Nuwellis (NUWE) Earnings Call Q2 2026: Umsatz steigt um 14 %, Bruttomarge erreicht 76 %

Wichtigste Erkenntnisse

• Der Umsatz im zweiten Quartal 2026 stieg im Jahresvergleich um 14 % auf 1,97 Millionen US-Dollar, während der US-Umsatz um 17 % zulegte.
• Die Bruttomarge verbesserte sich von 56 % auf 76 %, unterstützt durch höhere durchschnittliche Verkaufspreise, einen vorteilhaften Produktmix und den Übergang zur Auftragsfertigung.
• Nuwellis verkaufte in den USA neun Aquadex-Konsolen, verglichen mit drei im Vorjahreszeitraum. Im ersten Halbjahr wurden 24 Systeme platziert, verglichen mit fünf im ersten Halbjahr 2025.
• Die Betriebsausgaben beliefen sich auf 4,7 Millionen US-Dollar und lagen damit über dem Vorjahreswert von 3,9 Millionen US-Dollar, aber unter den 6,3 Millionen US-Dollar des ersten Quartals 2026.
• Der Nettoverlust verringerte sich von 12,6 Millionen US-Dollar auf 4,8 Millionen US-Dollar, obwohl darin Aufwendungen für die Bewertung von Optionsscheinen in Höhe von 1,7 Millionen US-Dollar enthalten waren.
• Nuwellis erzielte bis Ende Juni und durch Finanzierungstransaktionen nach Quartalsende einen Bruttoerlös von rund 12,7 Millionen US-Dollar. Das Unternehmen schloss den Monat Juni mit liquiden Mitteln in Höhe von 3,9 Millionen US-Dollar und ohne Finanzverbindlichkeiten ab.

Wichtige Finanzdaten

Geschäfts- und operative Entwicklung

Die Platzierungen von Aquadex-Systemen blieben ein zentraler Wachstumstreiber. Nuwellis verkaufte im Quartal neun Konsolen in den USA, verglichen mit drei in Q2 2025. Die Platzierungen im ersten Halbjahr beliefen sich auf insgesamt 24 Konsolen, verglichen mit fünf im Vorjahr. Das Management gab bekannt, dass sich der Fokus von reinen Platzierungen hin zu einer nachhaltigen Kundennutzung, höheren Patientenzahlen und wiederkehrenden Umsätzen mit Schlauchsets verschiebt.

Die Preisgestaltung stützte das Ergebnis ebenfalls. Die durchschnittlichen Verkaufspreise für Schlauchsets in den USA stiegen im Jahresvergleich um etwa 5 %, während die durchschnittlichen Verkaufspreise für Konsolen um ca. 3 % zulegten. Dies spiegelt hauptsächlich die im dritten Quartal 2025 umgesetzten Preisanpassungen wider.

Die Pädiatrie blieb ein Schwerpunkt. Nuwellis expandierte innerhalb eines großen Gesundheitssystems in South Carolina und richtete seine ersten pädiatrischen Programme in Michigan und Wisconsin ein. Das Unternehmen schloss ein Pre-Submission-Meeting mit der FDA bezüglich einer geplanten Erweiterung der Aquadex-Indikation von Patienten mit einem Gewicht von mindestens 20 Kilogramm auf Patienten ab fünf Kilogramm ab.

In der Intensivmedizin nahmen mehr als 280 Ärzte an einem Schulungsgipfel teil, der praktische Aquadex-Trainings umfasste. Zudem entwickelt Nuwellis Kapazitäten für höhere Durchflussraten sowie eine SmartView-Benutzeroberfläche, um Arbeitsabläufe zu verbessern und eine breitere Anwendung in komplexen Intensivpflege-Umgebungen zu unterstützen.

Das Unternehmen setzte die Entwicklungs- und Integrationsarbeiten für Clarity Prime fort, das automatisierte System zur Überwachung der Nierenfunktion, das im Zuge der Übernahme von Rendiatech hinzukam. Das Management rechnet mit der Markteinführung des Produkts im Jahr 2027. Mitte Juli wurde ein Patent für die Dual-Lumen-Midline-Kathetertechnologie von Nuwellis erteilt.

Ausblick des Managements

Nuwellis gab keine formelle Finanzprognose ab. Als Kernziele nannte das Management ein anhaltend zweistelliges Umsatzwachstum, starke Bruttomargen, den Ausbau der installierten Basis, eine höhere wiederkehrende Nutzung der Schlauchsets und einen im Zeitverlauf geringeren Mittelabfluss.

Das Unternehmen plant, den Antrag auf Erweiterung der Indikation von Aquadex für den pädiatrischen Bereich im vierten Quartal 2026 bei der FDA einzureichen. Laut Management umfasst der Zulassungsweg Labortests, toxikologische Bewertungen und ergänzende pädiatrisch-klinische Nachweise.

Die Kapitalallokation wird sich auf die Aquadex-Nutzung, die Erweiterung der pädiatrischen Indikation, die Entwicklung von Clarity Prime sowie ausgewählte Technologien oder Kooperationen konzentrieren, die die Strategie des Unternehmens in den Bereichen Pädiatrie und Intensivmedizin ergänzen.

Risiken und Beobachtungspunkte

• Nuwellis weist weiterhin einen Nettoverlust aus und räumt der Reduzierung des Mittelabflusses Priorität ein.
• Der Umsatz außerhalb der USA wurde durch geringere Service- und Vermietungseinnahmen beeinträchtigt, was das unternehmensweite Wachstum dämpfte.
• Die Betriebsausgaben blieben im Jahresvergleich aufgrund von Investitionen in die Vertriebsexpansion und Produktentwicklung auf erhöhtem Niveau.
• Die geplante Erweiterung der pädiatrischen Indikation unterliegt weiterhin zusätzlichen Tests, klinischen Nachweisen und der Prüfung durch die FDA.

Vollständiges Transkript der Telefonkonferenz zu den Quartalszahlen

Vollständiges Transkript der Telefonkonferenz

Ausführungen des Managements

Operator

Good morning, and welcome to Nuwellis Earnings Conference Call for the Second Quarter ended June 30, 2026. [Operator Instructions] 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 1 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

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 Executive -- Chief Executive Officer; and Carisa Schultz, Chief Financial Officer. Earlier today, Nuwellis released 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.

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 undue reliance on these statements. Please refer to the cautionary statements and discussion of risks 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.

Michael McCormick

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 2003 -- '23 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. 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. 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 remain the clearest example of this strategy in action. During the quarter, we expanded our presence in a major South Carolina health care system. And we expanded into two new states with the first pediatric programs in their history. We opened in Michigan and also in Wisconsin.

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 5 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 complement our -- we also completed a pre-submission meeting with the FDA regarding a proposed expansion of the Aquadex indication for patients from 20 kilograms and above, which it is today, to patients weighing five kilograms and above. 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 pursuing a regulatory pathway that can meaningly -- meaningfully broaden the population that we serve. Critical care represents another significant opportunity for us.

We recently announced the strategic development initiatives 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. 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 broader -- with our broader cardiorenal strategy to build from the same customer relationships in the area of clinical expertise. The acquisition of Rendiatech in the first quarter of 2026 added Clarity Prime, an automated kidney function monitoring system, to our development portfolio. During the quarter -- or 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. Clarity Prime has the potential to provide earlier and more continuous insights, allowing changes in -- early detection of changes in kidney function. We expect this important Clarity Prime 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.

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 decline -- our 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 Clarity Prime 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: 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 simplifies 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

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 6 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. 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.

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 2, 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 30, 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.

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 towards 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.

Michael McCormick

Thank you, Carisa. 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. We focus -- our focus is to increase the Aquadex installed base, utilization and recurrent circuit revenue within the account 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. And we are expected to selectively advance Clarity Prime, our complementary technology that will broaden the relevance across fluid management and kidney function monitoring.

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

[Operator Instructions] At this time, we have no questions in the queue. I will now turn the call back to Mike McCormick for concluding remarks.

Michael McCormick

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.