CorMedix Inc (CRMD) 2024 Q2 法說會逐字稿

Good day, and welcome to the CorMedix Inc. second quarter 2024 financial results conference call. (Operator Instructions) Please note, this event is being recorded.

美好的一天，歡迎參加 CorMedix Inc. 2024 年第二季財務業績電話會議。（操作員說明）請注意，正在記錄此事件。

I'd now like to turn the conference over to your host today, Daniel Ferry. Please go ahead.

我現在想把今天的會議交給主持人丹尼爾費裡 (Daniel Ferry)。請繼續。

Good morning, and welcome to the CorMedix second quarter 2024 earnings conference call. Leading the call today is Joe Todisco, Chief Executive Officer of CorMedix and he is joined by Dr. Matt David, Executive Vice President and CFO; Beth Zelnick Kaufman, EVP and Chief Legal 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 2024 年第二季財報電話會議。今天的電話會議由 CorMedix 執行長 Joe Todisco 主持，執行副總裁兼財務長 Matt David 博士也參加了會議； Beth Zelnick Kaufman，執行副總裁兼首席法務長； Liz Hurlburt，執行副總裁兼首席臨床策略和營運長；和艾琳·米斯特里（Erin Mistry），執行副總裁兼首席商務官。

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 meaning 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.

在開始之前，我想提醒大家，在電話會議期間，管理階層可能會做出 1995 年《私人證券訴訟改革法案》規定的所謂前瞻性陳述。這些陳述不是關於管理階層對公司前景和未來財務狀況的預期、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 risks 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. CorMedix may not actually achieve the goals or plans described in these forward-looking statements. Investors should not place undue reliance on these statements. CorMedix does not intend to update these forward-looking statements, except as required by law.

由於各種重要因素，實際結果可能與這些陳述所依據的估計和預測有重大差異，包括 CorMedix 向 SEC 提交的文件中更詳細描述的風險和不確定性，這些文件可在 SEC 網站上免費取得或根據CorMedix 的要求。CorMedix 可能實際上無法實現這些前瞻性聲明中所述的目標或計劃。投資者不應過度依賴這些陳述。CorMedix 不打算更新這些前瞻性陳述，除非法律要求。

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.

此時此刻，我很高興將電話轉給 CorMedix 執行長 Joe Todisco。喬，請繼續。

Thanks, Dan. Good morning, everyone, and thank you for joining us on this call.

謝謝，丹。大家早安，感謝您參加我們的這次電話會議。

As we reach the midpoint in the financial year, I'm incredibly pleased with the progress the company has made related to the launch of DefenCath, and I'm optimistic about the sales trajectory we have seen through only the first few weeks of the outpatient launch.

隨著我們進入財政年度的中期，我對該公司在推出 DefenCath 方面取得的進展感到非常滿意，並且我對我們在門診的前幾週看到的銷售軌跡感到樂觀發射。

CorMedix commenced the inpatient launch of DefenCath on April 15, and commenced the outpatient launch during the first week of July, just after the close of the second quarter. The commercial launch milestone marks the culmination of the efforts of countless individuals, including CorMedix employees, contractors and consultants, who worked tirelessly over the last decade to bring this innovative drug product to patients in need.

CorMedix 於 4 月 15 日開始在住院患者中推出 DefenCath，並在 7 月第一周第二季結束後開始在門診患者中推出。這個商業上市里程碑標誌著無數個人（包括 CorMedix 員工、承包商和顧問）努力的頂峰，他們在過去十年中不知疲倦地工作，將這種創新藥物產品帶給有需要的患者。

I'm extremely proud of this achievement, and I'm excited about the potential for DefenCath utilization and the resulting impact DefenCath can have on patient infection rates. Though the inpatient launch of DefenCath commenced on April 15, as we communicated earlier, the inpatient sales cycle is relatively long.

我對這項成就感到非常自豪，並且對 DefenCath 的利用潛力以及 DefenCath 對患者感染率的影響感到興奮。雖然DefenCath在4月15日就開始在住院部上市，但正如我們之前溝通的那樣，住院部的銷售週期相對較長。

And our initial efforts have been focused on engaging customers to champion DefenCath for P&T formulary review at hospitals and health systems. In this regard, we have seen significant progress in terms of meetings scheduled over the upcoming months. And from the handful of meetings that have already occurred, we are pleased with the majority of outcomes.

我們最初的努力重點是吸引客戶支持 DefenCath 在醫院和健康系統進行 P&T 處方審查。在這方面，我們在未來幾個月安排的會議方面看到了重大進展。從已經舉行的少數會議來看，我們對大多數成果感到滿意。

We do expect a lag between P&T formulary approval and facility ordering, and we may have more -- and we have many more P&T meetings scheduled between now and the end of this calendar year. In light of this long sales cycle, second quarter sales were expectedly modest, consisting primarily of trade stocking for inpatient facilities.

我們確實預計 P&T 處方批准和設施訂購之間會存在滯後，而且我們可能會有更多的滯後——而且從現在到本日曆年年底，我們安排了更多的 P&T 會議。鑑於銷售週期較長，預計第二季的銷售量將不大，主要包括住院設施的貿易庫存。

We expect inpatient sales to begin to ramp in the fourth quarter as DefenCath is reviewed, added to formulary and adopted into hospital workflows for patient use. We have seen some inventory begin to flow to those inpatient institutions that have completed formulary reviews, and we are optimistic of increased order flow as more hospitals and systems, hopefully approved DefenCath and added to their respective formularies throughout the year. The outpatient launch of DefenCath officially commenced on July 1 with initial orders placed in June, and material product shipments beginning the week of July 8.

我們預計，隨著 DefenCath 得到審查、添加到處方集並納入醫院工作流程供患者使用，住院患者銷售額將在第四季度開始增加。我們已經看到一些庫存開始流向那些已完成處方審查的住院機構，並且我們對訂單流的增加持樂觀態度，因為更多的醫院和系統預計將在今年批准 DefenCath 並添加到各自的處方中。DefenCath 於 7 月 1 日在門診正式啟動，首批訂單於 6 月下達，材料產品於 7 月 8 日這一周開始出貨。

As we announced earlier this morning, we have recorded unaudited quarter-to-date sales of $5.2 million as of August 13. Our third quarter sales have been exclusively to small and midsized dialysis operators, and we have verified pull-through to the clinic level for more than 95% of those shipments.

正如我們今天早上早些時候宣布的那樣，截至 8 月 13 日，我們未經審計的季度迄今銷售額為 520 萬美元。我們第三季的銷售專門針對中小型透析業者，我們已經驗證了 95% 以上的出貨量已進入診所水準。

To that extent, there is very little, if any, trade stocking in these third quarter net sales figures. In terms of onboarding new outpatient dialysis providers, the company believes we're in late stages of negotiations with one of the top dialysis providers in the country for the implementation of DefenCath as well as multiple smaller and midsized providers, and we are optimistic we will be operationalizing new commercial supply agreement shortly.

從這個意義上說，第三季淨銷售數據中幾乎沒有貿易庫存（如果有的話）。在新的門診透析提供者入職方面，該公司認為，我們正與該國頂級透析提供者之一以及多家中小型提供者就實施 DefenCath 進行談判，我們對此持樂觀態度很快就會實施新的商業供應協議。

As I stated at the opening of these remarks, we have seen a positive sales trend throughout our first five weeks of outpatient shipments, coming entirely from small and midsized dialysis operators, and we expect that growth trend to continue throughout the year as existing customers expand DefenCath to newly identified patients.

正如我在開場白中所說，我們在門診發貨的前五週看到了積極的銷售趨勢，完全來自中小型透析運營商，我們預計隨著現有客戶的擴大，這一增長趨勢將在全年持續下去DefenCath 給新發現的患者。

In addition, we are hopeful to see the commencement of sales to new accounts before the end of the third quarter. From a market access standpoint, outpatient reimbursement under TDAPA commenced on July 1 and applies to all Medicare fee for service patients, which comprises roughly 45% of all ESRD patients in the United States. Medicare Advantage, comprising an additional 45% of ESRD patients remains an opportunity for growth and expansion for the DefenCath reimbursement.

此外，我們希望在第三季末之前看到新客戶開始銷售。從市場准入的角度來看，TDAPA 下的門診報銷於 7 月 1 日開始，適用於服務患者的所有 Medicare 費用，這些患者約占美國所有 ESRD 患者的 45%。Medicare Advantage（包括另外 45% 的 ESRD 患者）仍然是 DefenCath 報銷成長和擴大的機會。

We have been engaged with all major Medicare Advantage organizations across the country, and we are happy to report that UnitedHealthcare, the largest MA plan in the country in terms of covered lives, which accounts for roughly 30% of Medicare Advantage enrollment has confirmed that they will provide comparable TDAPA reimbursement for DefenCath beginning on September 1. Humana, which comprises roughly 20% of Medicare Advantage population, has also confirmed that they will provide TDAPA reimbursement, which may vary depending on provider contracts.

我們已經與全國所有主要的 Medicare Advantage 組織進行了合作，我們很高興地報告，UnitedHealthcare 是該國承保範圍最大的 MA 計劃，約佔 Medicare Advantage 參保人數的 30%，該計劃已確認他們將從9月1 日開始為DefenCath 提供類似的TDAPA 報銷。Humana 約佔 Medicare Advantage 人口的 20%，該公司還確認將提供 TDAPA 報銷，報銷金額可能會根據提供者合約的不同而有所不同。

As we progress through our first year of launch, the company intends to remain engaged with Medicare Advantage plans to ensure adequate reimbursement to operators. From a long-term perspective, the company believes that ESRD Medicare patients in general will continue to migrate from Medicare fee-for-service into Medicare Advantage plans, and that the value-based care proposition for DefenCath will resonate with MA plans, and hopefully result in long-term sustainable separate reimbursement in this patient segment.

隨著我們推出第一年的進展，該公司打算繼續參與 Medicare Advantage 計劃，以確保營運商獲得足夠的報銷。從長遠來看，該公司認為，ESRD Medicare 患者總體上將繼續從 Medicare 按服務收費轉向 Medicare Advantage 計劃，並且 DefenCath 基於價值的護理主張將與 MA 計劃產生共鳴，並希望導致該患者群體長期可持續的單獨報銷。

Shifting gears to our clinical developments. We announced in the second quarter that we received supportive feedback from FDA related to our proposed clinical pathway for adult Total Parenteral Nutrition or TPN, subject to the agency's review of our final study protocol. I'm happy to announce that this past week, we have submitted our final protocol to FDA.

轉向我們的臨床開發。我們在第二季宣布，我們收到了 FDA 對我們擬議的成人全腸外營養（TPN）臨床路徑的支持性回饋，具體取決於該機構對我們最終研究方案的審查。我很高興地宣布，上週我們已向 FDA 提交了最終方案。

And subject to FDA's concurrence, we expect to begin patient enrollment in the first quarter of 2025. We have posted on the company's website an updated corporate presentation that it now includes market research information related to TPN. There remains a significant unmet medical need in this patient population, with up to 26% of TPN patients having a catheter-related infection and those patients having increased morbidity and mortality rates. Market research estimates that the addressable market opportunity in TPN is approximately 4.7 million TPN infusions per year.

經 FDA 同意，我們預計將於 2025 年第一季開始患者入組。我們在公司網站上發布了更新的公司演示文稿，其中現在包含與 TPN 相關的市場研究資訊。該患者群體中仍有大量未滿足的醫療需求，高達 26% 的 TPN 患者患有導管相關感染，這些患者的發病率和死亡率增加。市場研究估計，TPN 的潛在市場機會約為每年 470 萬次 TPN 輸注。

The company's goal is to obtain FDA approval for an expanded use of our taurolidine and heparin catheter lock solution in TPN in the 2027 to 2028 time frame, as we estimate annual peak sales potential in this indication to be in the range of $150 million to $200 million, incrementally beyond hemodialysis.

該公司的目標是獲得FDA 批准，在2027 年至2028 年期間擴大我們的牛磺羅定和肝素導管封管解決方案在TPN 中的使用，因為我們估計該適應症的年峰值銷售潛力在1.5 億美元至200 美元之間百萬，逐漸超越血液透析。

We'll provide investors with updates on progress as we move forward. From a clinical budget standpoint, we anticipate the study to cost between $10 million and $12 million, with the majority of expense spending to 2025 and 2026 calendar years.

隨著我們的進展，我們將向投資者提供最新進展。從臨床預算的角度來看，我們預計研究的費用將在 1,000 萬至 1,200 萬美元之間，其中大部分費用支出到 2025 年和 2026 年。

Simultaneously with our adult TPN study, we will also be commencing a few additional clinical initiatives. The first is a study in pediatric hemodialysis. This will be a relatively small study spread over several years as we expect patient enrollment to be a challenge, given an extremely small patient population and the need for very personalized protocols for these ultra-vulnerable patients.

在進行成人 TPN 研究的同時，我們也將啟動一些額外的臨床措施。第一個是兒科血液透析的研究。這將是一項持續數年的相對較小的研究，因為我們預計患者入組將是一個挑戰，因為患者人數極少，並且需要為這些極度脆弱的患者制定非常個性化的方案。

This pediatric study is a post-marketing requirement under the Pediatric Research Equity Act by the FDA, and we have submitted to FDA a final study protocol. Subject to FDA's concurrence, we have plans to begin patient enrollment in early 2025. We expect this study to cost between $4 million and $6 million spread over four to five years.

這項兒科研究是 FDA 兒科研究公平法案下上市後的要求，我們已向 FDA 提交了最終研究計畫。經 FDA 同意，我們計劃於 2025 年初開始患者入組。我們預計這項研究將在四到五年內花費 400 萬至 600 萬美元。

In addition to our adult TPN and pediatric HD studies, we plan to commence two other clinical initiatives in 2025. The first is an 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 central venous catheter.

除了成人 TPN 和兒科 HD 研究外，我們還計劃在 2025 年啟動另外兩項臨床計畫。第一個是針對高風險族群的擴大准入計劃，包括但不限於兒科 TPN、患有難治性腹膜炎的腹膜透析患者和使用中心靜脈導管的中性粒細胞減少腫瘤患者。

These high-risk patients are those that have exhausted other infection prevention methods and unfortunately, remain at significant risk for comorbidities and mortality. The cost for expanded access is expected to be less than $750,000 a year, primarily in the form of free product and distribution costs. And we expect to generate data that supports further label expansion and complements our adult TPN program.

這些高風險患者是那些已經用盡其他感染預防方法的患者，不幸的是，他們仍然面臨合併症和死亡的巨大風險。擴大訪問範圍的成本預計每年低於 750,000 美元，主要表現為免費產品和分銷成本。我們期望產生支持進一步擴展標籤並補充我們的成人 TPN 計劃的數據。

The other clinical initiative, which is perhaps most meaningful from a potential data value standpoint, is a real-world evidence study of DefenCath in adult hemodialysis patients that we will run in cooperation with one of our existing commercial partners.

另一項臨床舉措，從潛在數據價值的角度來看，可能是最有意義的，是對成人血液透析患者進行DefenCath 的真實世界證據研究，我們將與我們現有的商業合作夥伴之一合作開展這項研究。

Our hope with this study, which we expect to take approximately 24 months and cost less than $1 million per year, would be to generate real-world evidence around the impact of DefenCath utilization on cost of patient care, infection rates, hospitalizations, mortality and multiple other metrics such as lost chairtime and antibiotic use ultimately, we would look to utilize this data in our post adaptive period to negotiate future sustainable reimbursement for Medicare Advantage plans and other value-based care contracting entities.

這項研究預計需要大約24 個月的時間，每年的費用不超過100 萬美元，我們希望透過這項研究能夠產生有關DefenCath 使用對患者護理成本、感染率、住院率、死亡率和死亡率的影響的真實證據。

I'd now like to turn the call over to Matt to discuss the company's second quarter financial results and financial position. Matt?

我現在想把電話轉給馬特，討論公司第二季的財務表現和財務狀況。馬特？

Thanks, Joe, and good morning, everyone. I'm pleased to be here today to provide an overview of our second quarter 2024 financial results as well as an update on CorMedix's cash position. The company has filed its quarterly report on Form 10-Q for the quarter ended June 30, 2024. I urge you to read the information contained in the report for a more complete discussion of our financial results. With respect to our second quarter of 2024 financial results, our net revenue for the second quarter of 2024 amounted to $0.8 million.

謝謝喬，大家早安。我很高興今天能夠概述我們 2024 年第二季的財務表現以及 CorMedix 現金狀況的最新情況。該公司已提交截至 2024 年 6 月 30 日的季度 10-Q 表格季度報告。我敦促您閱讀報告中包含的信息，以便對我們的財務表現進行更完整的討論。就我們 2024 年第二季的財務表現而言，我們 2024 年第二季的淨收入為 80 萬美元。

This marks the first time that CorMedix has reported revenue from the U.S. distribution of DefenCath. Our net loss was approximately $14.2 million or $0.25 per share compared with a net loss of $11.3 million or $0.25 per share in the second quarter of 2023.

這標誌著 CorMedix 首次報告 DefenCath 在美國發行的收入。我們的淨虧損約為 1,420 萬美元，即每股 0.25 美元，而 2023 年第二季的淨虧損為 1,130 萬美元，即每股 0.25 美元。

The higher net loss recognized in 2024 compared with 2023 was driven by an increase in SG&A expenses versus the second quarter of 2023 in anticipation of commercial launch. Operating expenses in the second quarter of 2024 increased approximately 32% to $15.6 million compared with $11.8 million in the second quarter of 2023.

與 2023 年相比，2024 年確認的淨虧損較高，是由於預計商業推出而導致 SG&A 費用較 2023 年第二季增加。2024 年第二季的營運支出成長約 32%，達到 1,560 萬美元，而 2023 年第二季的營運支出為 1,180 萬美元。

R&D expense decreased by approximately 86% to $0.7 million, driven by the approval of DefenCath. As a result of the post-FDA approval of commercial operations, costs related to medical affairs and certain personnel expenses that supported R&D efforts prior to the FDA approval of DefenCath have been recognized in sales and marketing or G&A expense.

受 DefenCath 批准的推動，研發費用下降約 86% 至 70 萬美元。由於 FDA 批准商業運營後，與醫療事務相關的成本以及在 FDA 批准 DefenCath 之前支持研發工作的某些人員費用已在銷售和營銷或一般管理費用中得到確認。

SG&A expense increased approximately 113% to $14.9 million in the second quarter of 2024 compared with $7 million in the second quarter of 2023. CorMedix is now reporting sales and marketing expense and general and administrative or G&A expense as separate line items. On an apples-to-apples basis, sales and marketing expense increased 127% to $7.4 million in the second quarter of 2024 compared with $3.3 million in the second quarter of 2023.

2024 年第二季的 SG&A 費用成長約 113%，達到 1,490 萬美元，而 2023 年第二季為 700 萬美元。CorMedix 現在將銷售和行銷費用以及一般和管理或一般及行政費用作為單獨的行項目報告。以同類計算，2024 年第二季的銷售和行銷費用成長 127%，達到 740 萬美元，而 2023 年第二季為 330 萬美元。

G&A expense increased 103% to $7.6 million in the second quarter of 2024 versus $3.8 million in the second quarter of 2023. The increase in sales and marketing expense was attributable primarily to increased marketing efforts and new personnel, inclusive of our field sales organization and support for the commercial launch of DefenCath as well as certain expenses previously a part or component of the R&D prior to FDA approval.

2024 年第二季的一般管理費用成長 103%，達到 760 萬美元，而 2023 年第二季為 380 萬美元。銷售和行銷費用的增加主要歸因於行銷工作的增加和新人員的增加，包括我們的現場銷售組織和對DefenCath 商業推出的支持，以及在FDA 批准之前作為研發的一部分或組成部分的某些費用。

The increase in G&A expense was primarily due to increases in personnel costs in preparation for support activities related to the commercial launch as well as certain expenses previously expensed as a component of R&D prior to FDA approval.

一般管理費用的增加主要是由於準備與商業發布相關的支援活動的人員成本增加以及在 FDA 批准之前作為研發組成部分支出的某些費用。

In addition to other drivers, we saw an increase in legal and compliance costs compared to the prior year. We recorded net cash used in operations during the second quarter of 2024 of $14 million compared with net cash used in operations of $8.6 million in the second quarter of 2023.

除了其他驅動因素之外，我們還發現法律和合規成本與前一年相比有所增加。我們記錄的 2024 年第二季營運中使用的淨現金為 1,400 萬美元，而 2023 年第二季營運中使用的淨現金為 860 萬美元。

The increase is primarily driven by an increase in net loss attributable to a net increase in operating expenses. The company has cash and cash equivalents of $45.6 million as of June 30, 2024.

這一增長主要是由於營業費用淨增加導致的淨虧損增加所致。截至2024年6月30日，該公司擁有現金及現金等價物為4,560萬美元。

As we have discussed previously, we expect our operating expenses, especially sales and marketing and G&A to remain at the current levels, given the growth of the company and the cost driven by the commercial launch of DefenCath. CorMedix continues to expect 2024 quarterly operating expenses to range from around $15 million to $18 million to support commercial infrastructure and the ongoing launch of DefenCath.

正如我們之前所討論的，考慮到公司的成長以及 DefenCath 商業推出所驅動的成本，我們預計我們的營運支出，特別是銷售和行銷以及一般管理費用將保持在當前水平。CorMedix 繼續預計 2024 年季度營運費用約為 1500 萬美元至 1800 萬美元，以支援商業基礎設施和 DefenCath 的持續推出。

We believe our cash, cash equivalents, short-term investments and projected future operating cash flow gives the company the ability to fund operations for at least 12 months, and to fund the commercial launch of DefenCath through to breakeven EBITDA, which may occur on a run rate basis by the end of 2024, assuming we maintain our current growth trajectory of sales from existing key outpatient accounts as well as achieve forecasted shipments to new accounts by the beginning of fourth quarter.

我們相信，我們的現金、現金等價物、短期投資和預計的未來營運現金流使公司有能力為至少12 個月的營運提供資金，並為DefenCath 的商業推出提供資金，以實現盈虧平衡的EBITDA，這可能發生在假設我們維持現有主要門診客戶目前的銷售成長軌跡，並在第四季度初實現新客戶的預測出貨量，則到 2024 年底的運作率為基礎。

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

我現在將把電話轉回給喬，讓他發表結束語。喬？

Thanks, Matt. CorMedix is executing well on our key objectives and is hopeful to provide more substantive updates on sales progress and commercial uptake at DefenCath in our next quarterly call in November. I appreciate everyone's continued support and CorMedix, and I'm happy to open the line for questions.

謝謝，馬特。CorMedix 在我們的關鍵目標上執行得很好，並希望在 11 月的下一個季度電話會議中提供有關 DefenCath 的銷售進度和商業應用的更多實質更新。我感謝大家的持續支持和 CorMedix，我很高興開通提問專線。

(Operator Instructions).

（操作員說明）。

Gregory Renza with RBC Capital Markets.

加拿大皇家銀行資本市場部的格雷戈里·倫扎 (Gregory Renza)。

Hi Joe, and team. It's Anish on for Greg. Congrats on the progress this quarter and thanks for taking our questions. Just a couple from us. First, just when you think about CLABSI, how do readmission rates for CLABSI, compared to CRBSI? And how would you think about gearing your education and marketing strategy for DefenCath accordingly? And second, on the granted pass-through status for DefenCath, how can this be leveraged to facilitate uptake? Thanks so much.

嗨，喬，和團隊。格雷格的安尼什上場了。恭喜本季取得的進展，並感謝您提出我們的問題。只有我們幾個人。首先，當您考慮 CLABSI 時，與 CRBSI 相比，CLABSI 的再入院率如何？您如何考慮相應地調整 DefenCath 的教育和行銷策略？其次，關於 DefenCath 所獲得的傳遞地位，如何利用這一點來促進採用？非常感謝。

All right. Thanks, Anish. So I think what you're asking is the difference between a CLABSI and the CRBSI, if I'm not mistaken, and kind of how that may show differently in the data. So I'm going to let Liz, just from a clinical definition standpoint, kind of chime in on the difference between these two. But I think why that's relevant is from a TPN standpoint, we are designing the study for CLABSI, right, versus CRBSI.

好的。謝謝，安尼什。所以我想你問的是 CLABSI 和 CRBSI 之間的差異（如果我沒記錯的話），以及資料中的不同表現。因此，我將讓莉茲從臨床定義的角度來談談這兩者之間的差異。但我認為為什麼這是相關的，是從 TPN 的角度來看，我們正在為 CLABSI 設計研究，對吧，而不是 CRBSI。

And I think, the way to somewhat look at it before Liz gives the definition is that, I guess, all CRBSIs are CLABSIs, but all CLABSIs are not CRBSIs, right? CLABSI is a little bit of a broader determination. But go ahead, Liz.

我認為，在 Liz 給出定義之前先看一下它，我想所有 CLABSI 都是 CLABSI，但所有 CLABSI 都不是 CLABSI，對嗎？CLABSI 是一個更廣泛的測定。但繼續吧，莉茲。

Yes, exactly. So like Joe said, CRBSI is a subset of the larger CLABSI. And CRBSIs need clinical correlations. So signs of sepsis or positive peripheral blood cultures in the absence of an obvious source other than the CVC. And CLABSI, which is your more general term is a primary bloodstream infection in a patient that has had a central line within the 48-hour period before these symptoms develop.

是的，完全正確。正如 Joe 所說，CRBSI 是更大的 CLABSI 的子集。CRBSI 需要臨床相關性。因此，在除 CVC 之外沒有明顯來源的情況下，出現膿毒症或週邊血液培養陽性的跡象。CLABSI，這是一個更通用的術語，是指在出現這些症狀之前 48 小時內接受過中心靜脈插管的患者的原發性血流感染。

So you can think of CLABSI as an umbrella. And then there's a subset of types of infections after that that require different blood cultures, or other clinical correlation to confirm them.

所以你可以把CLABSI想像成一把雨傘。然後還有一部分類型的感染需要不同的血液培養或其他臨床相關性來確認。

Thanks, Liz. And I think, to get to your question on pass-through status. So what pass-through status allows is for the providers that install catheters, and utilize DefenCath during that catheter installation to bill for the product on a buy-and-bill basis, similar to any other kind of Medicare B product, right? So that's an ASP+. It's a small part of the segment, but I think that it's meaningful, because it is the first time the patient is getting the catheter, right?

謝謝，莉茲。我想，是為了回答你關於傳遞狀態的問題。那麼，直通狀態允許的提供者安裝導管，並在導管安裝期間利用 DefenCath 在購買和計費的基礎上對產品進行計費，類似於任何其他類型的 Medicare B 產品，對吧？這就是 ASP+。雖然只是一小部分，但我認為這是有意義的，因為這是患者第一次接受導管，對吧？

So, we want to protect the line from the start. It's the opportunity utilize DefenCath from the beginning of each patient. So that's essentially why we see it as meaningful, even though it's a small part of the population.

因此，我們要從一開始就保護線路。這是每個患者從一開始就使用 DefenCath 的機會。這就是為什麼我們認為它有意義，儘管它只是人口的一小部分。

Great. Thanks I appreciate all the color.

偉大的。謝謝我欣賞所有的顏色。

No problem.

沒問題。

Jason Butler with Citizens JMP.

Jason Butler 與 Citizens JMP。

Jason Butler

賈森巴特勒

Hi thanks for taking the questions and congrats on the progress. First one, just in terms of the run rate for 3Q, how should we think about the $5.2 million, and growth beyond that? I guess what I'm asking is, do you expect there to be essentially time taken now for those initial centers, to work through those initial orders? Or should we see continued orders beyond the $5.2 million? And then, can you give us a sense of how many centers in the outpatient setting you're actually seeing, pull-through from? Thanks.

您好，感謝您提出問題並祝賀取得的進展。第一個，僅就第三季的運行率而言，我們應該如何看待 520 萬美元以及除此之外的成長？我想我要問的是，您是否預計這些初始中心現在需要花費大量時間來處理這些初始訂單？或者我們應該看到超過 520 萬美元的持續訂單？然後，您能否讓我們了解您實際上在多少門診中心就診、從中轉過來？謝謝。

Thanks, Jason. So that's a - yes, from - on the $5.2 million, I think what I'm comfortable saying is that we've seen consistent orders repeatedly over the last four weeks. And we're seeing those at the clinic level, right, with repeats and restocking of similar sized orders. So that gives us the impression of those clinics are pulling that through into the patients, which is why I'm comfortable saying that we don't believe there's much, if any, trade stocking in that third quarter number.

謝謝，傑森。所以這是 - 是的，從 - 520 萬美元開始，我想我可以放心地說的是，我們在過去四個星期內反复看到了一致的訂單。我們在診所層級看到了類似規模的訂單的重複和補貨，對吧。因此，這給我們的印像是，這些診所正在將這一點滲透到患者身上，這就是為什麼我可以放心地說，我們認為第三季的數據中沒有太多（如果有的話）貿易庫存。

So I hate to guide you what the back part of the quarter is going to look like and all of the crystal ball. But I feel good about what we've seen, from those first four weeks, four and a half weeks of shipments. In terms of how many centers, again, I prefer not give an exact number, it is several hundred that we are currently shipping to.

所以我不想告訴你本季的後半部以及整個水晶球會是什麼樣子。但我對我們在前四週、四週半的出貨過程中所看到的情況感到滿意。至於有多少個中心，我不想給出確切的數字，我們目前正在運送到數百個。

Okay. Great. I think could you just walk us through the comments that Matt gave about hitting breakeven by the end of '24 again? And what assumptions we would need to consider to get to breakeven by the end of '24? Thanks.

好的。偉大的。我想你能否向我們介紹馬特關於在 24 年底再次實現損益平衡的評論？為了在 24 年底前達到損益平衡，我們需要考慮哪些假設？謝謝。

Yes. Look, I think you've got a good sense for what our operating expense is. We've guided at $15 million to $18 million OpEx. I think we came in at the low point of that for this quarter. Maybe it ticks up a little bit as we get to the back part of the year. I think we've guided you on future clinical costs, which really don't kick in until next year and the year after.

是的。聽著，我認為您對我們的營運費用很清楚。我們指導營運支出為 1500 萬至 1800 萬美元。我認為我們正處於本季的最低點。當我們進入今年下半年時，可能會上升。我認為我們已經為您提供了未來臨床費用的指導，這些費用實際上要到明年和後年才會生效。

And even if you overlay those on top of each other, right, or - I think we're designing fairly modestly priced clinical programs that at peak, maybe $3 million to $4 million in a quarter, right? Probably in late '25 or '26. So the amount of revenue or gross margin needed to cover the OpEx, I think gives you a sense of where we need to be running at. So you've seen our first kind of five weeks of shipments.

即使你將這些疊加在一起，對吧，或者 - 我認為我們正在設計價格相當適中的臨床項目，在高峰期，一個季度可能會達到 300 萬到 400 萬美元，對吧？大概是 25 年末或 26 年。因此，我認為覆蓋營運支出所需的收入或毛利率可以讓您了解我們需要在哪裡運行。您已經看到了我們第一批五週的出貨情況。

I think it's conceivable that if we - and this is all with small and midsized dialysis operators. So if and when, hopefully, we do onboard some larger accounts and we see increased volume move in the back part of the year. I think that breakeven EBITDA is certainly achievable before the end of the year.

我認為這是可以想像的，如果我們 - 這都是中小型透析操作員。因此，如果我們有希望的話，我們會加入一些較大的帳戶，並且我們會看到今年下半年交易量的增加。我認為，年底前達到損益兩平的 EBITDA 是肯定可以實現的。

Great. Thanks for taking the questions.

偉大的。感謝您提出問題。

Les Sulewski with Truist.

Les Sulewski 與 Truist。

Good morning. Thanks for taking my questions. Can you just talk about the progress on conversations on the dialysis operators, particularly the larger ones? And I guess, separately, what percentage of the market has your sales team touched? And is there are any reasons you perhaps are hearing any sort of hesitation on adoption? Can you speak to those? And then I have two follow-ups?

早安.感謝您回答我的問題。您能談談關於透析操作員（尤其是較大的透析操作員）的對話進度嗎？我想，您的銷售團隊分別觸及了多少比例的市場？您可能會聽到對收養有任何猶豫的原因嗎？你能和那些人談談嗎？然後我有兩個後續行動？

All right. Thanks, Les. So obviously, we've - I think we've been pretty candid that we're in discussions with one of the Top two, right? Certainly, I know we talked about that. On the last call, I'd say that, that remains the case. I do feel like we're pretty close. And I think what I would comment on timing, which is kind of what I think you're asking is that when you're dealing with larger organizations with bunch of multiple functional areas that need to weigh in on a contract.

好的。謝謝，萊斯。很明顯，我們 - 我認為我們非常坦誠地表示，我們正在與前兩名之一進行討論，對吧？當然，我知道我們討論過這件事。在最後一次通話中，我想說，情況仍然如此。我確實覺得我們很接近。我想我要對時機發表評論，我認為您所問的是，當您與具有多個職能領域的大型組織打交道時，需要權衡合約。

That process has maybe taking a little longer than I expected. So I'm still optimistic about our ability to move forward, and the signals that I've received have been very positive. On one of the other LDOs, I do think they're taking a wait-and-see approach, and we'll be reengaging later in the year. In terms of percent of the market touched, right? A lot of the decision-making, whether it's an SBO, MDO or LDL that comes from the top down, right?

這個過程可能比我預期的要長一些。因此，我仍然對我們前進的能力持樂觀態度，而且我收到的訊號非常積極。對於其他 LDO，我確實認為他們正在採取觀望態度，我們將在今年稍後重新參與。就所觸及的市場百分比而言，對吧？很多決策，無論是 SBO、MDO 還是 LDL，都是由上而下的，對嗎？

So I'd say we're touching - of the top 20 accounts that represent 99% of dialysis, we're touching them all, right? So the field team right now is focused on probably smaller to midsized accounts and pull-through, as well as the inpatient formulary process, and that's where we want them deployed. There was a third part of your question was - I apologize I'm...

所以我想說我們正在接觸——在代表 99% 透析的前 20 個帳戶中，我們正在接觸所有帳戶，對嗎？因此，現場團隊現在的重點可能是中小型帳戶和拉動，以及住院處方流程，這就是我們希望部署他們的地方。你的問題的第三部分是 - 我很抱歉我......

Just if you're hearing any sort of hesitation on adoption?

如果您聽到對收養有任何猶豫？

Look, as I said, I think some are waiting to see what others are doing, right? I think you have some smaller operators that may be less familiar with - had a process TDAPA or reimbursement, and we're trying to educate on that. So that it's a little bit more familiar. It is still a relatively new reimbursement platform.

聽著，正如我所說，我認為有些人正在等著看其他人在做什麼，對嗎？我認為你們有一些較小的運營商可能不太熟悉 - 有一個 TDAPA 或報銷流程，我們正在努力對此進行教育。這樣就比較熟悉一點了。它仍然是一個相對較新的報銷平台。

It's only a couple of years and does change, right, even TDAPA change last year. So there is some education that we are doing with the smaller - certainly the smaller operators on how to process reimbursement.

這才幾年的時間，確實發生了變化，對吧，甚至去年的 TDAPA 也發生了變化。因此，我們正在對較小的運營商（當然是較小的運營商）進行一些關於如何處理報銷的教育。

That's helpful. On the $5.2 million. Can you speak to perhaps the weekly progression of that? And then the 95% pull-through rate to the clinics, do you have an indication what percentage of that was utilization?

這很有幫助。520萬美元。您能談談每週的進度嗎？然後是 95% 的診所轉換率，您是否知道其中的使用率是多少？

Look, because we're - I'll address the second question first. I think because we're shipping to a lot of these customers direct to clinic, which is why we're getting such good data on where it's going, I'd say we're not getting inventory on hand statements per se. But we are seeing repeat orders from similar clinics, so it gives us confidence that it's being utilized in the patients. I'm sorry, what was the first part of the question, Les?

看，因為我們 - 我將首先解決第二個問題。我認為，因為我們將許多客戶直接運送到診所，這就是為什麼我們能夠獲得有關其去向的良好數據，所以我想說我們本身並沒有獲得現有庫存報表。但我們看到類似診所的重複訂單，因此我們相信它正在被患者使用。抱歉，問題的第一部分是什麼，Les？

The weekly progression?

每週進度？

Weekly progressions. Slightly somewhat consistent, right? I'd say it's been fairly consistent. I think there was initial, I'll say, patient suite, right, patient identification that customers did, started moving patients on. So, I'm hopeful that we'll see, as we move through the end of this quarter, next quarter, another, let's say, patient suite where we adopt, or they look to convert additional patients.

每週進展。有點一致，對吧？我想說這是相當一致的。我認為最初的，我會說，患者套件，對，客戶所做的患者識別，開始轉移患者。因此，我希望，當我們在本季末、下個季度結束時，我們會看到我們採用的另一個患者套件，或者他們希望轉換更多患者。

It sounds like it's probably a good proxy, for how the rest of the quarter will line up.

聽起來這可能是一個很好的指標，可以預測本季剩餘時間的情況。

Yes. I hate to guide you that way, Les. Obviously, I said I don't have a crystal ball. I think Greg or Jason made ask the same thing. I feel good with the revenue run rate that we're seeing. I think that's how I'd describe it.

是的。我討厭這樣引導你，萊斯。顯然，我說我沒有水晶球。我認為格雷格或傑森問了同樣的事情。我對我們所看到的收入運行率感到滿意。我想這就是我的描述方式。

That's fair. Thanks Joe. And great detailed color on the pipeline. It's very helpful. Maybe a follow-up to that. It appears there's some costs involved. How do you intend to fund these studies, not much in terms of cost, but just maybe talk about the funding there. And then just quickly expect the time line on the TPN enrollment. And like, could we expect interim top line prior to '27, '28? Thank you.

這很公平。謝謝喬。管道上的顏色非常細緻。這非常有幫助。也許是後續行動。看來這涉及到一些成本。你打算如何資助這些研究，在成本方面不多，但也許只是談談那裡的資助。然後快速預計 TPN 註冊的時間軸。比如說，我們可以期待 27 年、28 年之前的中期營收嗎？謝謝。

Yes. So I'll let Liz get into the kind of the clinical time line in a second. But I think you're asking about its financing, Les. And I want to kind of comment on a couple of things, and make sure that we're clear. So, I continue to believe we don't need to do any type of, let's say, large dilutive financing at this time, right? We've got a revenue run rate that I feel pretty good about.

是的。因此，我將讓莉茲立即了解臨床時間線。但我認為你問的是它的融資問題，萊斯。我想對一些事情發表評論，並確保我們清楚。因此，我仍然認為我們目前不需要進行任何類型的大規模稀釋性融資，對嗎？我們的收入運行率我感覺非常好。

Just even five weeks into starting shipments that's offsetting a large amount of operating expenses. And I walked through with Jason kind of you've got these clinical budgets for the four programs relatively modest. And even if you overlay them right on top of each other at peak, I feel that with cash on hand, operating cash flow, we have the ability to fund these studies without any type of, call it, large financing.

開始發貨僅五週就抵消了大量營運費用。我和傑森一起了解了這四個項目的臨床預算相對適中。即使你在高峰期將它們疊加在一起，我覺得只要手頭有現金，運營現金流，我們就有能力為這些研究提供資金，而無需任何類型的大規模融資。

But that said, we do have the ATM facility in place, which gives us the ability to raise small amounts of money at the market price. We used a little bit of it last quarter when the stock price was up on some higher volume days. We could continue, to utilize the ATM to supplement our cash flow from operations, but that's currently how I'm thinking about the trajectory of the business and funding additional growth.

但話雖如此，我們確實擁有 ATM 設施，這使我們能夠以市場價格籌集少量資金。上個季度，當股價在成交量較高的日子裡上漲時，我們使用了一點它。我們可以繼續利用 ATM 來補充我們的營運現金流，但這就是我目前思考業務軌跡和為額外成長提供資金的方式。

And the time lines?

還有時間軸？

Liz, go ahead.

莉茲，繼續吧。

Sure. Yes. Thanks, Les. So the study is a Phase 3 study that has 12 months of intervention in it. We're looking forward to kicking it off as soon as we get feedback from FDA or clear that 30-day statutory hold. We have a lot of enthusiasm from TPN docs as this remains a very critical unmet need in this space.

當然。是的。謝謝，萊斯。所以這項研究是一項 3 期研究，有 12 個月的干預時間。我們期待在收到 FDA 的回饋或明確 30 天的法定保留後立即啟動該計劃。TPN 文件對我們充滿熱情，因為這仍然是該領域非常關鍵的未滿足需求。

So I don't want to overpromise for enrollment, but we feel pretty positive that we'll have up to 25 sites in the U.S. that are actively engaged and interested to participate. We don't have a planned interim analysis in terms of a readout, but I certainly expect that we'll see something before '28.

因此，我不想對註冊做出太多承諾，但我們非常樂觀地認為，我們在美國將有多達 25 個站點積極參與並有興趣參與。我們沒有計劃在讀數方面進行中期分析，但我當然希望我們會在 28 年前看到一些東西。

Great. Thank you

偉大的。謝謝

Yes.

是的。

John Juco with Needham & Company.

約翰‧朱科 (John Juco) 與李約瑟公司 (Needham & Company)。

Hi, good morning. This is John on for Serge today. Congrats on the initial launch report and thanks for taking our questions. And first, can you just touch on the process for DefenCath trial and adoption across the inpatient and outpatient segments? And any notable differences between those two processes? And then second, regarding the TDAPA reimbursement process that's in place, is this kind of a seamless and easily operating at this time? And is this something that most operators are familiar with?

嗨，早安。這是今天為 Serge 發言的約翰。恭喜最初的發布報告，並感謝您提出我們的問題。首先，您能否簡單介紹一下 DefenCath 在住院和門診領域的試驗和採用過程？這兩個過程之間有什麼顯著差異嗎？其次，關於現有的 TDAPA 報銷流程，目前是否無縫且易於操作？這是大多數運營商所熟悉的嗎？

Yes. I'll take the second question first, and then I'm going to pass the first question over to Liz. Look, in terms of TDAPA, I think I kind of hit on it before. It is a relatively new reimbursement mechanism in the last couple of years. I'd say a lot of the operators are familiar with it. But some for some, it's still new when it's requiring some education.

是的。我先回答第二個問題，然後我將第一個問題轉交給Liz。聽著，就 TDAPA 而言，我想我之前就想到過它。這是過去幾年相對較新的報銷機制。我想很多運營商都熟悉它。但對某些人來說，它仍然是新的，需要一些教育。

So all the systems are in place, right, for the government to process these claims. And so that's not an issue. It's just whether or not a dialysis operator has ever processed TDAPA reimbursement before, and needs a little bit of assistance in understanding, how to go about doing that. Now, Liz, go ahead in terms of inpatient versus outpatient kind of process.

因此，政府處理這些索賠的所有系統都已到位，對吧。所以這不是問題。這只是透析操作者之前是否曾經處理過 TDAPA 報銷，並且需要一些幫助來理解如何做。現在，莉茲，繼續討論住院與門診的流程。

Sure. Yes. So they definitely are different processes, right? So within an institution or a hospital setting, you've got a ton of varying factors here, right, system size, operations infrastructure, capacity to adapt internal demand for the product, which is what the field team is very focused on. They're looking at safety data, they're engaging with us. And then you've got to get to P&T, right?

當然。是的。所以它們肯定是不同的過程，對吧？因此，在機構或醫院環境中，這裡有大量不同的因素，對吧，系統規模、營運基礎設施、適應產品內部需求的能力，這是現場團隊非常關注的。他們正在查看安全數據，他們正在與我們互動。然後你必須去 P&T，對嗎？

And then after you get to P&T, if the product is approved, there is a process in terms of pulling it through, to build it out in your EMR, builds out your charge descriptions and master build, get the pharmacy up to speed with dispensing and stocking, right? So it can be really efficient in certain institutions, and it can take many, many months depending on the bureaucracy you're dealing with in an institution.

然後，在您到達 P&T 後，如果產品獲得批准，就會有一個過程，將其通過，在您的 EMR 中構建它，構建您的費用描述和主構建，讓藥房加快配藥速度還有襪子，對吧？因此，它在某些機構中可能非常有效，並且可能需要很多很多個月的時間，這取決於您在機構中處理的官僚機構。

On the outpatient side, right, it is very much driven by the physicians, but there is - it's an onerous and I would say, rigorous operational out-roll for the clinics to do, right? These are already sometimes understaffed, working really hard and you've got to do policies, procedures, protocols order sets to get everything up to speed to roll this out nationwide in a clinic or even a small center, right? So there's a lot of work that goes into it.

在門診方面，對吧，這在很大程度上是由醫生推動的，但對於診所來說，這是一項繁重的、我想說的、嚴格的操作，對嗎？這些機構有時已經人手不足，工作非常努力，您必須制定政策、程序、協議命令集，以使一切加快步伐，以便在全國範圍內的診所甚至小型中心推廣這項技術，對嗎？因此，需要做很多工作。

I think the uptake on an outpatient side can be a little bit faster for sure, especially when you're looking at a small or medium-sized deal. But these are not overnight processes, and it takes a lot of time. They've got to train all of their staff, and we're a new innovative product, right?

我認為門診方面的吸收肯定會更快一點，特別是當您考慮中小型交易時。但這些都不是一朝一夕的過程，需要花費很多時間。他們必須培訓所有員工，而我們是一個新的創新產品，對吧？

So there's a lot of education that goes into it as well. So I would say from an expectation standpoint, I would say it that inpatient is going to take longer to adopt and pull through.

所以這裡面也有很多教育內容。所以我想說，從期望的角度來看，住院患者將需要更長的時間才能接受並度過難關。

And on the outpatient side, we're hoping for much faster adoption, and that's what the field team is focused on, on educating our clients and customers for.

在門診方面，我們希望能夠更快地採用，這就是現場團隊的重點，即對我們的客戶和消費者進行教育。

Thanks Liz. Great. Thanks for the color

謝謝莉茲。偉大的。謝謝你的顏色

Thanks, John

謝謝，約翰

Thank you. And now I'd like to turn the floor to Daniel Ferry, who will facilitate written questions, which have been submitted.

謝謝。現在我想請丹尼爾費裡 (Daniel Ferry) 發言，他將協助提出已提交的書面問題。

Thank you, operator. Joe, we have a few written questions from the audience. How is the contract going with the previously announced top-tier midsized dialysis provider? Can you provide us any color on this contract's contribution to sales? And can you disclose who it is?

謝謝你，接線生。喬，我們有一些觀眾提出的書面問題。與先前宣布的頂級中型透析提供者的合約進度如何？您能否向我們提供有關該合約對銷售貢獻的任何資訊？能透露一下是誰嗎？

Okay. Thanks, Dan. So I guess I'll start by saying I couldn't be happier with the relationship or what we're seeing from a kind of patient and product uptake standpoint. We don't intend to provide any kind of customer-specific sales breakdown at this time. But I will say, as the largest of our customers in terms of clinics, they're also currently the largest in terms of DefenCath utilization.

好的。謝謝，丹。因此，我想我首先要說的是，我對這種關係或從患者和產品採用的角度所看到的情況感到非常滿意。目前我們不打算提供任何特定於客戶的銷售明細。但我要說的是，作為我們最大的診所客戶，他們目前也是 DefenCath 使用率最大的客戶。

So they are a big driver behind our initial uptake, but we do certainly have material sales to other kind of smaller to midsize customers as well. On the publicity front, I would say that they're a privately held organization that has asked us for the time being to not utilize their name and publications and focus on implementation and execution.

因此，他們是我們最初採用的重要推動力，但我們當然也向其他中小型客戶進行了材料銷售。在宣傳方面，我想說，他們是一個私人組織，要求我們暫時不要使用他們的名字和出版物，而是專注於實施和執行。

So to that extent, we're respecting the request of our currently largest customer and focused on building the business. As I mentioned, we do have other - a couple of other small dialysis organizations that are under contract that we didn't separately announce for similar reasons. So, we're happy with those relationships as well.

因此，從這個意義上說，我們尊重目前最大客戶的要求，並專注於發展業務。正如我所提到的，我們確實還有其他一些簽約的小型透析組織，出於類似的原因，我們沒有單獨宣布這些組織。所以，我們對這些關係也很滿意。

Okay. Great. Another one here. You commented today about Medicare Advantage being a sizable and growing group of Medicare patients. Can you explain how, is this different from traditional Medicare for DefenCath? Also, how is it reimbursed - reimbursement handle today if a dialysis provider uses DefenCath in a Medicare Advantage patient? And a follow-up here, what did you mean that United expects to provide comparable TDAPA reimbursement? And will they always provide that?

好的。偉大的。這裡還有另一張。您今天評論說 Medicare Advantage 是一個規模龐大且不斷增長的 Medicare 患者群體。您能否解釋一下，這與傳統的 DefenCath 醫療保險有何不同？另外，如果透析提供者在 Medicare Advantage 患者中使用 DefenCath，如何報銷 - 今天的報銷處理？後續問題是，您所說的美聯航希望提供類似的 TDAPA 報銷是什麼意思？他們總是會提供這些嗎？

Okay. Thanks, Dan. I'm sure that was a lot for you to consolidate. I'm going to try and break them down into pieces. So I guess, first, Medicare Advantage in relation to traditional Medicare, it's essentially, right, it's a privatization of Medicare, where managed care providers like United, Humana, they assume risk for all costs associated with a Medicare patient in exchange for premiums and a fixed amount from the government.

好的。謝謝，丹。我相信這對你來說需要鞏固很多。我將嘗試將它們分解成碎片。所以我想，首先，相對於傳統醫療保險，醫療保險優勢本質上是醫療保險的私有化，像United、Humana 這樣的管理醫療服務提供者承擔與醫療保險患者相關的所有費用的風險，以換取保費和政府提供的固定金額。

The MA plan then essentially controls drug formulary and kind of manages treatment similar to private commercial insurance. So they're the ones that are on the hook for all the costs and the risk. Now with the TDAPA, historically, whether or not the MA plan paid at TDAPA, would depend on what agreement was in place, between the provider and that MA plan, and whether or not there were new innovations covered under that agreement.

MA 計劃基本上控制藥物處方，並管理類似於私人商業保險的治療。因此，他們是承擔所有成本和風險的人。現在有了 TDAPA，從歷史上看，MA 計劃是否在 TDAPA 支付，將取決於提供者和 MA 計劃之間簽訂的協議，以及該協議是否涵蓋新的創新。

Which was why we're happy that United has communicated a willingness to pay TDAPA for DefenCath beginning on September 1. We think that's incredibly meaningful. Now in terms of, I guess, how those payments may track or change over time. I think that's the primary reason why we want to run this real-world evidence study and our biggest opportunity from a reimbursement standpoint.

這就是為什麼我們很高興曼聯表示願意從 9 月 1 日開始為 DefenCath 支付 TDAPA。我們認為這非常有意義。現在，我想，這些付款如何隨著時間的推移進行追蹤或變化。我認為這是我們想要進行這項現實世界證據研究的主要原因，也是從報銷的角度來看我們最大的機會。

So since the MA plans, as I said, are on the hook for all of these medical costs for the patients. They're the ones that are going to bear the brunt of the downstream costs associated with getting a CRBSI. So, if you think about it as if CRBSI can cost upwards of $60,000 a year, and then you add other downstream costs that gets over can get over $100,000.

因此，正如我所說，MA 計劃要承擔患者的所有這些醫療費用。他們將首當其沖地承受與獲得 CRBSI 相關的下游成本。因此，如果您考慮 CRBSI 每年的成本可能高達 60,000 美元，然後再加上其他下游成本，超過的成本可能會超過 100,000 美元。

We've really seen opportunity here to generate real-world data during the TDAPA period, and hope to utilize it to negotiate, let's say, longer term more sustainable reimbursement with the MA plans. And from a macro level, we expect the majority of ESRD patients to be shifting into these MA plans over the next five years.

我們確實看到了在 TDAPA 期間產生真實世界數據的機會，並希望利用它來與 MA 計劃進行更長期、更永續的報銷談判。從宏觀層面來看，我們預期大多數 ESRD 患者將在未來五年內轉入這些 MA 計畫。

Great. Thanks, Joe. Operator, this concludes the question-and-answer session. You may now close the call.

偉大的。謝謝，喬。接線員，問答環節到此結束。您現在可以結束通話了。

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

謝謝。會議現已結束。感謝您參加今天的演講。現在您可以斷開線路。