누웰리스(NUWE) 2026년 2분기 실적 발표 컨퍼런스 콜: 매출 14% 증가, 매출총이익률 76% 달성

핵심 요약

• 2026년 2분기 매출은 전년 동기 대비 14% 증가한 197만 달러를 기록했으며, 미국 매출은 17% 증가했습니다.
• 매출총이익률은 평균 판매 가격 상승, 우호적인 제품 믹스 및 위탁 생산으로의 전환에 힘입어 56%에서 76%로 확대되었습니다.
• 뉴웰리스는 미국에서 9대의 아쿠아덱스 콘솔을 판매해 전년 동기(3대) 대비 증가했습니다. 상반기 설치 대수는 2025년 상반기 5대에서 24대로 증가했습니다.
• 영업비용은 470만 달러로 전년 동기(390만 달러) 대비 증가했으나, 2026년 1분기(630만 달러)보다는 감소했습니다.
• 170만 달러의 워런트 평가 비용이 포함되었음에도 불구하고 순손실은 1,260만 달러에서 480만 달러로 축소되었습니다.
• 뉴웰리스는 6월 및 분기 이후 자금 조달 거래를 통해 총 약 1,270만 달러를 조달했습니다. 6월 말 기준 회사의 현금 및 현금성 자산은 390만 달러이며 부채는 없습니다.

주요 재무 데이터

사업 및 영업 실적

아쿠아덱스 설치 증가는 주요 성장 동력으로 유지되었습니다. 뉴웰리스는 이번 분기 미국에서 9대의 콘솔을 판매했으며, 이는 2025년 2분기 3대와 비교됩니다. 상반기 판매량은 총 24대로 전년 동기 5대에서 증가했습니다. 경영진은 초점이 단순 설치 대수 확대에서 벗어나 지속적인 고객 계정 활용, 환자 수 증가, 반복적인 서킷 매출 창출로 이동하고 있다고 밝혔습니다.

가격 정책 역시 실적을 뒷받침했습니다. 미국 내 서킷 평균 판매 가격은 전년 동기 대비 약 5% 상승했으며, 콘솔 평균 판매 가격은 약 3% 상승했습니다. 이는 주로 2025년 3분기에 시행된 가격 변경이 반영된 결과입니다.

소아과 분야는 계속해서 우선 과제로 유지되었습니다. 뉴웰리스는 사우스캐롤라이나주의 주요 의료 시스템 내 입지를 확장하고 미시간주와 위스콘신주에서 첫 소아과 프로그램을 구축했습니다. 회사는 아쿠아덱스의 적응증을 체중 20kg 이상 환자에서 최소 5kg 이상 환자로 확대하는 건과 관련해 FDA와 사전 제출 미팅을 완료했습니다.

중환자 치료 분야에서는 280명 이상의 의사가 실습 중심의 아쿠아덱스 교육이 포함된 교육 서밋에 참석했습니다. 뉴웰리스는 또한 워크플로우를 개선하고 복잡한 중환자 치료 환경에서 더욱 광범위하게 활용될 수 있도록 고유량 기능 및 스마트뷰(SmartView) 사용자 인터페이스를 개발 중입니다.

회사는 렌디아텍(Rendiatech) 인수를 통해 추가된 자동 신장 기능 모니터링 시스템인 클래리티 프라임(Clarity Prime)의 개발 및 통합 작업을 이어갔습니다. 경영진은 이 제품이 2027년에 출시될 것으로 예상합니다. 7월 중순에는 뉴웰리스의 이중 루멘 정중 카테터 기술에 대한 특허가 등록되었습니다.

경영진 전망

뉴웰리스는 공식적인 재무 가이던스를 제시하지 않았습니다. 경영진은 지속적인 두 자릿수 매출 성장, 견조한 매출총이익률, 설치 기반 확대, 반복적인 서킷 활용도 증가, 장기적인 현금 소진 감소를 핵심 목표로 제시했습니다.

회사는 2026년 4분기에 아쿠아덱스 소아 적응증 확대 신청서를 FDA에 제출할 계획입니다. 경영진은 규제 승인 절차에 벤치 테스트, 독성 평가 및 이를 뒷받침하는 소아 임상 증거가 포함된다고 설명했습니다.

자본 배분은 아쿠아덱스 활용도 증대, 소아 적응증 확대, 클래리티 프라임 개발, 그리고 회사의 소아과 및 중환자 치료 전략을 보완할 엄선된 기술 또는 협력에 집중될 예정입니다.

리스크 및 주목 요소

• 뉴웰리스는 계속해서 순손실을 기록하고 있어 현금 소진 감소를 최우선 과제로 두고 있습니다.
• 미국 외 지역 매출은 서비스 및 임대 매출 감소의 영향을 받아 회사 전체의 성장세를 완화시켰습니다.
• 영업비용은 상업화 확대 및 제품 개발 투자로 인해 전년 동기 대비 높은 수준을 유지했습니다.
• 제안된 소아 적응증 확대안은 추가 시험, 임상 증거 및 FDA 검토를 거쳐야 합니다.

실적 발표 컨퍼런스 콜 전문

전체 실적 발표 컨퍼런스 콜 녹취록

경영진 발표

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.