Nuwellis Inc (NUWE) 2023 Q3 法說會逐字稿

Good day, and welcome to the Nuwellis third-quarter 2023 earnings conference call. (Operator Instructions) Please note this event is being recorded.

美好的一天，歡迎參加 Nuwellis 2023 年第三季財報電話會議。 （操作員說明）請注意此事件正在被記錄。

I would now like to turn the conference over to Vivian Cervantes, Investor Relations with Gilmartin Group, please go ahead.

現在我想將會議轉交給吉爾馬丁集團投資者關係部門維維安·塞萬提斯 (Vivian Cervantes)，請繼續。

Thank you, Danielle, and thank you, everyone, for joining us in today's conference call to discuss Nuwellis's corporate developments and financial results for the third quarter ended September 30, 2023. In addition to myself, with us today are Nestor Jaramillo, Nuwellis's President and CEO; and Rob Scott, CFO. We also have Dr. John Jefferies, Nuwellis's Chief Medical Officer joining us today.

謝謝丹妮爾，謝謝大家參加今天的電話會議，討論 Nuwellis 截至 2023 年 9 月 30 日的第三季度的公司發展和財務業績。除了我自己，今天與我們在一起的還有 Nuwellis 總裁 Nestor Jaramillo和首席執行官；和財務長羅布·斯科特。今天還有 Nuwellis 首席醫療官 John Jefferies 博士加入我們。

At 8 AM, Eastern today, Nuwellis released financial results for the quarter ended September 30, 2023. If you have not received Nuwellis's earnings release, please visit the Investors page of the company's website.

今天東部時間上午 8 點，Nuwellis 發布了截至 2023 年 9 月 30 日的季度財務業績。如果您尚未收到 Nuwellis 的收益報告，請訪問該公司網站的投資者頁面。

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.

在本次電話會議期間，該公司將做出前瞻性聲明。今天電話會議期間所做的所有前瞻性陳述都將受到 1995 年私人證券訴訟改革法案的保護。

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 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.

任何與對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相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。這些陳述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陳述預期或暗示的結果或事件有重大差異。

All forward looking statements are based upon currently 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 SEC, including the latest 10-K and subsequent reports.

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陳述。請參閱該公司向 SEC 提交的文件中的警告聲明和風險討論，包括最新的 10-K 和後續報告。

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

至此，我現在想將電話轉給內斯特。

Thank you, Vivian, and good morning, everyone. Welcome to Nuwellis's third-quarter 2023 earnings conference call.

謝謝你，維維安，大家早安。歡迎參加 Nuwellis 2023 年第三季財報電話會議。

For our call today, I will provide an overview of our third quarter performance and give an update on our strategic initiatives, including our supply and collaboration agreement with DaVita. And our exclusive license and distribution agreement with SeaStar for its selective cytopheretic device or SCD, which recently received an FDA approvable letter for use in pediatric acute kidney injury under a proposed humanitarian device exemption.

在今天的電話會議中，我將概述我們第三季的業績，並介紹我們策略計畫的最新情況，包括我們與 DaVita 的供應和合作協議。我們與 SeaStar 就其選擇性細胞分離裝置或 SCD 達成了獨家許可和分銷協議，該裝置最近收到了 FDA 的批准函，可根據擬議的人道主義裝置豁免用於治療兒科急性腎損傷。

Dr. John Jefferies, our Chief Medical Officer, will also add additional color on our DaVita collaboration and our clinical programs, and will provide his perspective on recent news affecting the renal industry. Our Chief Financial Officer, Rob Scott, will then provide detailed commentary on the financial results before opening the call up for questions followed by my closing remarks.

我們的首席醫療官 John Jefferies 博士也將為我們的 DaVita 合作和臨床計畫增添更多色彩，並將就影響腎臟產業的最新新聞發表他的觀點。然後，我們的財務長 Rob Scott 將在開始提問之前對財務業績提供詳細評論，隨後我將發表結束語。

Before I turn to third-quarter results, I would like to acknowledge concerns about the current market situation and its effect on companies like Nuwellis. The reason I feel confident in the future of Nuwellis is because we have three fundamentally sound short-term growth drivers. First, we have our organic business, which is growing, represented by five consecutive quarters of year-over-year growth in our core heart failure business. Second is the expected commercialization of three new products within the next two years. And third is our supply and collaboration agreement with DaVita.

在討論第三季業績之前，我想承認對當前市場狀況及其對 Nuwellis 等公司影響的擔憂。我對 Nuwellis 的未來充滿信心，因為我們有三個基本上健全的短期成長動力。首先，我們的有機業務正在成長，以我們的核心心臟衰竭業務連續五個季度同比增長為代表。其次是預計未來兩年內三種新產品的商業化。第三是我們與 DaVita 的供應和合作協議。

Turning first to our organic growth and third quarter results. In the third quarter of 2023, Nuwellis generated $2.4 million in revenue, a 17% increase versus the third quarter of 2022 and a 16% increase over the prior quarter. What is most relevant in our view is therapy utilization or the number of circuits (technical difficulty) console, which increased 26% over same period last year, reflecting continued increase in the number of patients being treated with the Aquadex therapy. Last quarter in Q2, the utilization was 14%.

首先談談我們的有機成長和第三季業績。 2023 年第三季度，Nuwellis 營收 240 萬美元，比 2022 年第三季成長 17%，比上一季成長 16%。我們認為最相關的是治療利用率或電路（技術難度）控制台的數量，比去年同期增加了 26%，反映出接受 Aquadex 治療的患者數量持續增加。第二季上個季度的利用率為 14%。

By customer category, we are pleased to see firm growth across each of the three category targets. With third quarter 2023 revenue in heart failure posting a 27% increase over the same period last year. Critical Care, a 16% increase and pediatrics, a 9% increase. Higher console sales led the heart failure growth, while utilization gains drove critical care and pediatric performance.

按客戶類別劃分，我們很高興看到三個類別目標均達到穩健成長。 2023 年第三季心臟衰竭領域的營收較去年同期成長 27%。重症監護增加 16%，兒科增加 9%。控制台銷售的增加帶動了心臟衰竭的成長，而利用率的提高則推動了重症監護和兒科的表現。

We continue to attribute a strong organic growth, especially in heart failure, through the growing awareness of our clinical data and support from multiple peer-reviewed publications over the past 18 months, validating the clinical and economic benefits of the Aquadex therapy. We are focused on driving awareness among clinicians and providers to help them understand that ultrafiltration through the use of the Aquadex system is the logical step when diuretics are not working and should be implemented earlier in the care pathway. Patients for whom oral or intravenous diuretics are not effective, should immediately move to the mechanical fluid ultrafiltration therapy, which is more controllable, precise, and predictable. This is the message that our field organization is consistently delivering and is having positive results.

我們繼續將強勁的有機成長歸功於過去 18 個月中我們的臨床數據意識的不斷提高以及多個同行評審出版物的支持，尤其是在心臟衰竭方面，驗證了 Aquadex 療法的臨床和經濟效益。我們致力於提高臨床醫生和醫療服務提供者的認識，幫助他們了解，當利尿劑不起作用時，使用 Aquadex 系統進行超濾是合乎邏輯的步驟，應在護理路徑中儘早實施。口服或靜脈注射利尿劑無效的患者應立即轉向機械液體超濾治療，這種治療更可控、更精確、更可預測。這是我們的現場組織始終如一地傳遞的訊息，並且正在取得積極的成果。

I would like to point out that our installed base measured by placed Aquadex consoles is key for Nuwellis because it generates revenue quickly and is a leading indicator for growth in utilization of the therapy. The more consoles we place, the more patients are treated. With that, although our installed base in Q3 grew, we also continue to see lumpiness in hospital capital spending trends. Hospitals across multiple geographies are still facing capital budget constraints.

我想指出的是，我們透過放置的 Aquadex 控制台衡量的安裝基礎對於 Nuwellis 來說至關重要，因為它可以快速產生收入，並且是治療利用率成長的領先指標。我們放置的控制台越多，接受治療的患者就越多。因此，儘管我們在第三季的安裝基礎有所增長，但我們也繼續看到醫院資本支出趨勢的波動。多個地區的醫院仍面臨資本預算限制。

As we navigate this environment, we are pleased to offer both rental programs and console sales, all while driving increased utilization in our systems. For example, in the first half of this year, our sales of consoles were soft, but our revenue rent -- our rental revenue increased by 36%. However, in Q3, our sales of consoles grew sequentially, but our rental revenue was soft. The good news is that hospitals are getting around the capital budget constraints by renting consoles while still growing the number of patients treated with the Aquadex therapy. We will continue to monitor hospital capital spending, especially in light of an elevated interest rate environment.

當我們在這種環境中航行時，我們很高興提供租賃計劃和控制台銷售，同時提高我們系統的利用率。例如，今年上半年，我們的遊戲機銷售疲軟，但我們的租金收入增加了 36%。然而，在第三季度，我們的遊戲機銷量環比成長，但我們的租賃收入卻疲軟。好消息是，醫院正在透過租賃控制台來繞過資本預算限制，同時仍增加接受 Aquadex 療法治療的患者數量。我們將繼續監控醫院資本支出，特別是考慮到利率上升的環境。

Our second growth driver is our expected new product introductions within the next two years. We are excited that SeaStar medical recently received the FDA approvable letter for its selective cytopheretic device or SCD, where we are exclusive US distribution rights for the use in pediatric acute kidney injury patients. We are even more excited about the pooled analysis from two non-controlled clinical studies, showing that pediatric patients over 10 kilograms with acute kidney injury requiring continuous kidney replacement therapy treated with SeaStar's SCD, had a 77% reduction in mortality and zero dialysis dependency at day 60 and zero device related serious adverse events or infections.

我們的第二個成長動力是我們預計在未來兩年內推出的新產品。我們很高興 SeaStar Medical 最近收到了 FDA 對其選擇性細胞分離裝置或 SCD 的批准函，我們擁有該裝置在美國的獨家經銷權，用於兒童急性腎損傷患者。我們對兩項非對照臨床研究的總結分析感到更加興奮，該分析顯示，體重超過10 公斤、需要持續腎臟替代治療的急性腎損傷兒科患者接受SeaStar SCD 治療後，死亡率降低了77%，並且透析依賴性為零。第 60 天，零設備相關的嚴重不良事件或感染。

Turning to our internal product development program, also earmarked for our high growth pediatric patient category. We continue to advance development of our pediatric continuous kidney replacement therapy device, which is complementary to the SeaStar SCD therapy. We along with many pediatric nephrologists, believe this product will have a profoundly positive impact in survival and significantly improve the quality of life of neonates and small children with kidney malfunction, kidney issues or those born without kidneys. We are executing to plan, to continue, and continue to expect IDE approval in the first half of 2024, with full FDA clearance and commercial launch in the US early in 2025.

談到我們的內部產品開發計劃，該計劃也專門用於我們高成長的兒科患者類別。我們繼續推進兒科連續腎臟替代治療設備的開發，該設備是 SeaStar SCD 療法的補充。我們與許多兒科腎病專家一起相信，該產品將對患有腎功能障礙、腎臟問題或出生時沒有腎臟的新生兒和幼兒的生存產生深遠的積極影響，並顯著改善他們的生活品質。我們正在執行計劃，繼續執行，並繼續期望 IDE 在 2024 年上半年獲得批准，並於 2025 年初在美國獲得 FDA 的全面批准和商業推出。

Finally, we continue to move forward with our supply and collaboration agreement with DaVita to pilot Aquadex ultrafiltration to treat adult patients with congestive heart failure and related conditions in selected US markets. In pairing the Aquadex system with DaVita's care team, we aim to expand ultrafiltration therapy to many of the heart failure patients in the US suffering from fluid overload and unresponsive to diuretics. We are actively engaged in finalizing treatment pathways and pilot study sites.

最後，我們繼續推進與 DaVita 的供應和合作協議，在選定的美國市場試點 Aquadex 超濾來治療患有充血性心臟衰竭和相關疾病的成年患者。透過將 Aquadex 系統與 DaVita 的護理團隊結合起來，我們的目標是將超濾治療擴展到美國許多患有液體超負荷且對利尿劑無反應的心臟衰竭患者。我們正在積極參與最終確定治療途徑和試驗研究地點。

At the conclusion of the pilot, DaVita has the option to deliver its ultrafiltration service approval and expand ultrafiltration services to inpatient emergency room, observation units, and outpatient facilities in their contracted hospital accounts. Once that approval is deliver, our supply and collaboration agreement would be effective for up to two 5-year terms. We believe the future success of our pilot program with DaVita could potentially accelerate the clinical adoption of ultrafiltration when first line medical treatments are ineffective, changing the revenue growth trajectory for Nuwellis with an accelerated path to profitability.

試點結束後，DaVita 可以選擇批准其超濾服務，並將超濾服務擴展到其簽約醫院帳戶中的住院急診室、觀察室和門診設施。一旦獲得批准，我們的供應和合作協議將在最多兩個 5 年期限內有效。我們相信，當第一線醫療治療無效時，我們與 DaVita 試點計畫的未來成功可能會加速超濾的臨床採用，從而改變 Nuwellis 的收入成長軌跡，加速獲利。

I would like now to turn the call over to our Chief Medical Officer, Dr. John Jefferies, who would provide additional color on our DaVita collaboration and our clinical programs, in addition to his perspective on recent news affecting the renal industry. Dr. Jefferies?

我現在想將電話轉給我們的首席醫療官 John Jefferies 博士，除了他對影響腎臟行業的最新新聞的看法外，他還將就我們的 DaVita 合作和臨床項目提供更多資訊。傑弗里斯博士？

Thank you, Nestor, and good morning, everyone. I'd like to cover three topics with you today.

謝謝你，內斯特，大家早安。今天我想和大家談三個話題。

First, our collaboration with DaVita, as you heard alluded to. Second, the progress we are making with our reverse clinical trial. And then third, our thoughts on ongoing announcements regarding the impact of a certain class of weight loss drugs or the so called GLP-1 agonists in renal care and our business.

首先，正如您所提到的，我們與 DaVita 的合作。其次，我們在反向臨床試驗方面所取得的進展。第三，我們對某類減肥藥或所謂的 GLP-1 激動劑對腎臟護理和我們業務的影響的持續公告的看法。

So for us it's encouraging to note that our collaboration with DaVita continues to leverage expertise from cardiovascular medicine and nephrology, which provides a powerful vehicle to enhance our understanding of the cardio-renal syndrome. As such, we continue to look forward to increased awareness of the growing number of heart failure patients in United States and improve recognition of ultrafiltration as a safe and effective therapeutic option. Whereas treatment of fluid overload continues to center on the use of oral and intravenous diuretics therapies, Aquadex offers a more predictable and precise approach to treatment of this very difficult clinical condition.

因此，對我們來說，令人鼓舞的是，我們與 DaVita 的合作繼續利用心血管醫學和腎臟病學的專業知識，這為增強我們對心腎綜合徵的理解提供了強大的工具。因此，我們繼續期待提高對美國日益增多的心臟衰竭患者的認識，並提高對超濾作為安全有效的治療選擇的認識。雖然液體超負荷的治療仍然集中在使用口服和靜脈注射利尿劑療法，但 Aquadex 提供了一種更可預測和更精確的方法來治療這種非常困難的臨床病症。

Building on our body of clinical evidence, we continue to make progress on our Reverse-HF trial, evaluating mortality and heart failure events within 30 and 90 days of hospital discharge. To date, we now have 15 sites activated and a sevenfold increase in the number of enrolled patients since Q4 2022. As it relates to weight loss drugs, GLP-1 receptor agonists are increasingly prescribed in the US and internationally.

基於我們的臨床證據，我們繼續在 Reverse-HF 試驗上取得進展，評估出院 30 和 90 天內的死亡率和心臟衰竭事件。迄今為止，我們已激活15 個中心，自2022 年第四季度以來入組患者數量增加了七倍。由於與減肥藥物相關，GLP-1 受體激動劑在美國和國際上越來越多地開出處方。

These drugs are known to help regulate blood sugar levels. There are reports that GLP-1 receptor agonists may also reduce the risk of heart failure and other cardiovascular events in patients with type two diabetes. There's also evidence that these drugs may improve symptoms of heart failure. However, these reports are relatively small and long-term benefits in these areas are yet to be determined. And therefore, it is currently unclear how the GLP-1 receptor agonists will impact the use of ultrafiltration.

眾所周知，這些藥物有助於調節血糖水平。有報告指出，GLP-1受體激動劑也可能降低第二型糖尿病患者發生心臟衰竭和其他心血管事件的風險。也有證據顯示這些藥物可以改善心臟衰竭的症狀。然而，這些報告相對較小，這些領域的長期效益仍有待確定。因此，目前尚不清楚 GLP-1 受體激動劑將如何影響超濾的使用。

Given the increasing number of heart failure patients around the globe, there will likely still be a strong need for fluid removal in these patients, some of which will benefit from mechanical diuresis as opposed to drug based interventions. In addition, this class of drugs may have the potential to bend the curve across multiple phenotypes. Which means that there may be different rates of progression to advanced heart failure and other diseases such as end-stage renal disease. It may mean that more people will ultimately benefit from additional therapeutic options, such as Aquadex.

鑑於全球心臟衰竭患者數量不斷增加，這些患者可能仍然強烈需要排出液體，其中一些患者將受益於機械利尿而不是基於藥物的干預措施。此外，這類藥物可能有可能改變多種表型的曲線。這意味著晚期心臟衰竭和終末期腎病等其他疾病的進展率可能不同。這可能意味著更多的人最終將受益於額外的治療選擇，例如 Aquadex。

For example, instead of going to a mechanical device, such as a left ventricular assist device or a heart transplant, patients may continue to be treated with guideline directed medical therapy and experience heart failure exacerbations. Which presents an opportunity for us to deliver ultrafiltration therapy to improve volume status in these acute and chronic settings.

例如，患者可能會繼續接受指南指導的藥物治療並經歷心臟衰竭惡化，而不是使用左心室輔助裝置或心臟移植等機械裝置。這為我們提供了一個機會，可以提供超濾治療，以改善這些急性和慢性環境中的容量狀態。

Thank you, and I'll turn it back over to Nestor.

謝謝你，我會把它轉回給內斯特。

Thank you, Dr. Jefferies. With that, let me now turn the call over to Rob to discuss our Q3 financial results. Rob?

謝謝你，杰弗里斯博士。現在，讓我將電話轉給 Rob，討論我們第三季的財務表現。搶？

Thank you, Nestor, and good morning, everyone.

謝謝你，內斯特，大家早安。

Revenue for the third quarter of 2023 was $2.4 million, representing a 16% increase for the second quarter of this year and a 17% increase versus the third quarter of 2022. By customer category, third quarter 2023 revenue in heart failure increased approximately 27% over the same period last year, in critical care and pediatrics increased 16% and 9%, respectively. We are pleased to highlight that despite hospital capital budget constraints, console sales increases led heart failure category growth by increases in utilization of the Aquadex systems for critical care and pediatric performance.

2023年第三季營收為240萬美元，較今年第二季成長16%，較2022年第三季成長17%。依客戶類別劃分，2023年第三季心臟衰竭營收成長約27%與去年同期相比，重症監護和兒科分別增加了16%和9%。我們很高興地強調，儘管醫院資本預算有限，但控制台銷量的增長導致了心臟衰竭類別的增長，因為 Aquadex 系統在重症監護和兒科表現方面的利用率有所提高。

Gross margin was 57.3% for the third quarter of 2023, compared to 61% in the prior year period. The decline in gross margin was primarily driven by lower console manufacturing volumes. However, our US disposable product margins are 74%, which are in-line with medical technology industry standards. Selling, general and administrative expenses in the third quarter were $3.4 million, a decrease of approximately $800,000, compared to the prior year quarter, driven by reduced headcount and related compensation expense.

2023 年第三季的毛利率為 57.3%，去年同期為 61%。毛利率下降主要是因為遊戲機產量下降所致。然而，我們的美國一次性產品利潤率為 74%，符合醫療科技產業標準。第三季的銷售、一般和管理費用為 340 萬美元，與去年同期相比減少了約 80 萬美元，因為員工人數和相關薪酬費用減少。

Third quarter research and development expense was $1.1 million, an increase of approximately $200,000, compared to third quarter of 2022, reflecting a modest increase in spend related to the final phases of development of our new pediatric CRRT device as we approach IDE submission. Total operating expenses were $4.5 million in the quarter, a decrease of approximately 12% compared to the third quarter of 2022 and a decrease of 26% sequentially. Both the year-over-year and sequential decreases were due to cost saving measures implemented early in Q3.

第三季的研發費用為110 萬美元，與2022 年第三季相比增加了約20 萬美元，反映出隨著我們接近IDE 提交，與我們的新型兒科CRRT 設備開發的最後階段相關的支出略有增加。本季總營運費用為 450 萬美元，較 2022 年第三季下降約 12%，比上一季下降 26%。年比和季減都是由於第三季初期實施的成本節約措施。

Net loss in the third quarter was $3.4 million, or a loss of $1.81 per common share, compared to a net loss of $3.9 million, or $36.72 per common share in the prior year period. The year-over-year decrease in the net loss per share is driven by an increase in sales, lower spend, and an increase in weighted average share count. We ended the third quarter with no debt and $4.9 million in cash and cash equivalents on the balance sheet, and we had 1.9 million common shares outstanding at September 30. On October 17, we closed $2.25 million of gross proceeds before deducting underwriting discounts and commissions and a public offering of Series J Convertible Redeemable Preferred Stock and Warrants.

第三季淨虧損為 340 萬美元，即每股普通股虧損 1.81 美元，去年同期淨虧損為 390 萬美元，即每股普通股虧損 36.72 美元。每股淨虧損年減的原因是銷售額增加、支出減少、加權平均股數增加。截至第三季末，我們的資產負債表上沒有債務，現金和現金等價物為490 萬美元，截至9 月30 日，我們有190 萬股已發行普通股。10 月17 日，我們在扣除承銷折扣和佣金之前結清了225 萬美元的總收益J 系列可轉換可贖回優先股和認股權證的公開發行。

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

我們準備好的演講到此結束。接線員，我們現在要開始提問。

(Operator Instructions) Aaron Wukmir, Lake Street Capital.

（操作員說明）Aaron Wukmir，Lake Street Capital。

Hey, good morning, guys, this is Aaron on the line for Brooks this morning. I guess I want to start with sort of your expectation regarding the partnership with DaVita as it sort of relates to what you see them contributing to their -- your success and the financial arrangement you have with them. And I know you mentioned a little bit in the prepared remarks, but I'm just trying to get a bit more color on what we can sort of expect with that aspect going forward here.

嘿，早上好，夥計們，我是亞倫，今天早上接聽了布魯克斯的電話。我想我想先談談您對與 DaVita 合作的期望，因為這與您看到他們為您的成功做出的貢獻以及您與他們的財務安排有關。我知道你在準備好的發言中提到了一點，但我只是想進一步了解我們在這方面的進展可以期待什麼。

Yes, good morning, Aaron. Good question. As you know, DaVita provides both ambulatory dialysis service, as well as inpatient dialysis for patients that are hospitalized needing dialysis. And they have a team of nurses and medical staff to provide that dialysis in the inpatient, in their what they call the DaVita multi treatment rooms. So the idea is for patients needing ultrafiltration, they have contract with DaVita for the dialysis is to do their ultrafiltration in their rooms.

是的，早上好，亞倫。好問題。如您所知，DaVita 既提供門診透析服務，也為需要透析的住院患者提供住院透析服務。他們擁有一支由護士和醫務人員組成的團隊，在他們所謂的 DaVita 多功能治療室中為住院病人提供透析服務。因此，我們的想法是，對於需要超濾的患者，他們與 DaVita 簽訂了透析合同，即在他們的房間內進行超濾。

Now when you look at their public documents that they have published, you see that they have a large number of contract hospitals doing the dialysis. So the idea with this collaboration and supply is for us to sell the product to DaVita and they will provide the services to the hospitals to do ultrafiltration in fluid overload patients.

現在你看他們公佈的公開文件，你會發現他們有大量的簽約醫院在做透析。因此，這次合作和供應的想法是我們將產品出售給 DaVita，他們將為醫院提供服務，對液體超負荷患者進行超濾。

(technical difficulty) Did I answer your question, Aaron?

（技術難度）我回答你的問題了嗎，亞倫？

Yeah, yeah. And then I guess sort of the same question in reference with SeaStar. How that different -- or how that differ materially, I guess?

是啊是啊。然後我猜想與 SeaStar 也有同樣的問題。我猜這有什麼不同——或者說有什麼實質的不同？

Well, their device for pediatric use, we have an exclusive license and distribution agreement with them. Patients -- pediatric patients needing to come into the hospital with a (technical difficulty) inflammatory reaction can be treated with the SeaStar device and significantly improve their mortality, as well as their quality of life. So the idea is for us, for our organization -- our field organization to distribute that product in the pediatric hospitals, especially the ones where we have also ultrafiltration business.

嗯，他們的兒科設備，我們與他們有獨家許可和分銷協議。患者－因（技術困難）發炎反應而需要入院的兒科患者可以使用 SeaStar 設備進行治療，並顯著提高他們的死亡率和生活品質。因此，我們的想法是為我們的組織—我們的現場組織在兒科醫院分銷該產品，特別是我們也有超濾業務的醫院。

Got you. Okay, and then if I could ask just one quick follow-up. Obviously, there is a fairly significant reduction to operating expenses this quarter. You sort of mentioned that they were due to some cost-saving measures. Is this sort of the plan moving forward to continue to make these cuts to OpEx? Or do you sort of see a different path to sort of achieving your longer-term goals?

明白你了。好的，然後我可以問一個快速的後續問題嗎？顯然，本季的營運費用有相當大的減少。您提到這是由於採取了一些節省成本的措施。這種計劃是否會繼續削減營運支出？或者您看到了實現長期目標的不同途徑？

Thanks for taking the questions.

感謝您提出問題。

Yes. On the last question, we did some savings measures in Q3 because we needed to rightsize and also provide more runway to our cash. So we don't expect to do anything more in the future -- anything drastic in the future. But we will continue to find ways to be more effective and efficient both in the field as well as here in our headquarters with our product margins.

是的。關於最後一個問題，我們在第三季採取了一些節省措施，因為我們需要調整規模並為我們的現金提供更多跑道。因此，我們預計未來不會再做任何事情——任何激烈的事情。但我們將繼續尋找方法，使我們的產品利潤在現場和總部中更加有效和有效率。

Got you. That's very helpful. Thank you, guys.

明白你了。這非常有幫助。感謝你們。

Thank you. Aaron

謝謝。亞倫

Anthony Vendetti, Maxim Group.

安東尼文代蒂，馬克西姆集團。

Thanks. Good morning, guys. (multiple speakers) I'm just a little bit more of a follow-up on DaVita. So, I know it's a pilot phase, but can you talk a little bit about what the plan is for the rollout, how many centers. And during this pilot phase, do you expect there to be a contribution to sales either in this quarter at all? Or is it more of a 2024 situation?

謝謝。早上好傢伙。 （多個發言者）我只是 DaVita 的後續行動。所以，我知道這是一個試點階段，但你能談談推出的計畫是什麼，有多少個中心。在這個試點階段，您預計本季會對銷售有所貢獻嗎？或者這更像是 2024 年的情況？

Yes. yeah, good question, Anthony. Just to be clear, this collaboration that we were doing with DaVita is new to every stakeholder in this treatment. I mean, is new to DaVita, is new to us, and is new to the hospitals. So we decided to do a pilot just to learn everything that we need to learn about this collaboration, which includes treatment pathways for patients, billing, a contract amendment that DaVita would have to do with their hospital customers.

是的。是的，好問題，安東尼。需要明確的是，我們與 DaVita 的合作對於該治療的每個利益相關者來說都是新鮮的。我的意思是，這對 DaVita 來說是新的，對我們來說是新的，對醫院來說也是新的。因此，我們決定進行一項試點，以了解我們需要了解的有關此次合作的一切信息，其中包括患者的治療途徑、計費、DaVita 必須與醫院客戶進行的合約修訂。

So we wanted to take the time to make sure that everything goes well, both for the hospitals as well as for DaVita and for us. So that's why we're initiating this pilot. And we are in the process of defining the care pathway, what are the sites that are more fitted to do this collaboration?

因此，我們想花時間確保一切順利，無論是對醫院、DaVita 還是我們都是如此。這就是我們啟動該試點的原因。我們正在定義護理途徑，哪些網站更適合進行這種合作？

So we having a lot of good results, a lot of good acceptance by hospitals that are contracted by DaVita, but they want to do ultrafiltration. And for reasons they have capital budget issues or nursing staff issues. So they feel that the collaboration with Nuwellis and DaVita, will fit their needs appropriate.

因此，我們取得了很多好的成果，得到了 DaVita 簽約醫院的良好認可，但他們想做超濾。由於某些原因，他們存在資本預算問題或護理人員問題。因此他們認為與 Nuwellis 和 DaVita 的合作將適合他們的需求。

(multiple speakers) second part of your question about the impact in Q2, well the idea is that DaVita would buy the consoles and the circuits, as we start treating patients in the hospitals.

（多個發言者）關於第二季度影響的問題的第二部分，我們的想法是，當我們開始在醫院治療患者時，DaVita 將購買控制台和電路。

Okay, so they'll start actually purchasing them. You mentioned a contract -- contract amendment, Nestor. Does DaVita has a certain contract with their customers?

好的，他們會開始實際購買它們。你提到了一份合約——合約修正案，內斯特。 DaVita 是否與其客戶簽訂了特定合約？

And the amendment to add in ultrafiltration, is that just a small amendment that they add in? What would that look like? Did they have to agree to purchase? Could they rent? Is there a lot of flexibility there? Or are you attempting to standardize it with DaVita and their customers?

還有超濾的修改，只是他們加的一​​個小修改嗎？那會是什麼樣子呢？他們必須同意購買嗎？他們可以出租嗎？那裡有很大的靈活性嗎？或者您正在嘗試與 DaVita 及其客戶一起將其標準化？

Yeah. Good question, Anthony. The answer to those questions is what we plan to obtain with this pilot. So right now, DaVita has contracted hospitals to do dialysis, so they would have to amend those contracts to do ultrafiltration.

是的。問得好，安東尼。這些問題的答案就是我們計劃透過該試點獲得的答案。所以現在，達維塔已經與醫院簽訂了透析合同，因此他們必須修改這些合約才能進行超濾。

DaVita will buy the product from us, and they will provide the services to their patients with their own clinical staff. So what I assume is and what we are all assuming, is that the hospital would pay a per patient fee to DaVita for treating those patients for ultrafiltration. But DaVita will take care of the rest.

DaVita 將從我們這裡購買產品，他們將與自己的臨床人員一起為患者提供服務。因此，我的假設以及我們所有人的假設是，醫院將向 DaVita 支付每位患者的費用，用於治療這些患者的超濾。但達維塔會處理剩下的事情。

Okay, great. That's very helpful.

好的，太好了。這非常有幫助。

Yeah. And that's the benefit for the hospital. Hospitals that are having some capital budgets or nursing staff, this is a viable way for them to treat ultrafiltration patients.

是的。這就是醫院的好處。對於有一定資本預算或護理人員的醫院來說，這是治療超濾患者的可行方法。

And then a follow-up on the difference between that and maybe SeaStar's SCD device for pediatrics.

然後跟進該設備與 SeaStar 的兒科 SCD 設備之間的差異。

So is that a similar situation where you purchased from SeaStar, and then you sell that device either -- what your ultrafiltration device for separately, depending on what the customer's looking for?

那麼，這是否與您從 SeaStar 購買，然後出售該設備的情況類似 - 您的超濾設備分別用於什麼，取決於客戶的需求？

Correct. We would purchase the product from SeaStar and then we will sell it to the customers with our ultrafiltration services. But let me just say -- clarify something here too. Our new pediatric dedicated device would be a CRRT device. That's the device that would be a pair with SeaStar's device right now.

正確的。我們會從 SeaStar 購買產品，然後透過我們的超濾服務將其出售給客戶。但我只想說——這裡也澄清一些事情。我們新的兒科專用設備將是 CRRT 設備。該設備目前將與 SeaStar 的裝置配對。

Right now, when we start selling the SeaStar device, that would be to use with their own CRRT devices that the hospitals would already have.

現在，當我們開始銷售 SeaStar 設備時，這將與醫院現有的 CRRT 設備一起使用。

I see. So your new continual replacement immunotherapy device is what you'll pair with the SCD device. But right now, until that device is available, the hospitals are using whatever device they have for CRRT.

我懂了。因此，您的新的持續更換免疫治療設備將與 SCD 設備配對。但目前，在該設備可用之前，醫院正在使用現有的任何設備進行 CRRT。

Correct. Right now, in the market there is only adult CRRT devices being used in these pediatric patients. So the SeaStar device will be used with any CRRT device currently used to treat this patient, but they all adult. When we introduce our pediatric dedicated CRRT device together with the SeaStar device, will be a much better therapy for these patients. This is why we believe, as well as many pediatric nephrologists that this is going to change the game.

正確的。目前，市場上只有成人 CRRT 設備用於這些兒科患者。因此，SeaStar 設備將與目前用於治療該患者的任何 CRRT 設備一起使用，但他們都是成年人。當我們將兒科專用 CRRT 設備與 SeaStar 設備一起推出時，將為這些患者提供更好的治療方法。這就是為什麼我們以及許多兒科腎病專家相信這將改變遊戲規則。

Game changer yeah, sounds like a good partnership.

是的，遊戲規則改變者，聽起來是一個很好的合作關係。

Correct.

正確的。

I just wanted to say, you mentioned two -- did you mention two to three new products? This being one of them. Were there others that you could talk about or not at this time?

我只是想說，你提到了兩個——你提到了兩到三個新產品嗎？這就是其中之一。此時您還有其他可以談論或不可以談論的嗎？

Yes. Good observation, Anthony. We have three new products that we are going to be introducing in the next two years. Starting with the SeaStar device, that's one. We also introducing very soon an additional catheter -- venous catheter to be used with our Aquadex system. And then mid-2025, we plan to commercialize the pediatric dedicated CRRT device. So those are the three devices in the next two years.

是的。觀察力很好，安東尼。我們將在未來兩年內推出三款新產品。從 SeaStar 設備開始，這就是其中之一。我們很快也會推出額外的導管——與我們的 Aquadex 系統一起使用的靜脈導管。然後，我們計劃在 2025 年中期將兒科專用 CRRT 設備商業化。這就是未來兩年的三款設備。

Great. Okay, thank you very much. Appreciate it. I'll hop back in queue.

偉大的。好的，非常感謝。欣賞它。我會跳回隊列。

Thank you.

謝謝。

Seeing that there are no further questions. I would like to turn the conference back over to Nestor Jaramillo for closing remarks.

看到沒有其他問題了。我想將會議轉回由內斯特·哈拉米洛（Nestor Jaramillo）致閉幕詞。

Thank you, operator. We are deeply encouraged by our progress across multiple initiatives, including organic growth in our core business. We believe the success of our DaVita pilot program will lead to ultrafiltration service approval, expanding ultrafiltration therapy, and meaningfully accelerate our revenue growth and path to profitability. To this, we add new product opportunities in our high growth pediatric category with the SeaStar SCD device targeted for marketing approval for commercialization by year end 2023 or early 2024, depending on the [HDE] approval.

謝謝你，接線生。我們對多項措施的進展深感鼓舞，包括核心業務的有機成長。我們相信，DaVita 試點計畫的成功將帶來超濾服務的批准，擴大超濾治療，並有意義地加速我們的收入成長和獲利之路。為此，我們在高成長的兒科類別中增加了新的產品機會，SeaStar SCD 設備的目標是在 2023 年底或 2024 年初獲得商業化的營銷批准，具體取決於 [HDE] 的批准。

Finally, we with increased awareness of our body of clinical and economic evidence. We are continued to advance market penetration in our ultrafiltration therapy with healthy growth in therapy utilization, in our heart failure, critical care, and pediatric categories. As we conclude our call, I would like to thank all our stakeholders as well as employees, stockholders, physician, nurses, patients, and health care workers in the field. We have a full and exciting lineup of opportunities ahead and appreciate your continued support as we drive meaningful progress in our initiatives to transform the lives of patients suffering from fluid overload with our Aquadex system ultrafiltration therapy. Thank you.

最後，我們對臨床和經濟證據的認識不斷提高。我們將繼續提高超濾治療的市場滲透率，並在心臟衰竭、重症監護和兒科類別中實現治療利用率的健康成長。在我們結束電話會議時，我要感謝所有利害關係人以及該領域的員工、股東、醫生、護士、病人和醫護人員。我們面臨著一系列令人興奮的機會，感謝您的持續支持，我們將透過我們的 Aquadex 系統超濾療法推動我們的舉措取得有意義的進展，以改變患有液體超負荷的患者的生活。謝謝。

The conference has now concluded. Thank you for attending today's presentation. You may now disconnect.

會議現已結束。感謝您參加今天的演講。您現在可以斷開連線。