Nuwellis Inc (NUWE) 2025 Q3 法說會逐字稿

(Operator Instructions)

（操作說明）

Good day, everyone, and welcome to today’s Nuwellis Third Quarter 2025 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.

大家好，歡迎參加今天的Nuwellis 2025年第三季財報電話會議。目前，所有參與者均處於唯讀模式。稍後您或許有機會在問答環節提問。

Please note today's call will be recorded and I will be standing by should you need any assistance. It is now my pleasure to turn the conference over to Leah McMullen, Director of Communications. Please go ahead.

請注意，今天的通話將被錄音，如果您需要任何幫助，我將隨時待命。現在我很高興將會議交給傳播總監莉亞·麥克馬倫。請繼續。

Hi, thank you, operator, and good morning, everyone.

您好，謝謝接線員，大家早安。

Thank you for joining today's conference call to discuss Nuwellis financial results for the third quarter ended September 30th, 2025. With me on the call are John Erb, our Chairman of the Board and Chief Executive Officer, and Lynn Blake, who recently began consulting with us as our Interim Head of Finance.

感謝您參加今天舉行的電話會議，討論 Nuwellis 截至 2025 年 9 月 30 日的第三季財務業績。與我一起參加電話會議的還有我們的董事長兼執行長約翰·厄布，以及最近開始擔任我們臨時財務主管的林恩·布萊克。

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.

今天早些時候，我們發布了一份新聞稿，概述了我們本季的財務表現。如果您還沒有機會查看，可以在我們網站的投資者頁面上找到它。

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.

在開始之前，我想提醒大家，我們將在今天的電話會議上發表一些前瞻性聲明。這些聲明受 1995 年《私人證券訴訟改革法案》保護，並且基於當前的假設和估計。

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.

實際結果可能與所述結果有重大差異，我們建議您查看我們向美國證券交易委員會提交的文件中所列的風險因素。

The company assumes no obligation to update any forward-looking statements. Please do not place undue reliance on these statements. With that, I'll turn the call over to John Erb.

本公司不承擔更新任何前瞻性聲明的義務。請勿過度依賴這些說法。接下來，我將把電話交給約翰‧厄布。

Thank you, Leah and good morning, everyone. We entered the 3rd quarter with renewed momentum and sharper execution.

謝謝你，莉婭，大家早安。我們以全新的勢頭和更精準的執行力進入了第三季。

While Q2 was about stabilizing the business, Q3 was about progress, expanding adoption of Aquadex therapy, and advancing our leadership in precision fluid management across the cardiorenal continuum.

第二季的重點是穩定業務，而第三季的重點是取得進展，擴大 Aquadex 療法的應用，並鞏固我們在心腎疾病精準液體管理領域的領先地位。

Nuwellis is helping hospitals manage fluid balance in patients whose heart and kidney functions are closely connected. Our growth is anchored in three areas critical care, pediatrics, and heart failure, including hospital-based outpatient therapy, where our technology is driving real clinical and operational impact.

Nuwellis 正在幫助醫院管理心臟和腎臟功能密切相關的患者的體液平衡。我們的發展主要集中在三個領域：重症監護、兒科和心臟衰竭，包括醫院門診治療，在這些領域，我們的技術正在產生真正的臨床和營運影響。

In critical care, hospitals are adopting Aquadex because it helps achieve more consistent outcomes and streamlines postoperative and ICU fluid management. That confidence translated into stronger performance this quarter with year over year growth in circuit sales across all customer categories. Heart failure and critical care also saw higher console sales.

在重症監護領域，醫院正在採用 Aquadex，因為它有助於實現更一致的治療效果，並簡化術後和 ICU 液體管理。這種信心轉化為本季更強勁的業績，所有客戶類別的電路銷售額均實現了同比增長。心臟衰竭和重症監護類遊戲機的銷售量也更高。

The new 24-hour Aquadex circuit introduced in the US this quarter was designed for hospital-based outpatient use, supporting same day sessions and complementing our 72-hour inpatient option. Together this choice in circuits gives hospitals flexibility to match therapy to the care setting while maintaining consistency for patients and providers.

本季在美國推出的全新 24 小時 Aquadex 循環系統專為醫院門診使用而設計，支援當天療程，並補充了我們的 72 小時住院治療方案。這種迴路選擇使醫院能夠靈活地根據護理環境匹配治療方案，同時保持患者和醫護人員的一致性。

We also introduced a new dual-lumen extended length catheter expanding access options and compatibility across care environments. These innovations make therapy simpler and more comfortable for patients and more scalable for hospitals.

我們也推出了一種新型雙腔加長導管，擴大了導管接入選擇範圍，並提高了在不同護理環境中的相容性。這些創新使治療對患者來說更簡單、更舒適，對醫院來說也更具可擴展性。

In pediatrics, progress this quarter was transformative. Through our NAH-supported collaboration with Corona's biomedical Technologies, we're accelerating the development of Vivian, our dedicated pediatric CRRT system for children weighing between 2.5 and 20 kg.

本季度兒科領域取得了變革性的進展。透過 NAH 支持的與 Corona 生物醫學技術的合作，我們正在加速 Vivian 的開發，Vivian 是我們專為體重在 2.5 至 20 公斤之間的兒童設計的兒科 CRRT 系統。

A new US patent allowance and recent notice of allowance for another Vivian patent further demonstrated our commitment to innovation in pediatric fluid management. Additionally, clinical data from the Ultra Peds registry being prepared for publication shows 92% survival in children treated with Aquadex.

一項新的美國專利授權和最近另一項 Vivian 專利的授權通知進一步證明了我們對兒科液體管理創新的承諾。此外，Ultra Peds 註冊中心正在準備發表的臨床數據顯示，接受 Aquadex 治療的兒童的存活率為 92%。

In heart failure, we reached an important milestone with the first Aquadex therapy delivered in a hospital-based outpatient setting under the new CMS reimbursement code.

在心臟衰竭領域，我們取得了重要的里程碑，首次在醫院門診環境中根據新的 CMS 報銷代碼提供了 Aquadex 療法。

An early proof point of how this care model can extend therapy beyond inpatient admission and create a more proactive, accessible approach to fluid management.

初步證明，這種護理模式可以將治療延長至住院治療之外，並創造一種更積極、更易於獲得的液體管理方法。

Operationally, we advanced several important efforts initiating the transition of manufacturing to KDI precision manufacturing, exiting our European operations to sharpen US focus, and continuing disciplined capital deployment through two successful capital raises this year.

在營運方面，我們推進了幾項重要舉措，包括啟動向 KDI 精密製造的轉型、退出歐洲業務以加強對美國的關注，以及透過今年兩次成功的融資繼續進行有紀律的資本部署。

As we look ahead, we're building on this foundation, advancing precision fluid management across the cardiorenal continuum with a focus on clinical value, scalability, and growth.

展望未來，我們將以此為基礎，推動心腎疾病領域的精準液體管理，並專注於臨床價值、可擴展性和成長。

Q3 reflects real progress and growing momentum as aqueduct becomes an essential part of how hospitals manage fluid balance safely and effectively. With that, I'll turn the call over to our Interim Head of Finance, Lynn Blake, to review our financial results in more detail.

第三季反映了真正的進展和不斷增長的勢頭，因為輸水管已成為醫院安全有效地管理體液平衡的重要組成部分。接下來，我將把電話交給我們的臨時財務主管林恩·布萊克，讓她更詳細地回顧我們的財務表現。

Thank you, John, and good morning, everyone. Total revenue for the third quarter was $2.2 million a 6% decrease from the third quarter of 2024, primarily due to one-time prior year Seastar Medical Quellimune sales of approximately $200,000 and A decrease of approximately $100,000 in international revenues associated with the wind down of international operations in the current quarter.

謝謝你，約翰，大家早安。第三季總營收為 220 萬美元，比 2024 年第三季下降了 6%，主要原因是去年同期 Seastar Medical Quellimune 的一次性銷售額約為 20 萬美元，以及由於本季國際業務的逐步結束，國際收入減少了約 10 萬美元。

Also, lower console average selling prices. These impacts were partially offset by a 15% year over year increase in consumables utilization.

此外，遊戲機的平均售價也較低。這些影響被耗材利用率年增 15% 的部分抵消。

On a pro forma basis, revenue grew approximately 7% year over year after excluding the Seastar medical revenue in the prior year and the decrease in international revenue. Sequentially, revenue increased 29% from the second quarter, driven by a 23% increase in consumables utilization and a fourfold increase in US console sales.

以備考基準計算，剔除上一年 Seastar 醫療收入和國際收入的下降，營收年增約 7%。與第二季相比，營收季增 29%，主要得益於耗材使用量成長 23% 以及美國遊戲機銷量成長四倍。

By customer category, heart failure and critical care were 41% and 15% ahead of the prior year respectively, while pediatrics declined 7% largely due to lower console sales. All customer categories experienced year over year growth in circuit sales, with heart failure and critical care also benefiting from stronger console demand.

按客戶類別劃分，心臟衰竭和重症監護分別比上一年增長了 41% 和 15%，而兒科下降了 7%，這主要是由於遊戲機銷量下降所致。所有客戶類別的電路銷售額均同比增長，其中心臟衰竭和重症監護領域也受益於更強勁的控制台需求。

Gross margin for the quarter was 65.2% compared to 70% in Q3 of 2024. The gross margin rate decline was primarily due to under absorption of fixed overhead from lower production volumes earlier in the year, which flowed.

本季毛利率為 65.2%，而 2024 年第三季為 70%。毛利率下降主要是因為年初產量較低導致固定間接費用吸收不足所致。

Cost of sales in the current quarter as that inventory was sold, we do expect to realize incremental cost efficiency from the KDI manufacturing transfer beginning next year, which should support margin expansion once the transition is fully optimized.

本季銷售成本是由於庫存售出造成的，我們預計從明年開始，KDI 生產轉移將帶來增量成本效益，一旦過渡完全優化，這將支持利潤率的擴大。

Selling general and administrative expenses for the quarter were $3.5 million compared to $2.7 million in the same period last year. The increase reflects increased payroll and compensation expense associated with rebuilding our US sales force to historical headcount levels.

本季銷售一般及行政費用為 350 萬美元，去年同期為 270 萬美元。這一增長反映了為將美國銷售團隊重建至歷史人員規模水平而增加的工資和薪酬支出。

Research and development expenses were $603,000 compared to $486,000 last year, driven by an increase in expenses associated with continued investment in sustained engineering and our quality systems.

研發費用為 603,000 美元，而去年為 486,000 美元，這主要是由於持續投資於持續工程和品質系統的相關費用增加所致。

As a result of these investments in growth focused initiatives in our US business, total operating expenses for the quarter were $4.1 million in total, a 30% increase year over year. Operating loss for the quarter was $2.7 million compared to an operating loss of $1.5 million in Q3 of 2024.

由於我們對美國業務的成長重點舉措進行了這些投資，本季總營運支出為 410 萬美元，年增 30%。本季營業虧損為 270 萬美元，而 2024 年第三季營業虧損為 150 萬美元。

Net income attributable to common shareholders was $469,000 or $0.56 per share, compared to $2.4 million or $73.23 per share in the prior year quarter after giving effect to the company's reverse stock split, which became effective in July 2025. We ended the quarter with $3.1 million in cash and cash equivalents and remained debt-free.

歸屬於普通股股東的淨利潤為 469,000 美元，即每股 0.56 美元，而上年同期為 240 萬美元，即每股 73.23 美元（已計入公司於 2025 年 7 月生效的反向股票分割的影響）。本季末，我們持有現金及現金等價物 310 萬美元，且無任何債務。

The $1.9 million net equity raise in Q3 through our at the Market program combined with the $4 million net equity raise in June provides flexibility to support continued execution of our US revenue growth strategy and operating plan into 2026. With that, I'll turn the call back to John for closing remarks.

第三季透過我們的「市場融資計畫」籌集的 190 萬美元淨股權，加上 6 月籌集的 400 萬美元淨股權，為我們繼續執行美國收入成長策略和營運計畫到 2026 年提供了靈活性。接下來，我將把電話轉回給約翰，請他作總結發言。

Thanks, Lynn. As we look ahead, we're building a company at the center of cardiorenal care, one that unites technology, evidence, and access to deliver better outcomes for patients and hospitals alike. Our focus remains on three growth engines critical care, pediatrics, and hospital-based outpatient heart failure therapy.

謝謝你，琳恩。展望未來，我們將打造一家以心腎照護為核心的公司，將技術、證據和可及性結合起來，為病患和醫院帶來更好的結果。我們的重點仍然是三大成長引擎：重症監護、兒科和醫院門診心臟衰竭治療。

Together these areas are defining a new standard for precision fluid management and positioning Nuwellis for a long-term sustainable growth. Before we move into Q&A, I'd like to take a moment to recognize Rob Scott, who recently concluded his 12-year tenure here at Nuwellis.

這些領域共同定義了精密流體管理的新標準，並為紐威利斯的長期永續發展奠定了基礎。在進入問答環節之前，我想花一點時間向羅伯·斯科特致敬，他最近結束了在 Nuwellis 長達 12 年的任期。

Rob's leadership and dedication as Chief Financial Officer helped guide Nuwellis through significant transformation and growth. On behalf of the entire company, we thank him for his many contributions and wish him continued success in his new chapter. With that, I'll turn the call over to the operator to open the line for questions.

羅布作為財務長的領導和奉獻精神幫助 Nuwellis 實現了重大轉型和成長。我們謹代表公司全體員工，感謝他所做出的諸多貢獻，並祝福他在新的旅程中繼續取得成功。接下來，我將把電話轉交給接線員，以便接聽提問。

(Operator Instructions)

（操作說明）

And it does appear that there are no questions at this time. I would now like to turn the call back to management for any additional or closing remarks.

目前看來，似乎沒有任何問題。現在我想把電話轉回給管理階層，請他們補充或作總結發言。

Thank you. As we focus the company's efforts on delivering a strong 4th quarter, I'd like to thank all our Nuwellis employees, stockholders, physicians, nurses, patients, and healthcare workers for your continued support.

謝謝。在我們集中精力確保公司第四季度取得強勁業績之際，我要感謝所有 Nuwellis 的員工、股東、醫生、護士、患者和醫護人員的持續支持。

Thank you and have a great day.

謝謝，祝您今天過得愉快。

This does conclude today's program.

今天的節目到此結束。

Thank you for your participation. You may disconnect at any time and have a wonderful afternoon.

感謝您的參與。您可以隨時斷開連接，祝您下午愉快。