Nuwellis Inc (NUWE) 2025 Q1 法說會逐字稿

Good day, everyone, and welcome to Nuwellis first quarter 2025 earnings conference call. (Operator Instructions) Please note, this call is being recorded, and I will be standing by should you need any assistance.

大家好，歡迎參加 Nuwellis 2025 年第一季財報電話會議。（操作員指示）請注意，此通話正在錄音，如果您需要任何協助，我將隨時待命。

It is now my pleasure to turn today's program over to Louisa Smith with Investor Relations.

現在我很高興將今天的節目交給投資者關係部的 Louisa Smith。

Thank you, operator, and thank you for joining today's conference call to discuss Nuwellis' corporate developments and financial results for the first quarter ended March 31, 2025. In addition to myself, with us today on the call are John Erb, Nuwellis' Chairman of the Board and Interim CEO; and Rob Scott, Chief Financial Officer. At 8 AM Eastern Time today, Nuwellis released financial results for the first quarter of 2025. If you have not received Nuwellis' earnings release, please visit the Investors page on the company's website.

謝謝接線員，感謝您參加今天的電話會議，討論 Nuwellis 的公司發展和截至 2025 年 3 月 31 日的第一季度的財務業績。除了我自己之外，今天參加電話會議的還有 Nuwellis 董事會主席兼臨時執行長 John Erb 和財務長 Rob Scott。今天美國東部時間上午 8 點，Nuwellis 發布了 2025 年第一季的財務業績。如果您尚未收到 Nuwellis 的收益報告，請造訪公司網站上的投資者頁面。

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 expectations or predictions of future events and market trends as well as our estimated results or performance are forward-looking statements. All forward-looking statements are based on 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.

在本次電話會議中，本公司將發表前瞻性聲明。今天電話會議上所做的所有前瞻性陳述將受到 1995 年《私人證券訴訟改革法案》的保護。任何與未來事件和市場趨勢的預期或預測以及我們的估計結果或績效有關的陳述均為前瞻性陳述。所有前瞻性陳述均基於我們目前的估計和各種假設。這些聲明涉及重大風險和不確定性，可能導致實際結果或事件與這些前瞻性聲明預期或暗示的結果或事件有重大差異。

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 risk in the company's filings with the Securities and Exchange Commission, including the latest 10-K.

所有前瞻性陳述均基於目前可用的信息，本公司不承擔更新這些陳述的義務。因此，您不應過度依賴這些聲明。請參閱本公司向美國證券交易委員會提交的文件中（包括最新的 10-K）的警示聲明和風險討論。

With that, I would now like to turn the call over to John.

說完這些，我現在想把電話轉給約翰。

Thank you, Louisa, and good morning, everyone. Welcome to Nuwellis first quarter 2025 earnings conference call. Today, I'll walk through our first-quarter results, highlight key areas of growth and operational progress and share how we are building a strong foundation for long-term success. Next, our Chief Financial Officer, Rob Scott, will provide a detailed commentary on our financial results before opening up the call for questions.

謝謝你，路易莎，大家早安。歡迎參加 Nuwellis 2025 年第一季財報電話會議。今天，我將介紹我們的第一季業績，重點介紹成長和營運進展的關鍵領域，並分享我們如何為長期成功奠定堅實的基礎。接下來，我們的財務長 Rob Scott 將在開始提問之前對我們的財務結果進行詳細的評論。

We'll begin with an overview of the quarter. Nuwellis generated $1.9 million in revenue for the first quarter of 2025, representing a 3% increase year over year, supported by 4% increase in consumables utilization and an increase in US console sales, partially offset by a decrease in international sales. By customer category, we have had a strong quarter within pediatrics and heart failure, which saw 38% and 28% growth over prior year, respectively, driven by an increase in consumable utilization.

我們將首先概述本季的情況。Nuwellis 在 2025 年第一季創造了 190 萬美元的收入，年增 3%，這得益於耗材利用率增長 4% 以及美國遊戲機銷量增長，但國際銷量下降部分抵消了這一增長。按客戶類別劃分，本季我們在兒科和心臟衰竭領域的表現強勁，受消耗品利用率提高的推動，這兩個領域的業務分別比去年同期增長了 38% 和 28%。

Within pediatrics, we opened two new accounts during the quarter. Each of these additions underscores our strategic focus on the pediatrics category, or clinicians increasingly use Aquadex as a general alternative in cases where continuous renal replacement therapy or CRRT is not feasible due to the lower blood volumes and delicate hemodynamic balances required in pediatric patients. Sales in the critical care category decreased by 25% compared to the prior year. This decrease can be attributed primarily to one of our largest customers that acquired excess inventory at the end of '24.

在兒科領域，我們在本季開設了兩個新帳戶。每個新增功能都強調了我們對兒科類別的策略重點，或者在兒科患者血容量較低且需要精細的血流動力學平衡而無法進行連續腎臟替代療法或 CRRT 的情況下，臨床醫生越來越多地使用 Aquadex 作為一般替代方案。重症監護類別的銷售額與前一年相比下降了 25%。這一下降主要歸因於我們最大的客戶之一在 24 年底購買了過剩庫存。

This is a onetime impact, and we expect critical care to stabilize in the coming quarter. We continue to see positive trends in account penetration. Increasing clinical adoption, expanding reimbursement coverage, and enhanced physician advocacy continue to support a long-term growth and strategy.

這是一次性影響，我們預計重症監護將在下一季穩定下來。我們繼續看到帳戶滲透率的正面趨勢。增加臨床應用、擴大報銷範圍和加強醫生宣傳繼續支持長期成長和策略。

We continue to strengthen the clinical foundation supporting Aquadex therapy. Toward that end, the Journal of the American College of Cardiology Heart Failure published in February of this year included a reanalysis of data from the AVOID-HF trial, a randomized clinical trial evaluating ultrafiltration versus intravenous diuretics in patients with heart failure. This study demonstrated a 60% reduction in heart failure events with ultrafiltration at 30 days compared to standard intravenous [steroid] therapy and significantly fewer heart failure hospitalizations.

我們繼續加強支持 Aquadex 療法的臨床基礎。為此，今年 2 月出版的《美國心臟病學會心臟衰竭雜誌》對 AVOID-HF 試驗的數據進行了重新分析，這是一項隨機臨床試驗，評估超濾與靜脈利尿劑對心臟衰竭患者的影響。這項研究表明，與標準靜脈注射 [類固醇] 療法相比，使用超濾療法 30 天後心臟衰竭事件減少了 60%，心臟衰竭住院人數顯著減少。

In addition to these clinical trial findings, real-world data are also building an observation analysis titled Outcomes and Community Hospitals study led by Dr. John Jefferies evaluated the use of Aquadex across two regional hospitals. The study showed a statistically significant reduction in 60-day heart failure readmission rates, volume loss and weight reduction among patients treated with ultrafiltration, along with stable renal function and meaningful clinical benefit. These results reinforce the value of Aquadex in community-based care settings, where effective fluid management can have a substantial impact on patient outcomes and hospital resources. Together, these findings strengthened the clinical cadence for Aquadex across a range of hospital environments.

除了這些臨床試驗結果之外，真實世界數據也在建立一項觀察分析，題為“結果和社區醫院研究”，由約翰·杰弗里斯博士領導，評估了兩家地區醫院對 Aquadex 的使用情況。研究顯示，接受超濾治療的患者60天心臟衰竭再入院率、體積損失和體重減輕均顯著降低，同時腎功能穩定並獲得有意義的臨床益處。這些結果強化了 Aquadex 在社區護理環境中的價值，有效的液體管理可以對患者結果和醫院資源產生重大影響。總之，這些發現加強了 Aquadex 在各種醫院環境中的臨床節奏。

As I outlined on our fourth-quarter call, we have also seen important progress in reimbursement coverage that strengthens our commercial opportunities. Effective January 1, Aquadex was reassigned to a new outpatient reimbursed level by CMS, increasing the facility reimbursement fee for the therapy by nearly 4 times to $1,639 per day. This adjustment increases the accessibility and financial viability of Aquadex in hospital-based outpatient settings, thereby enabling hospitals to provide improved fluid management outcomes relative to diuretics.

正如我在第四季度電話會議上所概述的那樣，我們也看到報銷範圍方面取得了重要進展，這增強了我們的商業機會。從 1 月 1 日起，CMS 將 Aquadex 重新分配到新的門診報銷級別，該療法的設施報銷費用增加了近 4 倍，達到每天 1,639 美元。此項調整提高了 Aquadex 在醫院門診環境中的可及性和財務可行性，從而使醫院能夠提供相對於利尿劑更好的液體管理結果。

The combination of improved reimbursement and our expanding clinical evidence base is paving the way to advance our outpatient strategy. These enhancements allow us to expand our reach and use cases while leveraging the same call point as our core inpatient business.

報銷制度的改善和我們不斷擴大的臨床證據基礎的結合為推進我們的門診策略鋪平了道路。這些增強功能使我們能夠擴大覆蓋範圍和使用案例，同時利用與我們的核心住院業務相同的呼叫點。

Already, we see encouraging momentum in the outpatient setting, and expanded coverage makes Aquadex therapy more economically viable and accessible. We have built a growing pipeline of target outpatient facilities, representing an addressable market opportunity of approximately $773 million that we anticipate will help drive significant future top-line growth.

我們已經看到門診治療領域出現了令人鼓舞的發展勢頭，擴大覆蓋範圍使得 Aquadex 療法在經濟上更加可行，也更加易於獲得。我們已經建立了不斷增長的目標門診設施管道，代表著約 7.73 億美元的潛在市場機會，我們預計這將有助於推動未來顯著的營收成長。

Finally, before I turn the call over to Rob, I'd like to detail Nuwellis' current exposure to tariffs. At this point, we manufacture our products in-house at our facilities in Minnesota with only a very small portion of our raw materials being sourced internationally. Our limited exposure to international components leaves us confident we will not materially be affected by current tariff policies.

最後，在我將電話轉給 Rob 之前，我想詳細介紹 Nuwellis 目前面臨的關稅問題。目前，我們在明尼蘇達州的工廠內部生產我們的產品，只有極小一部分原料來自國際採購。我們對國際零件的有限接觸讓我們有信心不會受到當前關稅政策的重大影響。

I'd now like to turn it over to Rob to detail our Q1 financial results.

現在我想讓 Rob 詳細介紹我們的第一季財務表現。

Thank you, John, and good morning, everyone. Turning to the first-quarter financial results. Revenue was $1.9 million, representing a 3% increase over the prior year period. This growth was driven by a 4% increase in consumables utilization and an increase in US console sales, partially offset by a decrease in international sales.

謝謝你，約翰，大家早安。談到第一季的財務表現。營收為 190 萬美元，比去年同期成長 3%。這一增長得益於耗材利用率增長 4% 以及美國遊戲機銷量增長，但國際銷量下降部分抵消了這一增長。

By customer category, pediatric and heart failure revenues increased 38% and 28%, respectively, compared to the first quarter of 2024, supported by growth in consumables utilization. Critical Care revenue declined 25% year over year primarily due to the driver John referenced earlier.

按客戶類別劃分，受耗材利用率成長的推動，兒科和心臟衰竭收入與 2024 年第一季相比分別成長了 38% 和 28%。重症監護收入年減 25%，主要原因是約翰先前提到的驅動因素。

Gross margin for the first quarter was 56% compared to 64.1% in the same period last year. The decline was mainly driven by unfavorable manufacturing variances, lower fixed overhead absorption tied to reduced production volumes, and an inventory adjustment related to the FlexFlow console.

第一季毛利率為56%，去年同期為64.1%。下降的主要原因是製造差異不利、與產量減少相關的固定間接費用吸收降低以及與 FlexFlow 控制台相關的庫存調整。

Operating expenses continue to improve. Selling, general, and administrative expenses were $3.6 million, a 22% reduction compared to $4.6 million in the first quarter of 2024. The improvement reflects lower head count and compensation-related expenses, along with reduced professional services fees. Research and development expenses were $550,000 for the quarter compared to $1.3 million in the prior year period. This decrease was primarily due to lower head count and a reduction in R&D project spend.

營業費用持續改善。銷售、一般及行政費用為 360 萬美元，較 2024 年第一季的 460 萬美元減少 22%。這項改善反映了員工人數和薪酬相關費用的減少，以及專業服務費用的減少。本季研發費用為 55 萬美元，去年同期為 130 萬美元。這一下降主要是由於員工人數減少和研發項目支出減少。

In total, operating expenses for the quarter were $4.1 million, a 31% improvement compared to the first quarter of 2024. Operating loss narrowed to $3.1 million compared to an operating loss of $4.7 million in the prior year quarter. Net loss attributable to common shareholders was $3 million or a loss of $0.69 per share compared to a net loss attributable to common shareholders of $3.8 million or a loss of $24.11 per share for the same period in 2024.

總體而言，本季營運費用為 410 萬美元，與 2024 年第一季相比改善了 31%。營業虧損收窄至 310 萬美元，而去年同期的營業虧損為 470 萬美元。歸屬於普通股股東的淨虧損為 300 萬美元，即每股虧損 0.69 美元，而 2024 年同期歸屬於普通股股東的淨虧損為 380 萬美元，即每股虧損 24.11 美元。

At March 31, 2025, we ended the quarter with $2.6 million in cash and cash equivalents, and we continue to operate with no debt on the balance sheet. We remain focused on disciplined expense management and maintaining a strong financial position to support the continued expansion of our commercial initiatives.

截至 2025 年 3 月 31 日，我們在本季結束時擁有 260 萬美元的現金和現金等價物，我們繼續運營，資產負債表上沒有債務。我們將繼續專注於嚴格的費用管理並保持強勁的財務狀況，以支持我們商業計劃的持續擴展。

I'll now turn it back to John for additional remarks.

現在我將把話題轉回約翰，請他補充評論。

Thank you, Rob. We are excited to continue our progress into the year and capitalize on the positive momentum we've created in seeking to position Aquadex as a standard of care within fluid management. I would like to reiterate that Nuwellis is at a strategic inflection point. We are focusing on critical care, pediatrics, and outpatient heart failure. Critical care, primarily cardiac surgery, represents approximately 40% of our current business.

謝謝你，羅布。我們很高興能夠在今年繼續取得進展，並利用我們所創造的積極勢頭，力求將 Aquadex 定位為液體管理領域的護理標準。我想重申，努維利斯正處於戰略轉折點。我們專注於重症監護、兒科和門診心臟衰竭。重症監護，主要是心臟手術，約占我們目前業務的 40%。

Approximately 80% of the patients weaned from a heart-lung machine experience acute kidney injury due to the low hematocrit levels of diluted red blood cell counts. Aquadex can protect the kidneys by safely increasing hematocrit levels as excess fluid is removed post cardiac surgery. Aquadex has been used in 47 children's hospitals in the US and represents approximately 40% of our current business. Aquadex is a life-saving tool for pediatric nephrologist, treating children with little to no kidney function.

約 80% 脫離心肺機的患者因稀釋紅血球數的血球比容水平低而出現急性腎損傷。Aquadex 可以在心臟手術後去除多餘的液體，從而安全地增加血細胞比容水平，從而保護腎臟。Aquadex 已在美國 47 家兒童醫院使用，約占我們目前業務的 40%。Aquadex 是兒科腎臟病專家的救命工具，用於治療腎功能極弱或完全喪失的兒童。

With the recent fourfold increase in outpatient reimbursement and our growing partnerships with nephrologists, we will expand into the $773 million outpatient market as our current hospital accounts complete the logistical challenges of finding space and nursing resources. Treating heart failure patients in the hospital outpatient clinic will reduce the economic burden to hospitals of extended hospital stays and the penalties associated with 30-day readmission rates. The availability of hospital outpatient clinics will benefit heart failure patients where the chronic condition of fluid overload can be effectively managed and therefore, avoid the acute distress that requires the patient to be hospitalized.

隨著最近門診報銷金額增加了四倍，以及我們與腎臟科醫師的合作關係日益密切，我們將擴展到 7.73 億美元的門診市場，因為我們目前的醫院帳戶完成了尋找空間和護理資源的後勤挑戰。在醫院門診治療心臟衰竭患者將減少醫院因延長住院時間而產生的經濟負擔以及與 30 天再入院率相關的罰款。醫院門診的開設將使心臟衰竭患者受益，他們可以有效地控制液體超負荷的慢性狀況，從而避免需要住院治療的急性痛苦。

We are also engaging with a large nephrology company to contract hospital nephrology services to provide Aquadex for fluid management in hospital outpatient clinics. We are also continuing patient enrollment in our REVERSE-HF clinical study, which directly compares Aquadex to IV loop diuretics and reducing time to first heart failure event within 30 days. We're nearing the halfway mark toward our enrollment goal of 372 patients. We are shifting our customer focus to cardiac surgeons and perfusionists in critical care to pediatric nephrologists in the pediatric category and to nephrologists supporting the hospital outpatient-based centers.

我們還與一家大型腎臟病學公司合作，簽訂醫院腎臟病學服務合同，為醫院門診提供用於液體管理的 Aquadex。我們也將繼續招募患者參與我們的 REVERSE-HF 臨床研究，該研究直接比較 Aquadex 與靜脈袢利尿劑，並將首次心臟衰竭事件發生的時間縮短至 30 天內。我們招募 372 名患者的目標已接近一半。我們正在將客戶重點轉向重症監護的心臟外科醫生和灌注師、兒科的兒科腎臟病專家以及支持醫院門診中心的腎臟科專家。

We are diligently looking at ways to reduce our cash burn without jeopardizing our growth opportunities. I'm particularly pleased with our 31% reduction in operating expenses. Additionally, we have recently signed an agreement with KDI Precision Manufacturing, a well-known local contract manufacturing company to move manufacturing from our facility, which we believe can result in meaningful expense reductions over the next 12 months.

我們正在努力尋找在不危及成長機會的情況下減少現金消耗的方法。我對我們的營運費用減少了 31% 感到非常高興。此外，我們最近與當地知名合約製造公司 KDI Precision Manufacturing 簽署了一項協議，將製造業務從我們的工廠轉移出去，我們相信這可以在未來 12 個月內大幅降低費用。

We'll then look further at reducing additional operating expenses, including evaluating our future space requirements. We will continue to execute towards our inpatient and outpatient goals and will provide further details on our progress throughout the year.

然後，我們將進一步研究如何降低額外的營運費用，包括評估我們未來的空間需求。我們將繼續努力實現住院和門診目標，並將提供全年進展的更多詳細資訊。

This concludes our prepared remarks. Operator, we would now like to open the call to questions.

我們的準備好的演講到此結束。接線員，我們現在想開始提問。

(Operator Instructions) Jonathan Aschoff, Roth.

（操作員指示）喬納森·阿紹夫，羅斯。

Thanks. Thank you for going through the first quarter there. So if the pediatric revenue grew 38% year-on-year on flattish revenue, so the adult revenue must have dropped, and was that entirely due to lower international sales? Or was there lower sales domestically as well?

謝謝。感謝您參加第一季的活動。因此，如果兒科收入在收入持平的情況下同比增長 38%，那麼成人收入肯定下降了，這完全是由於國際銷售額下降造成的嗎？還是國內銷量也下降了？

And if you're addressing the drop in critical care, that was primarily due to our largest customer building their inventory in the fourth quarter of last year. So they didn't purchase as much in the first quarter. They have now begun repurchasing in the second quarter. So we expect our critical care business volume to kind of come back up to normal levels this quarter.

如果您要解決重症監護的下降問題，那主要是因為我們最大的客戶在去年第四季建立了庫存。因此他們在第一季的購買量沒有那麼多。他們現在已經從第二季開始回購。因此，我們預計本季重症監護業務量將恢復到正常水平。

Okay. Does that happen all the time because I've noticed that there is a drop in the first quarter? So it seems quite seasonal drop from the fourth and kind of bounces back in the second. So is this really just more of that seasonality?

好的。這種情況是否經常發生，因為我注意到第一季出現了下降？因此，從第四季度開始，它似乎出現了季節性下降，並在第二季度反彈。那麼這真的只是季節性現象嗎？

I would say there's not a lot of seasonality in our business. I think this was specific to a recall we had in the fourth quarter where this high-volume account wanted to make sure they protected their patient volume with the product and purchase it in the fourth quarter. So I think there was an incident that drove that change, and I think things will level out in the future.

我想說我們的業務沒有太多的季節性。我認為這與我們在第四季度的召回有關，當時這個大宗客戶希望確保他們能夠保護該產品的患者數量並在第四季度購買該產品。所以我認為有一個事件推動了這種變化，而且我認為事情將來會趨於平穩。

Thanks. So what has transpired at the relevant facility since the first of January? In other words, what does expanding the outpatient pipeline specifically mean for the outpatient application of Aquadex?

謝謝。那麼自一月一日以來相關設施發生了什麼事？換句話說，擴大門診治療管道對於 Aquadex 的門診應用具體意味著什麼？

Right. We're working currently right now with four hospitals that are wanting to implement their outpatient clinic and what they are working on basically is identifying the location for it. A couple of them have actually identified their hospital dialysis unit as the location and now they're working on getting the nursing resources necessary to support that outpatient clinic.

正確的。目前我們正在與四家想要開設門診診所的醫院合作，他們目前的工作主要是確定門診診所的位置。他們中的一些人實際上已經將醫院的透析科確定為地點，現在他們正在努力獲取支持該門診所需的護理資源。

So there's a little bit of a logistical change for hospitals to implement the outpatient clinic, and we're helping them and working through that. So that's the activity that's going on. We really expect these hospitals to start treating patients this quarter and start seeing revenue growth. We'll see a bit in the second quarter. We expect it to start growing more rapidly in the third and fourth quarter.

因此，醫院在實施門診時會在後勤方面發生一些變化，我們正在幫助他們並努力解決這個問題。這就是正在進行的活動。我們確實希望這些醫院本季開始治療患者並開始看到收入成長。我們將在第二季度看到一些結果。我們預計它將在第三季和第四季開始更加快速地成長。

Thank you. Lastly, can you help us better understand the Phase III trial enrollment with Aquadex? And the second part of that question is the Vivian clinical trial start timeline.

謝謝。最後，您能幫助我們更了解 Aquadex 的 III 期試驗招募嗎？問題的第二部分是 Vivian 臨床試驗的開始時間表。

Sure. The REVERSE-HF, we're continuing to enroll. Because of the fourth quarter recall that we went through. We've solved those problems and we purposely slowed down enrollment, just didn't push as patients came up, the physicians were still enrolling, but it slowed down a little bit. So we're now at -- we've solved those issues, by the way, and ready to start picking back up with our efforts to increase and drive enrollment.

當然。REVERSE-HF，我們正在繼續招生。因為我們經歷了第四季的召回。我們已經解決了這些問題，我們故意放慢了招生速度，只是沒有在病人出現時推動，醫生仍在招生，但速度放慢了一點。所以我們現在——順便說一下，我們已經解決了這些問題，並準備好重新開始努力增加和推動入學率。

So we're about halfway and continuing to work hard on that. The Vivian clinical trial, there's still a period that we'll go through with further development of the device itself, then we'll be ready to submit for an IDE clinical trial with the FDA. But I wouldn't say that the actual clinical trial will start until later this year, early next year.

所以我們已經完成了一半並將繼續努力。Vivian 臨床試驗，我們仍需要一段時間來進一步開發設備本身，然後我們才準備好向 FDA 提交 IDE 臨床試驗。但我不會說實際的臨床試驗要到今年稍後或明年年初才會開始。

That's very helpful. Thanks a lot, John.

這非常有幫助。非常感謝，約翰。

And we have no further questions at this time. I'll turn the program back over to John Erb for any additional or closing remarks.

目前我們沒有其他問題。我將把節目交還給約翰·厄布 (John Erb)，讓他做任何補充或結束語。

Thank you. I'd like to thank all of our stakeholders, Nuwellis employees, shareholders, physicians, nurses, patients, and healthcare workers in the field for their ongoing support. So thank you, and I hope you all have a great day.

謝謝。我要感謝我們所有的利害關係人、Nuwellis 員工、股東、醫生、護士、病人和該領域的醫療保健工作者的持續支持。所以謝謝你們，祝大家有個愉快的一天。

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

謝謝。今天的節目到此結束。感謝您的參與。您可以隨時斷開連接並享受美好的一天。