Nuwellis Inc (NUWE) 2025 Q2 法說會逐字稿

Good day, everyone, and welcome to today's Nuwellis' second-quarter 2025 earnings conference call. (Operator Instructions) Please note today's call will be recorded (Operator Instructions) It is now my pleasure to turn the conference over to Leah McMullen, Director of Communications. Please go ahead.

大家好，歡迎參加今天的 Nuwellis 2025 年第二季財報電話會議。（操作員指示）請注意，今天的通話將會被錄音（操作員指示）現在我很高興將會議交給通訊主管 Leah McMullen。請繼續。

Thank you, operator, and good morning, everyone. Thank you for joining today's conference call to discuss Nuwellis' financial results for the second quarter ended June 30, 2025.

謝謝接線員，大家早安。感謝您參加今天的電話會議，討論 Nuwellis 截至 2025 年 6 月 30 日的第二季財務業績。

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.

和我一起參加電話會議的還有我們的董事會主席兼執行長約翰·厄布 (John Erb) 和財務長羅布·斯科特 (Rob Scott)。今天早些時候，我們發布了一份新聞稿，概述了本季的財務表現。如果您還沒有機會查看它，您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. 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.

在我們開始之前，我想提醒大家，我們將在今天的電話會議上做出前瞻性的陳述。這些聲明受 1995 年《私人證券訴訟改革法》保護，並基於當前的假設和估計。實際結果可能與所描述的結果有重大差異，我們鼓勵您查看我們向美國證券交易委員會提交的文件中包含的風險因素。該公司不承擔更新任何前瞻性陳述的義務。請不要過度依賴這些聲明。

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

說完這些，我將把電話轉給約翰‧厄布 (John Erb)。

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 Nuwellis for growth and the opportunity to drive shareholder value.

謝謝你，利亞，大家早安。進入第二季度，我們專注於加強業務基礎、營運紀律、商業執行和策略投資，投資於我們認為最具影響力和成長機會的領域，我們相信所有這些都將為 Nuwellis 的成長和推動股東價值的機會奠定基礎。

Revenue for the second quarter was $1.7 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.

第二季營收為170萬美元，年減21%。雖然頂線反映了一些困難的阻力，但我想解決這些數字背後的背景。由於我們的消毒供應商存在行業問題，我們暫時積壓了約 40 萬美元的收入訂單。

During this time, our team acted quickly and decisively to prioritize our pediatric patients, ensuring that our most vulnerable patients received access to our life-saving therapy. I believe we successfully navigated this temporary setback. And importantly, in the first week of July, we fully reconciled this back order and are no longer in back order. This gives us a strong footing in entering Q3.

在此期間，我們的團隊迅速果斷地採取行動，優先考慮兒科患者，確保最脆弱的患者能夠接受我們的救命治療。我相信我們成功度過了這次暫時的挫折。更重要的是，在7月的第一周，我們完全解決了積壓訂單問題，目前已不再積壓訂單。這為我們進入第三季奠定了堅實的基礎。

I'll now break things down further by customer category. 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.

我現在將根據客戶類別進一步細分。我們的兒科業務仍然是公司的基石。我們持續看到現有醫院客戶對治療需求的強勁增長，而新中心也對尋求安全有效的治療方法感興趣，以治療無法忍受傳統腎臟替代療法的患者。Aquadex 仍然是美國僅有的兩種獲得 FDA 批准的能夠為體重低至 20 公斤的患者排出體液的設備之一，而這種差異化繼續轉化為臨床興趣和持續利用。

Within critical care, we saw increasing adoption as many of our accounts move from initial trialing into consistent practice. 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.

在重症監護領域，隨著許多帳戶從最初的試用階段轉向持續實踐，我們看到採用率不斷提高。我們的策略轉向為臨床團隊提供更深入的支持並與基於協議的液體管理保持一致，特別是在急性腎損傷造成嚴重風險的心臟手術後。

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. Based on these early learnings, we're refining our support tools and enhancing our site engagement program for the back half of the year.

在心臟衰竭方面，我們的努力越來越多地集中在門診機會上。隨著醫院準備開設專門的門診診所或擴大現有的心臟衰竭項目，Aquadex 正在展示其作為經濟高效的替代方案的價值。規模、人員配備和空間等方面都存在著明顯且合乎邏輯的挑戰。但我們將繼續直接與醫院合作解決這些問題。根據這些早期的經驗，我們將改進我們的支援工具並增強我們下半年的站點參與計劃。

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 12 months.

本季我們也實施了幾項重要的戰略決策。我們將繼續規劃從我們的製造業務向 KDI 精密製造業務的有序、高效過渡，並計劃於 10 月正式上線。我們預計此舉將在未來 12 個月內顯著提高營運效率並節省成本。

Additionally, we recently terminated the REVERSE-HF clinical trial. 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 million 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.

此外，我們最近終止了 REVERSE-HF 臨床試驗。雖然該研究旨在為住院心臟衰竭提供更多證據，但我們認為該指徵與我們的投資重​​點或其他足夠的近期商業機會不一致。透過結束試驗，我們可以重新分配先前預算的約 400 萬美元，用於支持 REVERSE-HF 向影響更大的成長領域發展。值得注意的是，我們終止這項上市後臨床研究的決定與設備性能或病人安全問題無關。

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 postoperative fluid overload and protect renal function. 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.

展望未來，我們的成長策略將集中在重症監護、兒科和門診心臟衰竭等心臟外科手術的關鍵領域。在心臟手術中，Aquadex 具有管理術後液體超負荷和保護腎功能的獨特能力。在兒科，Aquadex 仍然是一種可行的液體管理選擇，適用於許多腎功能很少或沒有腎功能的兒童。對於門診心臟衰竭患者，我們相信擴大報銷範圍和臨床需求為更廣泛地獲得安全有效的超濾鋪平了道路。

With that, I'll turn the call over to Rob Scott to walk through our financial results in more detail.

接下來，我將把電話轉給 Rob Scott，讓他更詳細地介紹我們的財務表現。

Thank you, John, and good morning, everyone. Total revenue for the second quarter was $1.7 million, down from $2.2 million in Q2 of last year. The decline was primarily driven by the temporary product back order described earlier.

謝謝你，約翰，大家早安。第二季總營收為 170 萬美元，低於去年第二季的 220 萬美元。下降的主要原因是前面描述的臨時產品積壓。

By customer category, Pediatric revenues increased 23% compared to the second quarter of 2024. Heart Failure and Critical Care revenue declined 53% and 35%, respectively, with the temporary back order having a significant impact. Gross margin for the quarter was 55.5% compared to 67.2% in Q2 2024. The margin impact was largely due to under-absorption of fixed overhead because of lower production volumes.

按客戶類別劃分，兒科收入與 2024 年第二季相比成長了 23%。心臟衰竭和重症監護收入分別下降53%和35%，其中臨時積壓訂單的影響顯著。本季毛利率為55.5​​%，而2024年第二季為67.2%。利潤率的影響主要是由於產量較低導致固定間接費用吸收不足。

Selling, general and administrative expenses for the quarter was $3.2 million, 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 $3.9 million, a 2% increase over prior year. Operating loss for Q2 was $2.9 million, compared to $2.3 million in Q2 2024.

本季銷售、一般及行政開支為 320 萬美元，與去年持平。研發費用為67.5萬美元，較去年同期的55.8萬美元略有增加。本季總營運費用為390萬美元，較上年同期成長2%。第二季的營業虧損為 290 萬美元，而 2024 年第二季的營業虧損為 230 萬美元。

Net loss attributable to common shareholders was $12.6 million, or a loss of $60.99 per share compared to a net loss attributable to common shareholders of $7.7 million or a loss of $791.82 per share for the same period in 2024. We ended the quarter with $4.5 million in cash and cash equivalents and remain debt free. The recent $5 million gross capital raise bolsters our financial position and provides us with flexibility to support our core growth initiatives.

歸屬於普通股股東的淨虧損為 1,260 萬美元，即每股虧損 60.99 美元，而 2024 年同期歸屬於普通股股東的淨虧損為 770 萬美元，即每股虧損 791.82 美元。本季末，我們擁有 450 萬美元的現金和現金等價物，並且沒有債務。最近籌集的 500 萬美元總資本增強了我們的財務狀況，並為我們支持核心成長計畫提供了靈活性。

With that, I'll turn the call back to John for closing remarks.

說完這些，我會把電話轉回給約翰，請他做最後發言。

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 and streamlining operations, every decision has been guided by a simple question, how do we deliver more value to patients, providers and importantly, our stockholders?

謝謝，羅布。我們相信，持續的成功需要有重點的策略和在必要時快速適應的能力。在過去的六個月裡，我們已經證明了我們這樣做的決心。從終止 REVERSE-HF 到轉變我們的製造合作夥伴和精簡運營，每個決定都由一個簡單的問題指導，我們如何為患者、供應商以及更重要的股東提供更多價值？

Looking ahead, we will continue to build on this disciplined execution. Our priorities are straightforward, progressing towards being cash flow positive, delivering on our commercial targets in 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.

展望未來，我們將繼續秉持這種嚴謹的執行態度。我們的優先事項很簡單，即逐步實現現金流為正，實現兒科和心臟外科的商業目標，深化門診患者對心臟衰竭計畫的參與，完成製造業轉型，並提高臨床對 Aquadex 在液體管理中的作用的認識。我們始終致力於擴大 Aquadex 的使用範圍，並建立一個產品組合，使臨床醫生能夠管理跨多種護理環境和患者類型的液體。

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. Go ahead operator.

我們仍處於成長階段，我們相信，眼前的機會是巨大的，我們相信，我們擁有策略、產品和團隊來取得有意義的成果。繼續吧，操作員。

(Operator Instructions) Anthony Vendetti, the Maxim Group.

（操作員指示）馬克西姆集團的安東尼·文德蒂。

You mentioned the issue with the vendor regarding sterilization and believe that accounts 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?

您提到了與供應商有關的消毒問題，並認為這導致了約 40 萬美元的收入。聽起來事情已經解決了。如果是，什麼時候解決的？這會對我們目前所處的第三季產生什麼影響嗎？

It was resolved in the first week of 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. The sterilization provider is back up and running with all of its chambers available to us. So fortunately, it's behind us.

這個問題在七月的第一周就得到了解決，而且我們也沒有積壓訂單。事實上，我們現在正在快速建立成品庫存，實際上是在為轉移到 KDI 製造公司做準備。所以這個問題已經過去了。消毒供應商已恢復正常運營，其所有消毒室均可供我們使用。幸運的是，這一切已經過去了。

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.

影響主要集中在心臟衰竭和心臟手術上，因為我們正在將庫存分配給兒科。正如羅布所說，我們第二季度的兒科銷售成長主要是因為需求和我們為他們提供產品。

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

好的。偉大的。那麼也許只是總體而言，隨著您看到業務的發展，約翰，也許只是—您現在認為最大的機會在哪裡？是小兒科嗎？是重症監護，還是心臟衰竭？還是三者兼有？那麼，您認為哪一個具體機會最多呢？

Well, I think it is all three. I think pediatrics, we 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, critical care, primarily in cardiac surgery, where physicians 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.

嗯，我認為三者都有。我認為在兒科方面，我們繼續增加兒童醫院作為客戶，因為他們採用 Aquadex 來照顧這些腎臟問題或功能不正常的小嬰兒。我們在心臟外科手術、重症監護（主要是心臟外科手術）領域不斷發展，醫生們看到了在開胸心臟手術後更有效地去除液體的機會，透過使用 Aquadex 去除液體，可以更快地將患者從呼吸機上取下並送出 ICU。所以這是兩個成長領域。

I think the faster-growing area is probably going to be heart failure because of the outpatient opportunity. As you probably remember earlier this year, we received an increase in our reimbursement from $413 a day to $1,639 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.

我認為，由於門診機會，成長較快的領域可能是心臟衰竭。您可能還記得，今年早些時候，對於在醫院門診接受治療的患者，我們的報銷金額從每天 413 美元增加到每天 1,639 美元。因此，目前我們有七、八家醫院正在建立這些診所。事實上，我們最近已經在 Prisma Richland 醫院治療了我們的第一位患者。所以——我認為，只要醫院利用增加的報銷額度，我們就會看到很大的成長。

And it does appear that there are no further questions at this time. (Operator Instructions) 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.

目前看來沒有其他問題了。（操作員指示）目前沒有其他問題。現在我想把發言權交還給管理階層，請他們發表任何補充或結束語。

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

好吧，我想感謝我們所有 Nuwellis 的員工、股東、醫生、護士、病人和醫護人員一直以來的支持。謝謝大家，今天就到這裡。

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

今天的節目到此結束。感謝您的參與。您可以隨時斷開連接，享受美好的一天。