Report

Nuwellis EPS Results

• Actual EPS: -$60.99
• Consensus EPS: -$0.45
• Beat/Miss: Missed by -$60.54
• One Year Ago EPS: N/A

Nuwellis Revenue Results

• Actual Revenue: $1.73 million
• Expected Revenue: $2.20 million
• Beat/Miss: Missed by -$475.00 thousand
• YoY Revenue Growth: N/A

Nuwellis Announcement Details

• Quarter: Q2 2025
• Date: 8/12/2025
• Time: Before Market Opens
• Conference Call Date: Thursday, August 14, 2025
• 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 2025 Earnings Call Transcript

Key Takeaways

• Negative Sentiment: Revenue for Q2 fell 21% year-over-year to CAD 1.7 million and net loss widened to CAD 12.6 million, driven partly by operational headwinds.
• Positive Sentiment: A temporary CAD 400,000 sterilization vendor backorder was fully resolved in July, clearing the way for a stronger Q3 inventory position.
• Positive Sentiment: Pediatric revenues grew 23% year-over-year, fueled by sustained demand for Aquadex’s unique FDA-cleared ultrafiltration capabilities in smaller patients.
• Positive Sentiment: Newellis is transitioning manufacturing to KDI Precision in October, expecting significant operational efficiencies and cost savings over the next 12 months.
• Positive Sentiment: The balance sheet was bolstered with CAD 4.5 million in cash and a recent CAD 5 million capital raise, maintaining a debt-free position to fund growth initiatives.

Presentation

[Operator]

Good day, everyone, and welcome to today's Newellis Second Quarter twenty twenty five Earnings Conference Call. At this time, all participants are in a listen only mode. Later, you may have the opportunity to ask questions during the question and answer session. Please note, today's call will be recorded. It is now my pleasure to turn the conference over to Leah McMullen, Director of Communications. Please go ahead.

[Leah McMullen, Director - Communications & IR at Nuwellis]

Thank you, operator, and good morning, everyone. Thank you for joining today's conference call to discuss Newellis' financial results for the second quarter ended 06/30/2025. With me on the call are John Erb, our Chairman of the Board and Chief Executive Officer and Rob Scott, our Chief Financial Officer. Earlier today, we issued a press release that outlines our financial results for the quarter. If you haven't had the chance to review it, you can find it on the Investor page of our website.

[Leah McMullen, Director - Communications & IR at Nuwellis]

Before we begin, I'd like to remind everyone that we'll be making forward looking statements on today's call. These statements are protected under the Private Securities Litigation Reform Act of 1995 and are based on current assumptions and estimates. Actual results could differ materially from those described, and we encourage you to review the risk factors included in our filings with the Securities and Exchange Commission. The company assumes no obligation to update any forward looking statements. Please do not place any undue reliance on these statements.

[Leah McMullen, Director - Communications & IR at Nuwellis]

With that, I'll turn the call over to John Erbmann.

[John Erb, Chairman, President & CEO at Nuwellis]

Thank you, Leah, and good morning, everyone. We entered the second quarter focused on strengthening the fundamentals of our business, operational discipline, commercial execution and strategic investments in areas where we see the greatest opportunity for impact and growth, all of which we believe position Newellis for growth and the opportunity to drive shareholder value. Revenue for the second quarter was CAD1.7 million, a year over year decline of 21%. While the top line reflects some difficult headwinds, I want to address the context behind these numbers. Due to an industry wide issue with our sterilization vendor, we experienced a temporary back order of approximately $400,000 in revenue.

[John Erb, Chairman, President & CEO at Nuwellis]

During this time, our team acted quickly and decisively to prioritize our pediatric patients ensuring that our most vulnerable patients received access to our lifesaving therapy. I believe we successfully navigated this temporary setback. And importantly, in the July, we fully reconciled this backorder and are no longer in backorder. This gives us a strong footing entering Q3. I'll now break things down further by customer category.

[John Erb, Chairman, President & CEO at Nuwellis]

Our pediatrics business remains a cornerstone of the company. We continue to see strong demand for our established hospital customers and ongoing interest from new centers looking for a safe and effective therapy for patients who cannot tolerate traditional renal replacement modalities. Aquadex remains one of the only two FDA cleared devices in The US that enables fluid removal in patients weighing as little as 20 kilograms. And that differentiation continues to translate into clinical interest and sustained utilization. Within critical care, we saw increasing adoption as many of our accounts moved from initial trialing into consistent practice.

[John Erb, Chairman, President & CEO at Nuwellis]

Our strategy shifted to deeper support for clinical teams and alignment with protocol based fluid management, particularly post cardiac surgery where acute kidney injury poses serious risk. In heart failure, our efforts are increasingly centered on the outpatient opportunity. As hospitals prepare to launch dedicated outpatient clinics or expanding existing heart failure programs, Aquadex is showing its value as a cost efficient alternative. There are clear and logical challenges to scaling, staffing and space to name a few. But we continue to engage directly with hospitals working through these questions.

[John Erb, Chairman, President & CEO at Nuwellis]

Based on these early learnings, we're refining our support tools and enhancing our site engagement program for the back half of the year. We also implemented several important strategic decisions this quarter. We continue to plan for an orderly and efficient transition from our manufacturing to KDI precision manufacturing with go live planned for October. We expect this move to result in meaningful operational efficiencies and cost savings over the next twelve months. Additionally, we recently terminated the REVERSE HF clinical trial.

[John Erb, Chairman, President & CEO at Nuwellis]

While the study was designed to build additional evidence for inpatient heart failure, we believe this indication does not align with our investment focus or other sufficient near term commercial opportunities. By ending the trial, we can reallocate approximately $4,000,000 previously budgeted to support REVERSE HF toward higher impact growth areas. It is important to note that our decision to terminate this post market clinical study was not related to device performance or patient safety concerns. Looking ahead, our growth strategy is centered on the key areas of cardiac surgery within critical care, pediatrics and outpatient heart failure. In cardiac surgery, Aquadex offers unique ability to manage post operative fluid overload and protect renal function.

[John Erb, Chairman, President & CEO at Nuwellis]

In pediatrics, Aquadex remains a viable fluid management option for many children with little to no kidney function. And in outpatient heart failure, we believe that the expanded reimbursement and clinical need are paving the way for broader access to safe, effective ultrafiltration. With that, I'll turn the call over to Rob Scott to walk through our financial results in more detail.

[Rob Scott, CFO at Nuwellis]

Thank you, John, and good morning, everyone. Total revenue for the second quarter was $1,700,000 down from $2,200,000 in Q2 of last year. The decline was primarily driven by the temporary product backorder described earlier. By customer category, pediatric revenues increased 23% compared to the 2024. Heart failure and critical care revenue declined 5335% respectively, with the temporary backorder having a significant impact.

[Rob Scott, CFO at Nuwellis]

Gross margin for the quarter was 55.5% compared to 67.2% in Q2 twenty twenty four. The margin impact was largely due to under absorption of fixed overhead because of lower production volumes. Selling, general and administrative expenses for the quarter was $3,200,000 which is flat to last year. Research and development expense was $675,000 which is a slight increase compared to $558,000 in the same period last year. Total operating expenses for the quarter were $3,900,000 a 2% increase over prior year.

[Rob Scott, CFO at Nuwellis]

Operating loss for Q2 was $2,900,000 compared to $2,300,000 in Q2 twenty twenty four. Net loss attributable to common shareholders was $12,600,000 or a loss of $60.99 per share, compared to a net loss attributable to common shareholders of $7,700,000 or a loss of $791.22 per share for the same period in 2024. We ended the quarter with $4,500,000 in cash and cash equivalents and remain debt free. The recent $5,000,000 gross capital raise bolsters our financial position and provides us with flexibility to support our core growth initiatives. With that, I'll turn the call back to John for closing remarks.

[John Erb, Chairman, President & CEO at Nuwellis]

Thanks, Rob. We believe that sustained success requires both a focused strategy and the ability to adapt quickly when necessary. Over the past six months, we've demonstrated our commitment to doing just that. From terminating Reverse HF to transitioning our manufacturing partner extreme mining operations, every decision has been guided by a simple question, how do we deliver more value to patients, providers, and importantly, our stockholders? Looking ahead, we will continue to build on this disciplined execution.

[John Erb, Chairman, President & CEO at Nuwellis]

Our priorities are straightforward, progressing towards being cash flow positive, delivering on our commercial targets pediatrics and cardiac surgery, deepening outpatient engagement with heart failure programs, completing our manufacturing transition and driving increased clinical awareness of Aquadex's role in fluid management. We remain committed to expanding access to Aquadex and building a portfolio that enables clinicians to manage fluid across multiple care settings and patient types. We are still in our growth story and we are confident that the opportunities in front of us are substantial. And we believe we have the strategy, the product and the team to deliver meaningful results.

[Rob Scott, CFO at Nuwellis]

Go ahead, operator.

[Operator]

We'll move first to Anthony Benedetti with The Maxim Group. Your line is open.

[Anthony Vendetti, Executive MD - Research at Maxim Group]

Thank you. You mentioned the issue with the vendor or regarding sterilization and believe that account for around $400,000 in revenue. It sounds like that was resolved. If so, when was it resolved? And will there be any impact in the current third quarter that we're in?

[John Erb, Chairman, President & CEO at Nuwellis]

It was resolved in the July. And we've not been in back order. In fact, we're now building finished good inventory pretty rapidly. Actually building inventory to get ready for the transfer to KDI manufacturing. So the issue is behind us.

[John Erb, Chairman, President & CEO at Nuwellis]

The sterilization provider is back up and running with all of its chambers available to us. So fortunately, it's behind us. And the impact was primarily in heart failure and cardiac surgery, simply because we are allocating the inventory we had to pediatrics. And as Rob said, our pediatric volume in Q2 grew mostly just from demand and us having the product available for them.

[Anthony Vendetti, Executive MD - Research at Maxim Group]

Okay, great. And then maybe just in general, as you see the business evolve, John, and maybe just where do you see right now the largest opportunity? Is it pediatrics? Is it critical care? Heart failure?

[Anthony Vendetti, Executive MD - Research at Maxim Group]

Is it all three? And which one, though, specifically do you see the most opportunity?

[John Erb, Chairman, President & CEO at Nuwellis]

Well, I think it is all three. I think pediatrics, continue to add children's hospitals as customers as they adopt the Aquadex to take care of these small babies that have kidney issues or not functioning properly. We're growing in cardiac surgery, know, care primarily in cardiac surgery, where the patients are seeing the opportunity to get this fluid off after open heart surgery, much more efficiently get them off of the ventilator faster, and out of the ICU by taking the fluid off using Aquadex. So those are two growth areas. I think the faster growing area is probably going to be heart failure because of the outpatient opportunity.

[John Erb, Chairman, President & CEO at Nuwellis]

As you probably remember earlier this year, we received an increase in our reimbursement from $413 a day to $16.39 dollars a day for patients that are treated in a hospital outpatient clinic. So we have seven or eight hospitals today that are in the process of setting up these clinics. We've actually already treated our first patient most recently at Prisma Richland Hospital. So that I think we're going to see a lot of growth there just as hospitals take advantage of this increased reimbursement.

[Anthony Vendetti, Executive MD - Research at Maxim Group]

Okay, great. Thanks so much. I'll hop back in the queue.

[Operator]

And it does appear that there are no further questions at this time. But again, that is star and one. We'll pause just another moment. And there are no further questions at this time. I would now like to turn it back to management for any additional or closing remarks.

[John Erb, Chairman, President & CEO at Nuwellis]

Well, I'd like to thank all of our Newellis employees, stockholders, physicians, nurses, patients, and health care workers for your continued support. Thank you, and that's it for today.

[Operator]

This does conclude today's program. Thank you for participation. You may disconnect at any time and have a wonderful rest of your day. This

Participants

Executives

• Leah McMullen, Director - Communications & IR
• John Erb, Chairman, President & CEO
• Rob Scott, CFO

Analysts

• Anthony Vendetti, Executive MD - Research at Maxim Group