CorMedix Inc (CRMD) 2025 Q1 法說會逐字稿

Good day, and welcome to the CorMedix Inc. first-quarter 2025 financial results conference call. (Operator Instructions) Please note this event is being recorded. I would now like to turn the conference over to Dan Ferry, LifeSci Advisors. Please go ahead.

大家好，歡迎參加 CorMedix Inc. 2025 年第一季財務業績電話會議。（操作員指示）請注意，此事件正在被記錄。現在我想將會議交給 LifeSci Advisors 的 Dan Ferry。請繼續。

Good morning and welcome to the CorMedix first-quarter 2025 earnings conference call. Leading the call today is Joe Todisco, Chief Executive Officer of CorMedix. He's joined by Doctor Matt David, Executive Vice President and CFO. That's Zelnick Kaufman, EVP and Chief Legal and Compliance Officer; Liz Hurlburt, EVP and Chief Clinical Strategy and Operations Officer; and Erin Mistry, EVP and Chief Commercial Officer.

早安，歡迎參加 CorMedix 2025 年第一季財報電話會議。今天主持電話會議的是 CorMedix 執行長 Joe Todisco。和他一起出席的還有執行副總裁兼財務長馬特戴維博士 (Dr. Matt David)。那是執行副總裁兼首席法律與合規官 Zelnick Kaufman； Liz Hurlburt，執行副總裁兼首席臨床策略和營運長；以及執行副總裁兼首席商務官 Erin Mistry。

Before we begin, I would like to remind everyone that during the call, management may make what are known as forward-looking statements within the meeting set forth in the Private Securities Litigation Reform Act of 1995. These statements are statements other than statements of historical fact regarding management's expectations, beliefs, goals, and plans about the company's prospects and future financial position.

在我們開始之前，我想提醒大家，在電話會議期間，管理階層可能會在 1995 年《私人證券訴訟改革法案》規定的會議中做出所謂的前瞻性聲明。這些陳述不是關於管理層對公司前景和未來財務狀況的期望、信念、目標和計劃的歷史事實陳述。

Actual results may differ materially from the estimates and projections on which these statements are based due to a variety of important factors, including the risk and uncertainties described in greater detail in CorMedix's filings with the SEC, which are available free of charge at the SEC's website or upon request from CorMedix.

由於各種重要因素，包括 CorMedix 向美國證券交易委員會 (SEC) 提交的文件中更詳細描述的風險和不確定性，實際結果可能與這些聲明所依據的估計和預測存在重大差異，這些文件可在 SEC 網站上免費獲取，也可根據 CorMedix 的要求獲取。

CorMedix may not actually achieve the goals or plans described in these forward-looking statements, and investors should not place undue reliance on these statements. CorMedix does not intend to update these forward-looking statements except as required by law.

CorMedix 可能無法真正實現這些前瞻性聲明中所描述的目標或計劃，投資者不應過度依賴這些聲明。除非法律要求，否則 CorMedix 不打算更新這些前瞻性聲明。

During this call, the company will discuss certain non-GAAP measures of its performance. GAAP to non-GAAP financial reconciliations and supplemental financial information are provided in CorMedix's earnings release and the current report on Form 8-K filed with the SEC. This information is available on the Investor Relations section of CorMedix's website.

在本次電話會議中，本公司將討論其績效的某些非公認會計準則衡量指標。CorMedix 的收益報告和向美國證券交易委員會提交的 8-K 表格當前報告中提供了 GAAP 與非 GAAP 財務對帳和補充財務資訊。此資訊可在 CorMedix 網站的投資者關係部分找到。

At this time, it's now my pleasure to turn the call over to Joe Todisco, Chief Executive Officer of CorMedix. Joe, please go ahead.

現在，我很高興將電話轉給 CorMedix 執行長喬·托迪斯科 (Joe Todisco)。喬，請繼續。

Thanks, Dan. Good morning, everyone, and thank you for joining us on this call. CorMedix continues to have solid momentum with the launch of DefenCath, highlighted by strong first quarter net sales of $39.1 million in line with our earlier pre-announced results. Adjusted EBITDA for the first quarter of $23.6 million was slightly above our earlier pre-announcement.

謝謝，丹。大家早安，感謝大家參加這次電話會議。CorMedix 隨著 DefenCath 的推出繼續保持強勁發展勢頭，第一季淨銷售額強勁，達到 3,910 萬美元，與我們先前公佈的業績一致。第一季調整後的 EBITDA 為 2,360 萬美元，略高於我們先前的預公告。

We continue to see steady utilization growth with existing anchor customer US Renal Care. IRC and DCI, as well as new utilization with smaller outpatient dialysis operators and inpatient hospitals and health systems.

我們繼續看到現有主要客戶 US Renal Care 的利用率穩定成長。IRC 和 DCI，以及小型門診透析業者和住院醫院和衛生系統的新利用。

For the month of April, as an example, inpatient hospital ordering accounted for more than 6% of shipments, up more than double from the first quarter. In early April, we updated our net revenue guidance for DefenCath sales to existing customers for the first half of the year, and we guided to a range of $62 million to $70 million, which implied second quarter 2025 net revenue guidance of $23 million to $31 million based upon first quarter results. I'm happy to say that based on order trends and inventory tracking, we're able to further narrow our guidance to the upper end of that range and currently project net revenue of approximately $70 million from existing purchasing customers over the first half of the year.

以4月為例，住院醫院的訂單佔出貨量的6%以上，比第一季增加了一倍以上。4 月初，我們更新了上半年 DefenCath 向現有客戶銷售的淨收入指引，指引範圍為 6,200 萬美元至 7,000 萬美元，這意味著根據第一季業績，2025 年第二季的淨收入指引為 2,300 萬美元至 3,100 萬美元。我很高興地說，根據訂單趨勢和庫存跟踪，我們能夠進一步將我們的指導範圍縮小到該範圍的上限，目前預計今年上半年來自現有購買客戶的淨收入約為 7000 萬美元。

As we stated on our previous call, the moderate sequential decline in revenue anticipated between Q1 and Q2 of this year is largely due to the timing of shipments to US Renal Care, in which they purchased a few additional weeks of inventory in both the fourth quarter of 2024 and first quarter of 2025, respectively. We expect that beginning in the third quarter of this year for order volumes from US Renal Care to normalize and more closely track patient utilization.

正如我們在上次電話會議上所述，預計今年第一季和第二季收入將出現溫和的環比下降，這主要是由於向 US Renal Care 發貨的時間安排所致，他們分別在 2024 年第四季度和 2025 年第一季度額外購買了幾週的庫存。我們預計，從今年第三季開始，美國腎臟護理中心的訂單量將恢復正常，並更緊密地追蹤患者的使用率。

To that extent, we do anticipate utilization growth in the back half of 2025 as new patients initiate therapy at existing customers and as we add new customers in both the inpatient and outpatient settings. A large variable for our potential full year financial outlook is the timing and scale of uptake by our previously announced large dialysis operator customer.

從這個意義上講，隨著新患者在現有客戶處開始治療以及我們在住院和門診環境中增加新客戶，我們確實預計 2025 年下半年利用率會成長。我們全年財務前景的一個重大變數是我們先前宣布的大型透析營運商客戶的採用時間和規模。

Over the last few weeks, we have seen increased levels of communication and planning related activities with medical and operations staff at the customer, and to that extent, we are optimistic of achieving our target for a mid-year 2025 implementation start. We intend to update investors once we have more definitive timeline from the customer.

在過去的幾周里，我們看到與客戶的醫療和營運人員的溝通和規劃相關活動的水平有所提高，從這個意義上講，我們對實現 2025 年中期開始實施的目標充滿信心。一旦我們從客戶那裡獲得更明確的時間表，我們打算立即向投資者通報最新情況。

Turning back to the inpatient market, our dedicated inpatient sales team is now fully staffed, trained, and operational in the field, and we are hopeful to increase penetration as we move throughout 2025. Our partnership with WSI for promotion to federal facilities is also fully operational, and we received and shipped our first orders to VA facilities in the first quarter.

回到住院市場，我們專門的住院銷售團隊現已配備齊全的人員、經過培訓並可在該領域開展工作，我們希望在 2025 年提高滲透率。我們與 WSI 合作向聯邦設施進行推廣的合作關係也已全面啟動，我們在第一季收到並向 VA 設施發送了第一批訂單。

Focusing now on our clinical developments, we've begun our Phase 3 clinical study for the reduction of central line-associated blood stream infections, or CLABSIs, in adult patients receiving Total Parenteral Nutrition, or TPN, through a central venous catheter. Site selection began in February, and I'm happy to report that our first site is operational and actively screening patients, and we expect our first patient to be dosed over the next few days.

現在我們專注於臨床開發，已開始進行第 3 階段臨床研究，旨在減少透過中心靜脈導管接受全腸外營養 (TPN) 的成年患者的中心靜脈導管相關血流感染 (CLABSI)。選址工作於二月開始，我很高興地報告，我們的第一個選址已經投入運營並正在積極篩檢患者，我們預計我們的第一位患者將在未來幾天內接受給藥。

As a reminder, this is a 12-month study in less than 150 patients, and we are targeting completion of the study and submission of a new drug application to FDA by the end of 2026 or beginning of 2027. We recently submitted to FDA an application for orphan drug status for this indication and are awaiting FDA's determination of eligibility.

提醒一下，這是一項針對不到 150 名患者進行的為期 12 個月的研究，我們的目標是在 2026 年底或 2027 年初完成研究並向 FDA 提交新藥申請。我們最近向 FDA 提交了針對該適應症的孤兒藥地位申請，正在等待 FDA 的資格認定。

The company's goal for TPN is to obtain FDA approval for an expanded use of our taurolidine and heparin catheter lock solution in the late 2027 to early 2028 time frame. And we estimate annual peak sales potential in this indication to be in the range of $150 million to $200 million based off a total addressable market size of $500 million to $750 million. We will provide investors with updates on progress in this important area of unmet need as we move forward.

該公司的 TPN 目標是在 2027 年底至 2028 年初獲得 FDA 批准擴大使用我們的牛磺羅定和肝素導管鎖定溶液。我們估計，基於 5 億至 7.5 億美元的總目標市場規模，該適應症的年峰值銷售潛力在 1.5 億至 2 億美元之間。我們將在未來向投資者提供這一重要未滿足需求領域的最新進展。

Our other clinical initiatives also continue to make solid progress. Our real-world evidence study that is being run in cooperation with our study partner, US Renal Care, has eclipsed 2000 patients and will hit its midpoint in July. Our hope with this study in which we expect to evaluate patient outcomes over a 24-month period, is to generate real-world evidence around the impact of DefenCath utilization on the cost of patient care, infection rates, hospitalizations, mortality, and multiple other metrics such as lost share time and CRBSI-related antibiotic use. Data from this study will be critical to our objective of making DefenCath the standard of care catheter to lock in the outpatient hemodialysis setting.

我們的其他臨床計劃也持續取得穩定進展。我們與研究夥伴 US Renal Care 合作進行的真實世界證據研究已超過 2000 名患者，並將於 7 月達到中點。我們希望透過這項研究來評估 24 個月內患者的結果，從而產生關於 DefenCath 使用對患者護理成本、感染率、住院率、死亡率以及其他多項指標（如共享時間損失和 CRBSI 相關抗生素使用）的影響的真實證據。這項研究的數據對於我們實現使 DefenCath 成為門診血液透析環境中的護理導管標準至關重要。

In addition to our adult TPN and real-world evidence studies, our study of DefenCath in the pediatric hemodialysis population is on target to begin in the third quarter of this year. And our expanded access program for high-risk populations, including but not limited to pediatric TPN, peritoneal dialysis patients with refractory peritonitis, and neutropenic oncology patients utilizing a CBC, is now live.

除了我們的成人 TPN 和真實世界證據研究之外，我們針對兒科血液透析族群的 DefenCath 研究也計劃於今年第三季開始。我們針對高風險族群的擴展獲取計畫現已上線，包括但不限於兒科 TPN、患有難治性腹膜炎的腹膜透析患者以及使用 CBC 的中性粒細胞減少性腫瘤患者。

I would now like to turn the call over to Matt to discuss the company's first quarter financial results and financial position. Matt.

現在我想把電話轉給馬特，討論公司第一季的財務表現和財務狀況。馬特。

Thanks, Joe, and good morning, everyone. I am pleased to be here today to provide an overview of our first-quarter 2025 financial results, as well as an update on CorMedix's cash position.

謝謝，喬，大家早安。我很高興今天能在這裡概述我們的 2025 年第一季財務業績，以及 CorMedix 現金狀況的最新情況。

The company has filed its quarterly report on Form 10-Q for the quarter ended March 31, 2025. I urge you to read the information contained in the report for a more complete discussion of our financial results.

該公司已提交截至 2025 年 3 月 31 日的 10-Q 表格季度報告。我建議您閱讀報告中包含的信息，以便更全面地討論我們的財務結果。

With respect to our first quarter of 2025 financial results, our net revenue for the first quarter of 2025 amounted to $39.1 million. CorMedix achieved profitability for the first quarter as our net income was $20.6 million or $0.32 per share compared with the net loss of $14.5 million or $0.25 per share in the first quarter of 2024. The net income recognized in 2025 was driven by the gross profits associated with the net sales of DefenCath.

關於我們 2025 年第一季的財務業績，我們 2025 年第一季的淨收入為 3,910 萬美元。CorMedix 第一季獲利，淨收入為 2,060 萬美元，即每股 0.32 美元，而 2024 年第一季的淨虧損為 1,450 萬美元，即每股 0.25 美元。2025 年確認的淨收入來自與 DefenCath 淨銷售額相關的毛利。

Operating expenses in the first quarter of 2025 increased approximately 9% to $17.4 million compared with $15.9 million in the first quarter of 2024. R&D expense increased by approximately 281% to $3.2 million from approximately $800,000 in the first quarter of 2024, driven by the increase in personnel and clinical trial services in support of our ongoing clinical programs.

2025 年第一季的營運費用較 2024 年第一季的 1,590 萬美元增加約 9%，達到 1,740 萬美元。研發費用從 2024 年第一季的約 80 萬美元增加約 281% 至 320 萬美元，這得益於我們正在進行的臨床計畫的人員和臨床試驗服務的增加。

Selling and marketing expense decreased 29% to $4.5 million in the first quarter of 2025 compared with $6.3 million in the first quarter of 2024. G&A expense increased 11% to $9.7 million in the first quarter of 2025, versus $8.7 million in the first quarter of 2024.

2025 年第一季的銷售和行銷費用為 450 萬美元，而 2024 年第一季為 630 萬美元，下降 29%。2025 年第一季度，一般及行政費用 (G&A) 成長 11%，達到 970 萬美元，而 2024 年第一季為 870 萬美元。

The decrease in selling and marketing expense is considered temporary and related to the timing of our prior internal sales force versus the ramping of costs related to our outsourced salesforce. We expect those costs to be normalized for the second quarter. The increase in G&A expense was primarily driven by non-cash charges for stock-based compensation.

銷售和行銷費用的減少被認為是暫時的，並且與我們之前的內部銷售隊伍的時間安排以及與我們的外包銷售隊伍相關的成本的增加有關。我們預計這些成本將在第二季恢復正常。一般及行政費用的增加主要是由於股票薪酬的非現金費用。

We recorded net cash provided by operations during the first quarter of 2025 of $19.7 million compared with net cash used in operations of $17.3 million in the first quarter of 2024. The increase is driven by our net income for the period versus the net loss in the comparison period.

我們記錄了 2025 年第一季營運提供的淨現金為 1,970 萬美元，而 2024 年第一季營運使用的淨現金為 1,730 萬美元。這一增長是由本期淨收入與比較期淨虧損相比較而推動的。

The company has cash and cash equivalents of $77.5 million as of March 31, 2025. As described previously, we are guiding to 2025 cash operating expenses of approximately $72 million to $78 million. The increase over 2024 spending levels is expected to be largely driven by an increase in R&D spending on our clinical initiatives.

截至 2025 年 3 月 31 日，該公司的現金和現金等價物為 7,750 萬美元。如前所述，我們預計 2025 年現金營運費用約為 7,200 萬美元至 7,800 萬美元。預計 2024 年支出水準的成長將主要得益於我們臨床計畫的研發支出的增加。

I will now turn the call back over to Joe for closing remarks. Joe.

現在我將把電話轉回給喬，請他作最後發言。喬。

Thanks, Matt. CorMedix is working diligently on all fronts to increase our existing customer base as well as expanding DefenCath to new therapeutic indications. I appreciate everyone's continued support in CorMedix, and I'm happy to take questions.

謝謝，馬特。CorMedix 正在各方面努力工作，以擴大我們現有的客戶群，並將 DefenCath 擴展到新的治療適應症。我感謝大家對 CorMedix 的持續支持，並且很樂意回答問題。

(Operator Instructions) Gregory Renza, RBC Capital.

（操作員指示）Gregory Renza，RBC Capital。

Joe, maybe just starting with the LDO partnership. It sounds like at the top, you mentioned just some degree of optimism in the progress. Just curious if you could just provide how that has -- how your perceptions and your engagement there has evolved since we've last spoken in the last quarter or so?

喬，也許只是從 LDO 合作夥伴關係開始。聽起來，您在上面提到了對進展的某種程度的樂觀態度。我只是好奇，您是否可以提供一下自從我們上個季度上次交談以來，您的看法和參與度發生了怎樣的變化？

And what do you think the LDO wants to see just operationally and with respect to outcomes before perhaps opening up to that to that broader population? I know that's longer-term but just want to see how you're driving to support those goals.

在向更廣泛的人群開放之前，您認為 LDO 在營運和結果方面希望看到什麼？我知道這是一個長期目標，但我只是想看看你如何努力實現這些目標。

With regard to the size of the population, I'm not going to speak on behalf of the LDO. They haven't given us any updated guidance in terms of number of patients, right? We're still working off of prior feedback and that's what we're prepared for. But also have the ability to scale up quite quickly, should we need to.

關於人口規模，我不會代表 LDO 發言。他們沒有給我們任何有關患者人數的最新指導，對嗎？我們仍在根據先前的回饋開展工作，這就是我們所準備的。但如果需要的話，我們也有能力相當快速地擴大規模。

As I said in the script, over the last few weeks we've seen heightened levels of preparatory activity. The types of things that would need to be done, right, to initiate utilization. Certainly, nothing is ever set in stone, right, with customers and we're waiting for an implementation date. But as I said, we're optimistic or cautiously optimistic as you want to take it, and we're ready to go as soon as they, hopefully, pull the trigger, on a purchase order.

正如我在劇本中所說，過去幾週我們看到準備活動的水平有所提高。為了啟動利用，需要做正確的事。當然，對於客戶來說，沒有什麼是一成不變的，我們正在等待實施日期。但正如我所說的，我們對您所希望採取的措施持樂觀或謹慎樂觀的態度，並且只要他們下達採購訂單，我們就已做好準備。

Got it. And just maybe just in inventory control, obviously this is a key priority for operators and you've commented on some of that lumpiness. Maybe just some comments, Joe, on the policy and macro volatility that you know many sectors are experiencing?

知道了。也許只是在庫存控制方面，這顯然是運營商的首要任務，您已經對其中的一些不一致性發表了評論。喬，您知道許多行業正在經歷政策和宏觀波動，您能否就此發表一些評論？

How are you reacting to that? Is there anything that you think is unpredictable or could be that could affect some of the usual lumpiness when it comes to selling into it and providing DefenCath to the operators?

您對此有何反應？在向營運商銷售和提供 DefenCath 時，您認為是否存在一些不可預測的因素或可能影響一些通常的不穩定性因素？

The macro level issues right now that are going on, call it, worldwide, whether it's tariff-related or other supply chain change of chains aren't really an issue for us, right? Our lumpiness was entirely right, or largely caused by just a price incentive that a customer had to move some inventory, or take a little bit of inventory earlier, right? And they're working through that inventory now, which is why we encouraged investors to look at the first half of the year as a lump sum period.

目前全球範圍內發生的宏觀問題，無論是與關稅有關還是其他供應鏈的變化，對我們來說都不是什麼問題，對嗎？我們的不平衡是完全正確的，或者很大程度上只是由於價格激勵而導致的，客戶必須轉移一些庫存，或者提前拿走一點庫存，對嗎？他們現在正在處理這些庫存，這就是為什麼我們鼓勵投資者將上半年視為一個總和期。

From an inventory prep standpoint, we've got a significant amount of active pharmaceutical ingredient on hand for both heparin and taurolidine, that should or will cover not only our current demand run rate for more than a year, but also a good amount of scale up should we need to support any increased customer demand.

從庫存準備的角度來看，我們手頭上有大量用於肝素和牛磺羅定的活性藥物成分，這些成分不僅可以滿足我們目前一年多的需求運行率，而且還可以滿足我們支持任何增加的客戶需求的大規模需求。

We've also got a good runway of finished dosage inventory manufactured. We have two finished dosage manufacturers that have been qualified by the FDA, so we have some flexibility there. So overall, inventory is really not a constraint for us or something that I would foresee causing any fluctuations in our earnings.

我們也擁有良好的成品劑量庫存製造能力。我們有兩家經過 FDA 認證的成品劑型製造商，因此我們在這方面具有一定的彈性。所以總的來說，庫存對我們來說並不是一個真正的限制因素，我預見也不會導致我們的收益有任何波動。

Got it. It makes sense. Congrats again. I'll hop back into the queue.

知道了。這是有道理的。再次恭喜。我會重新回到隊列中。

Roanna Ruiz, Leerink Partners.

Roanna Ruiz，Leerink Partners。

So a couple for me. First one, could you talk a bit more about the main drivers behind the 1Q revenue number, especially given the successful implementation. I was curious, did some of that strength come from US Renal or some of the small and medium dialysis centers? And what metrics are giving you more confidence to point to the top end of your first half guidance?

對我來說這是一對。首先，您能否詳細談談第一季營收數字背後的主要驅動因素，特別是考慮到成功實施。我很好奇，這種力量是否來自美國腎臟病中心或一些中小型透析中心？哪些指標能讓您更有信心達到上半年預期的最高值？

Look, I think we have a number in the queue exactly what percentage our customers or top customer accounts for. I do believe that US Renal, in the first quarter, was still more than 80% of shipments. So obviously, it is a large driver. They're currently our biggest anchor customer.

你看，我想我們在隊列中有一個數字，確切地表示我們的客戶或頂級客戶佔了多少百分比。我確實相信，美國腎臟病公司第一季的出貨量仍超過 80%。顯然，這是一個巨大的推動力。他們目前是我們最大的主力客戶。

But we did see good growth in the first quarter, as I said, with smaller customers, with hospitals. On the inpatient side, I think first quarter overall was around 3% of shipments, but a little bit larger percentage of dollars, right? There's a little bit better pricing in the hospital inpatient segment at this point in time.

但正如我所說，我們確實在第一季看到了良好的成長，包括小型客戶和醫院。就住院方面而言，我認為第一季整體出貨量約為 3%，但金額佔比會稍微大一些，對嗎？目前，醫院住院部分的定價稍微好一點。

When we talk about guidance and our thoughts around it being at the top end of the range. Well, we're doing a pretty good analysis now on inventory, certainly, at US Renal Care, but a couple of the other customers have begun sharing inventory reports.

當我們談論指導和我們的想法時，它處於範圍的頂端。嗯，我們現在對 US Renal Care 的庫存進行了相當好的分析，但其他一些客戶已經開始分享庫存報告。

We have a little bit of visibility now into what their weekly dispensing utilization is. So we're basically making a projection, right, of what they have on hand, what the rundown is going to be, and what we think new orders are going to be over the next couple of weeks.

我們現在對他們每週的配藥使用有了一點了解。因此，我們基本上是在對他們手頭上有多少庫存、庫存清單是什麼以及我們認為未來幾週內會有多少新訂單進行預測。

Yeah. Got it. And one last follow up for me, I was also curious thinking about the outstanding LDO, any updates there on what you're thinking about or what they might want to see to get more comfortable or just implement more using DefenCath and enter a contract, et cetera?

是的。知道了。最後一個跟進問題，我也很好奇關於未完成的 LDO，您有什麼想法或他們可能希望看到什麼以變得更加舒適或只是使用 DefenCath 實施更多並簽訂合約等？

Yeah, as I said to Greg, I'm not going to speak for them in terms of what they might or might not be looking at in terms of implementation or timing. I can only speak to the questions that we're being asked and what we're being asked to provide, essentially, are all the same things that we've provided to other customers, right, as we've ramped up toward implementation.

是的，正如我對格雷格所說的那樣，我不會代表他們談論他們在實施或時間表方面可能會或可能不會考慮的事情。我只能回答我們被問到的問題以及我們被要求提供的內容，本質上，這些都是我們向其他客戶提供的相同的東西，對吧，因為我們已經加緊實施了。

So as I get more information, I'm certainly going to update investors. But right now, as I said, I'm comfortable. We're optimistic that we're on the timelines that we've communicated previously.

因此，當我獲得更多資訊時，我肯定會向投資者更新資訊。但現在，正如我所說，我很舒服。我們樂觀地認為我們正在按照之前溝通過的時間表進行。

Got it. Thank you.

知道了。謝謝。

Les Sulewski, Truist Securities.

Les Sulewski，Truist Securities。

So Joe, perhaps maybe you can talk about US Renal, start there. You expect the order rates to normalize, I guess, maybe can you provide us a sense of what patient pool or a percent of their patient pool is on DefenCath? Are there additional cohorts that can be further implemented?

那麼喬，也許你可以談談美國腎臟病，從那裡開始。我想，您希望訂單率恢復正常，也許您能讓我們了解 DefenCath 的患者群體或患者群體的百分比是多少？是否有可以進一步實施的其他群組？

And then in regards to other customers, have they notified you on when they will start taking in shipments? And then just your ability to foresee the utilization tracking. I know you shared some insights into customers providing you some of that, but are you able to differentiate what's utilization versus inventory build-up? And then I have a follow up as well on reimbursement.

那麼對於其他客戶，他們是否已經通知您何時開始接收貨物？然後您就能夠預見利用率追蹤。我知道您分享了一些有關客戶提供的見解，但您能區分利用率和庫存累積嗎？然後我還要跟進報銷事宜。

So when we talk about US Renal Care and order rates normalizing, and I think you -- I think what you're really asking is what's the runway for growth over the back part of the year. I think there's some runway for growth. I think we're probably a little bit more than 80% implemented right within the eligible patient population based on the criteria they set up. But I do think there's still opportunity and there's always new patients, right, that come in and begin dialysis that meet the criteria.

因此，當我們談論美國腎臟護理和訂單率正常化時，我認為您——我認為您真正想問的是今年下半年的成長前景如何。我認為還有一定的成長空間。我認為，根據他們設定的標準，我們在符合條件的患者群體中實施的比例可能略高於 80%。但我確實認為還有機會，而且總會有符合標準的新病人進來並開始透析。

So I'd say, with the other mid-size customers, there's a little bit more runway I'd say for growth. We've obviously implemented more recently, right? So we're still in the ramping phase, I think with both IRC and DCI as well as with a number of the smaller customers.

所以我想說，對於其他中型客戶來說，成長空間會更大。我們顯然最近已經實施了更多措施，對嗎？因此，我認為我們與 IRC、DCI 以及一些較小的客戶仍處於成長階段。

On utilization tracking, I would say at least with US Renal Care, which -- and I'll correct the number I gave before, I think for this quarter was 78% of shipments in the first quarter or of revenue in the first quarter. We do have pretty good visibility as to what is utilization versus what is inventory. And that's the basis for which we've amended our guidance and now we're guiding toward the upper end of our range.

關於利用率跟踪，我想說至少對於 US Renal Care 來說，我會糾正我之前給出的數字，我認為本季度的出貨量或收入佔第一季度的 78%。我們確實非常清楚什麼是利用率，什麼是庫存。這就是我們修改指導方針的基礎，現在我們的指導意見正朝著範圍的上限發展。

Got it. Very helpful. On the reimbursement front, so now maybe looking ahead, Medicare Advantage being a bigger share, can we, I guess, assume there's a potential for a reimbursement negotiation with Medicare Advantage in the early phases of the TDAPA period, or is this more of a concrete decision that will coincide with end of TDAPA coverage?

知道了。非常有幫助。在報銷方面，現在也許展望未來，醫療保險優勢計劃 (Medicare Advantage) 佔了更大的份額，我想，我們是否可以假設在 TDAPA 期間的早期階段有可能與醫療保險優勢計劃進行報銷談判，或者這是否是一個更具體的決定，將與 TDAPA 覆蓋範圍的結束相吻合？

Look, I think we're -- our expectation is to enter into negotiations with the MA plans, while the TDAPA is still in force, right? And whether that ends up impacting reimbursement in year three or year four, we don't know yet.

聽著，我認為我們——我們的期望是在 TDAPA 仍然有效的情況下與 MA 計劃進行談判，對嗎？而這是否會影響第三年或第四年的報銷，我們還不知道。

I don't know that there's a lot of precedent for TDAPA launches entering into direct contracts with MA plans. So that's something we're looking to engage in. Obviously, our real-world evidence studies is a big piece of the data that we're hoping to utilize for those negotiations.

我不知道 TDAPA 是否有很多與 MA 計劃直接簽訂合約的先例。這就是我們希望參與的事情。顯然，我們的真實世界證據研究是我們希望用於這些談判的大量數據。

What I could say now that's certainly promising when we look at our claims data, about 40% of our claims are currently MA plans, a large number of plans currently, providing reimbursement. So that's, from our view, all positive.

現在我可以說，當我們查看索賠數據時，這肯定是令人鼓舞的，目前約有 40％ 的索賠是 MA 計劃，目前有大量計劃提供報銷。所以，從我們的角度來看，這都是正面的。

Great. And just made the last one on that front, the 40%. And what would you expect that to grow to or change to by the end of your TDAPA coverage? Thank you.

偉大的。並且剛剛完成了這方面的最後一個，即 40%。您預計在 TDAPA 保險期結束時，該數字會成長或變化到什麼程度？謝謝。

Well, I wouldn't expect it to grow past 50/50, right? Because MA is about 50% of the Medicare-based ESRD population. Most of these patients are Medicare. It's about half fee for service traditional and half MA. So that's about what I would expect.

嗯，我不希望它的成長率超過 50/50，對嗎？因為 MA 約佔醫療保險 ESRD 人口的 50%。這些患者大多數都有醫療保險。服務費大約一半是傳統服務費，一半是 MA 服務費。這就是我所期望的。

So that's why I said I think it's pretty positive that about 40% of our claims are Medicare Advantage. And that's combined with a little bit of commercial and probably some Medicaid as well.

所以我說，我認為我們的索賠中約有 40% 是醫療保險優勢計劃，這是相當積極的。這與少量商業和可能還有一些醫療補助相結合。

Got it. Okay. That's helpful. Thank you.

知道了。好的。這很有幫助。謝謝。

(Operator Instructions) Serge Belanger, Needham & Company.

（操作員指示）Serge Belanger，Needham & Company。

Joe, I guess a couple of questions first on the inpatient segment. You've now been in that market for a year, I think since last April. So just curious how you think about the overall opportunity a year later and how much of the business it could represent relative to the outpatient segment. And then secondly, are there any efforts to modify or improve that reimbursement process at this point? Thanks.

喬，我想先問幾個關於住院部分的問題。我想從去年四月開始，你們已經進入該市場一年了。所以我很好奇您如何看待一年後的整體機會，以及相對於門診部分它能代表多少業務。其次，目前是否有任何努力來修改或改善報銷流程？謝謝。

Yes, we did launch in the inpatient segment last year, but as we've talked about on prior calls, it's a really long ramp, right; to get the product in front of PNT committee, get through PNT committee, right; build champions within these institutions. A lot of them are very academic-minded and want to see what's going on in other institutions.

是的，我們去年確實在住院領域推出了這項服務，但正如我們在之前的電話會議上談到的那樣，這是一個很長的上升過程，對吧？將產品送到 PNT 委員會面前，通過 PNT 委員會，對吧；在這些機構內培養冠軍。他們中的許多人非常具有學術頭腦，想看看其他機構正在發生什麼。

So it's taken a long time to build a little bit of critical mass there and now we're starting to see some progress. And now, we've got a dedicated inpatient team that is now three weeks, I think, in the field and fully operational. So we do think we've got a good runway there and an opportunity to grow the business.

因此，我們花了很長時間才在那裡達到臨界規模，現在我們開始看到一些進展。現在，我們已經有一個專門的住院團隊，我想他們已經在現場工作了三週，並且全面投入工作。因此，我們確實認為我們在那裡擁有良好的發展道路和發展業務的機會。

What it could grow to as a percentage of our business is hard to pin down. Overall, if you look at, in terms of the total market opportunity, the TAM, about 10% of the unit volume flows through inpatient. As we said in the past, we think there's a little bit more durable pricing perhaps on the inpatient side that could lead to a higher dollar value.

它在我們的業務中所佔的比例能成長到多大還很難確定。整體而言，從整體市場機會（TAM）來看，大約有 10% 的單位量流經住院患者。正如我們過去所說的那樣，我們認為住院方面的定價可能會更加持久一些，這可能會帶來更高的美元價值。

And I had mentioned that, we essentially, for April, we doubled our rate of shipments, right, from -- it was 3% of our shipments in the first quarter, in patients about 6% so far, leading into in the second quarter. As a percentage of our overall business, it will really depend upon, right, the timing and scale of bringing on new customers, right?

我曾提到，我們基本上在 4 月將出貨率翻了一番，從第一季的 3% 到第二季的患者出貨量約佔 6%。作為我們整體業務的百分比，它實際上取決於吸引新客戶的時間和規模，對嗎？

Specifically, if an LDO customer comes on and is driving higher volumes, impatient will be a smaller percentage of the business, but that doesn't necessarily mean that it's not going to be material or meaningful, right, as a growth driver. So it's hard to pin down a number of what we expect it to be. It really depends on a lot of variables.

具體來說，如果出現 LDO 客戶並推動銷量增加，那麼不耐煩的客戶在業務中所佔的比例就會較小，但這並不一定意味著它不會成為實質或有意義的成長動力。因此，我們很難確定我們期望的數字。這確實取決於很多變數。

Just changing gears on TDAPA in terms of efforts to modify TDAPA. I'd say there's a few efforts that are currently ongoing. One of the things that we're keeping an eye on in July, the proposed rule for 2026 should come out from CMS.

就修改 TDAPA 的努力而言，只是改變了 TDAPA 的方向。我想說的是目前正在進行一些努力。我們在 7 月關注的事情之一是 CMS 應該會推出 2026 年的擬議規則。

Stakeholders have submitted a large number of comments in terms of potential changes to TDAPA. I think we're hopeful to see something in that proposal for next year that we would view as an improvement for TDAPA. We're keeping an eye on that.

利害關係人就 TDAPA 的潛在變更提交了大量意見。我認為我們希望在明年的提案中看到一些我們認為可以改善 TDAPA 的內容。我們正在密切關注此事。

Separately, there are some legislative initiatives that are going on with stakeholders, working with members of the Hill to hopefully get a bill brought forward later this year that would codify TDAPA in law and also make improvements to TDAPA. But you know, legislation is always an uphill fight certainly in this Congress.

另外，我們正在與利益相關者一起推動一些立法舉措，與國會議員合作，希望在今年稍後提出一項法案，將 TDAPA 編入法律，並對 TDAPA 進行改進。但你知道，在本屆國會中，立法永遠是一場艱苦的戰鬥。

But there is a lot of, I'd say, momentum amongst stakeholders that want to see change it TDAPA, to make it either longer in duration, more sustainable over time, and, perhaps, better drive utilization of innovative therapies. Thanks.

但我想說，利害關係人中有很多動力希望看到 TDAPA 發生改變，使其持續時間更長、隨著時間的推移更具可持續性，並且可能更好地推動創新療法的利用。謝謝。

Thanks.

謝謝。

Thank you. Now, I'll turn the conference over to Dan Ferry for return questions from the audience.

謝謝。現在，我將會議交給丹費裡 (Dan Ferry)，讓他回答觀眾提出的問題。

Thank you, operator. Joe, we do have one written question for the from the audience here.

謝謝您，接線生。喬，我們確實有一個來自觀眾的書面問題要問。

Can you provide any feedback from providers or customers on their experience with DefenCath to date?

您能否提供供應商或客戶迄今為止使用 DefenCath 的體驗回饋？

Okay. That's a good question, Dan. I'm going to actually ask Liz to touch on that from a medical standpoint in terms of what we've heard and seen from customers. Good.

好的。這是個好問題，丹。我實際上想請 Liz 從醫學的角度根據我們從客戶那裡聽到和看到的情況來談談這個問題。好的。

Sure. So I would say our customer feedback has been very positive overall. Our clinical implementation and excellence team works really closely with our customers to ensure a smooth transition to DefenCath. I think many have been surprised how easily DefenCath fits into their current work flow, and the clinicians overall have been pretty quick to adopt and introduce patients.

當然。所以我想說我們的客戶回饋整體來說非常正面。我們的臨床實施和卓越團隊與客戶密切合作，以確保順利過渡到 DefenCath。我想很多人都對 DefenCath 如此輕鬆地融入他們當前的工作流程感到驚訝，而且臨床醫生總體上也很快就能採用它並把它介紹給患者。

I also think our reimbursement support services with prospectus have been instrumental in supporting customers with the nuances of TDAPA and NTAP claims, taking that unknown factor out of the aspect. So overall, it's been really positive.

我還認為，我們的報銷支援服務（包括招股說明書）在幫助客戶了解 TDAPA 和 NTAP 索賠的細微差別方面發揮了重要作用，消除了未知因素。總體而言，這是非常積極的。

Thanks, Liz.

謝謝，莉茲。

All right. Thanks, Liz.

好的。謝謝，莉茲。

Joe, with that said, I don't have any other further questions from the audience. (multiple speakers) Operator, you may close the call. Perfect.

喬，話雖如此，觀眾們我沒有其他問題了。（多位發言者）接線員，您可以結束通話了。完美的。

Well, thank you, everybody.

好的，謝謝大家。

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。