Nuwellis (NUWE) 2026 年第二季財報電話會議：營收成長 14%，毛利率達 76%

重點摘要

• 2026 年第二季營收年增 14% 至 197 萬美元，其中美國市場營收成長 17%。
• 受惠於平均銷售單價提高、有利的產品組合以及轉向委外代工製造，毛利率從 56% 擴增至 76%。
• Nuwellis 在美國售出 9 台 Aquadex 主機，高於前一年的 3 台。上半年裝機量達 24 台，而 2025 年上半年則為 5 台。
• 營業費用為 470 萬美元，高於前一年的 390 萬美元，但低於 2026 年第一季的 630 萬美元。
• 儘管包含 170 萬美元的認股權證評價費用，淨虧損仍自 1260 萬美元收窄至 480 萬美元。
• Nuwellis 截至 6 月及季後透過融資交易募集約 1270 萬美元總收益。截至 6 月底，該公司擁有 390 萬美元現金且無負債。

關鍵財務數據

業務與營運表現

Aquadex 的裝機量仍是核心成長動力。Nuwellis 本季在美國售出 9 台主機，而 2025 年 Q2 則為 3 台。上半年銷售總計 24 台主機，高於前一年的 5 台。管理層表示，其重點正從單純的裝機量轉向持續的客戶利用率、患者人數以及經常性管路組營收。

產品定價亦對業績形成支撐。美國管路組平均銷售單價年增約 5%，而主機平均銷售單價增加約 3%，主要反映了 2025 年第三季實施的價格調整。

兒科領域仍是重點業務。Nuwellis 拓展了南卡羅來納州大型醫療系統的業務，並在密西根州和威斯康辛州建立了首批兒科計畫。該公司已與 FDA 完成預備提交流程會議，內容涉及擬將 Aquadex 的適應症範圍從體重至少 20 公斤的患者擴大至體重至少 5 公斤的患者。

重症護理方面，超過 280 名醫師參加了包含 Aquadex 實機操作培訓的教育峰會。Nuwellis 也在開發更高流量的功能以及 SmartView 使用者介面，旨在改善工作流程，並支援在複雜的重症護理環境中更廣泛地應用。

該公司繼續進行 Clarity Prime 的開發與整合工作，該自動化腎功能監測系統是透過收購 Rendiatech 所獲得。管理層預計該產品將於 2027 年推出。一項涵蓋 Nuwellis 雙腔中長天期導管技術的專利已於 7 月中旬獲批。

管理層展望

Nuwellis 未提供正式的財務指引。管理層將持續的雙位數營收成長、強勁的毛利率、裝機規模擴大、更高的經常性管路組利用率以及長期降低現金使用率列為核心目標。

該公司計劃於 2026 年第四季向 FDA 提交擬議的 Aquadex 兒科標籤擴充申請。管理層表示，監管途徑包括台架測試、毒理學評估及支持性兒科臨床證據。

資本配置將著重於 Aquadex 的利用率、兒科標籤擴充、Clarity Prime 開發，以及補充公司兒科與重症護理策略的特定技術或合作。

風險與關注事項

• Nuwellis 繼續報告淨虧損，並將降低現金消耗列為優先事項。
• 美國以外地區的營收受服務和租賃營收下降影響，放緩了全公司的成長力道。
• 受商業拓展與產品開發投資影響，營業費用仍高於去年同期。
• 擬議的兒科適應症擴展仍需視補充測試、臨床證據及 FDA 審查而定。

法說會完整逐字稿

完整財報電話會議逐字稿

管理層陳述

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.