CorMedix Inc (CRMD) 2024 Q3 法說會逐字稿

完整原文

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  • Operator

    Operator

  • Good day and welcome to the CorMedix Inc third quarter, 2024 financial results conference call (Operator Instructions). I would now like to turn the conference over to Dan Ferry of lifestyle advisers. Please go ahead.

    美好的一天,歡迎參加 CorMedix Inc 2024 年第三季財務業績電話會議(操作員說明)。我現在想把會議交給生活風格顧問 Dan Ferry。請繼續。

  • Dan Ferry - IR Contact Officer

    Dan Ferry - IR Contact Officer

  • Thanks operator. Good morning and welcome to the CorMedix third quarter, 2024 earnings conference call leading the call today is Joe Tedisco, Chief Executive Officer of for CorMedix and he is joined by Dr Matt David, Executive Vice President and CFO Beth Zelma Kaufman VP and Chief Legal Officer, Liz Hurlbert, EVP and Chief Clinical Strategy and Operations Officer and Erin M EVP and Chief Commercial Officer.

    感謝運營商。早安,歡迎參加CorMedix 2024 年第三季財報電話會議,今天主持電話會議的是CorMedix 執行長Joe Tedisco,執行副總裁兼財務長Matt David 博士也參加了此次電話會議,貝絲·澤考夫曼(Beth Zelma Kaufman) 副總裁兼首席法律官、Liz Hurlbert,執行副總裁兼首席臨床策略和營運長以及 Erin M 執行副總裁兼商務長。

  • 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.

    在我們開始之前,我想提醒大家,在電話會議期間,管理階層可能會在會議中做出 1995 年《私人證券訴訟改革法案》中規定的所謂前瞻性陳述。

  • 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 action 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 describing in greater detail in CORS filings with the SEC which are available free of charge at the SECs website or upon request from CORS Cosmetics may not actually achieve the goals or plans describing in these forward-looking statements and investors should not place undue reliance on these statements.

    這些陳述不是關於管理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,由於各種重要因素,行動結果可能與這些陳述所依據的估計和預測存在重大差異包括向SEC提交的CORS 文件中更詳細描述的風險和不確定性,這些文件可在SEC 網站上免費獲取或應CORS Cosmetics 的要求而實際上可能無法實現這些前瞻性聲明中描述的目標或計劃,投資者不應這樣做過度依賴這些陳述。

  • Cosmetics does not intend to update these forward-looking statements except as required by law at this time. It is now my pleasure to turn the call over to Joe Disco, Chief Executive Officer of CorMedix. Joe. Please go ahead.

    除目前法律要求外,Cosmetics 不打算更新這些前瞻性聲明。現在我很高興將電話轉給 CorMedix 執行長 Joe Disco。喬.請繼續。

  • Joseph Todisco - Chief Executive Officer, Director

    Joseph Todisco - Chief Executive Officer, Director

  • Thanks Jim, good morning everyone and thank you for joining the call as we approach the end of our first calendar year of commercial launch of DefenCath.

    謝謝吉姆,大家早安,感謝您在 DefenCath 商業推出的第一個日曆年即將結束之際加入我們的電話會議。

  • I'm incredibly proud of the team's efforts and pleased with the commercial results. Thus far, the third quarter marks the first full quarter of product shipment for FCAS as well as the first quarter of outpatient product utilization.

    我對團隊的努力感到無比自豪,並對商業成果感到滿意。到目前為止,第三季度是 FCAS 產品出貨量的第一個完整季度,也是門診產品使用量的第一個季度。

  • Our net revenue for the third quarter of $11.5 million exceeded street consensus and was largely driven by our initial anchor customer, Us Renal, which has done an exceptional job with the FCAS implementation within its clinics.

    我們第三季的淨收入為 1,150 萬美元,超出了市場共識,這主要是由我們最初的主要客戶 Us Renal 推動的,該客戶在其診所內實施 FCAS 方面表現出色。

  • We recently announced new agreements with two midsized dialysis operators and one large scale operator which combined with our existing customers will provide patients access to FCAS and roughly 60% of dialysis clinics in the US.

    我們最近宣布與兩家中型透析業者和一家大型透析業者達成新協議,與我們現有的客戶結合,將為患者提供 FCAS 和美國約 60% 的透析診所的服務。

  • We are currently working diligently with our new partners to operationalize those agreements and currently expect purchases to commence for all three before the end of the fourth quarter.

    我們目前正在與新合作夥伴努力合作,落實這些協議,目前預計這三個項目的採購將在第四季末之前開始。

  • While we have not issued revenue guidance for the fourth quarter, based upon our current forecast, we do expect to be positive for the fourth quarter.

    雖然我們尚未發布第四季度的收入指引,但根據我們目前的預測,我們預計第四季度的收入將是正面的。

  • With respect to guidance, there was a wide potential variability for fourth quarter revenue driven by the timing and scale of purchases by our LDO customer as well as the scale of purchases by our newly announced midsize customers. DefenCath for the most part is being protocolized by the outpatient customers that adopt the product, meaning they are establishing criteria for patients in their system for which DefenCath is appropriate and then implementing protocols based on those criteria.

    就指導而言,由於我們的 LDO 客戶的採購時間和規模以及我們新宣布的中型客戶的採購規模,第四季度收入存在很大的潛在變化。DefenCath 大部分是由採用該產品的門診客戶制定協議,這意味著他們正在為系統中適合 DefenCath 的患者制定標準,然後根據這些標準實施協議。

  • This requires a significant pre implementation effort with each customer to establish protocols, order sets and conduct training on an enterprise level. And in the case of our LDO, customer requires implementation on a much larger scale to allow a rollout at over 2000 clinics.

    這需要與每位客戶進行大量的預實施工作,以建立協議、訂單集並在企業層級進行培訓。就我們的 LDO 而言,客戶需要更大規模的實施,以便在 2000 多家診所進行推廣。

  • The upside of having our drug protocolized in this manner is that once a customer goes live, we expect the patient conversion ramp to move fairly quickly.

    以這種方式製定藥物方案的好處是,一旦客戶上線,我們預計患者轉換率會相當快速地變化。

  • The downside is that set up can take anywhere from several weeks to a few months.

    缺點是設定可能需要幾週到幾個月的時間。

  • Currently, we are expecting our LDO customer to begin ordering in December but a couple of weeks' movement in either direction from a customer of this scale would obviously have a material impact on our fourth quarter revenue for our new (inaudible) customers. We expect orders to begin in November with respect to our inpatient launch activities. We have made significant progress in terms of building DefenCath champions within hospitals and health systems and scheduling meetings with those institutions.

    目前,我們預計 LDO 客戶將於 12 月開始訂購,但這種規模的客戶在任何一個方向上幾週的變動顯然都會對我們新(聽不清楚)客戶的第四季度收入產生重大影響。我們預計將於 11 月開始接受住院啟動活動的訂單。我們在醫院和衛生系統內培養 DefenCath 冠軍以及安排與這些機構的會議方面取得了重大進展。

  • A large number of P&T meetings occurred in the third quarter and we are in the process of fielding questions and providing additional information required for a formal decision.

    第三季舉行了大量的 P&T 會議,我們正在回答問題並提供正式決策所需的其他資訊。

  • The P&T committee discussions require both a comprehensive review and collaboration across multiple stakeholders including political and financial within the health system.

    P&T 委員會的討論需要多個利益相關者(包括衛生系統內的政治和財務利益相關者)進行全面審查和協作。

  • To that extent, we expect the inpatient uptake process to be longer and the ramp to be more consistent with traditional inpatient launches. In comparison to the more rapid uptake we have seen on the outpatient side, we have started to see some utilization in a handful of hospitals that have completed P&T review early and added the FCAS to formulary and we're optimistic to build on that progress in 2025 as we continue our field efforts with the FCA Advocates focusing now on 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 parental nutrition or TPM.

    從這個意義上來說,我們預計住院患者的接受過程會更長,並且增長速度將與傳統住院患者的啟動更加一致。與我們在門診方面看到的更快速的採用相比,我們已經開始看到少數幾家醫院已經開始使用,這些醫院已經提前完成了P&T 審查並將FCAS 添加到處方集中,我們對在這一進展的基礎上再接再厲感到樂觀。我們在第二季宣布,我們收到了 FDA 的支持性回饋,涉及我們提出的成人全腸外營養 (TPM) 臨床路徑。

  • Since then, we have received FDA feedback and conducted extensive market research and clinical feasibility studies. And accordingly, we are refining the clinical protocol and anticipate, submitting it to FDA by mid-November to align with our plans to operationalize the study in the first half of 2025.

    此後,我們收到了 FDA 的回饋,並進行了廣泛的市場研究和臨床可行性研究。因此,我們正在完善臨床方案,並預計在 11 月中旬之前將其提交給 FDA,以符合我們在 2025 年上半年實施研究的計劃。

  • The company's goal for TPN is to obtain FDA approval for an expanded use of our tool and heparin lock solution in the late 2027 to 2028 time frame. And we estimate annual peak sales potential in this syndication to be in the range of $150 million to $200 million.

    公司 TPN 的目標是獲得 FDA 批准,在 2027 年末至 2028 年的時間範圍內擴大使用我們的工具和肝素鎖解決方案。我們估計該聯合組織的年度高峰銷售潛力將在 1.5 億至 2 億美元之間。

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

    從臨床預算的角度來看,我們將向投資者提供最新進展情況,我們預計研究的成本將在 1,000 至 1,200 萬美元之間,其中大部分費用跨越 2025 年和 2026 年。

  • During our previous earnings call, we also announced three additional clinical initiatives all expected to commence in the 2024 or early 2025 time frame.

    在先前的財報電話會議上,我們也宣布了另外三項臨床計劃,預計將於 2024 年或 2025 年初開始。

  • The most meaningful of the three from a data value standpoint is our real world evidence study that we will run in cooperation with our study partner, us renal care.

    從數據價值的角度來看,這三者中最有意義的是我們的現實世界證據研究,我們將與我們的研究合作夥伴美國腎臟護理公司合作進行。

  • Our hope with this study in which we expect to evaluate outcomes of roughly 2000 patients over 24 months at a cost of less than $1 million a year would be to generate real world evidence around the impact of DefenCath c utilization on cost of patient care, infection rates, hospitalization, mortality, and multiple other metrics such as lost chair time and antibiotic use.

    我們希望透過這項研究,以每年不到 100 萬美元的成本,在 24 個月內評估大約 2000 名患者的結果,從而產生關於 DefenCath c 使用對患者護理成本、感染成本的影響的真實世界證據。率、住院率、死亡率以及多種其他指標,例如失去就診時間和抗生素使用。

  • Ultimately, we would intend 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.

    最終,我們打算在適應後階段利用這些數據來協商 Medicare Advantage 計劃和其他基於價值的護理承包實體的未來可持續報銷。

  • Data collection for this study has already commenced simultaneously with our adult TPN and real world evidence studies. We will also be commencing a study in paediatric haemodialysis.

    這項研究的資料收集工作已經與我們的成人 TPN 和現實世界證據研究同時開始。我們也將開始一項兒科血液透析研究。

  • This will be a relatively small study spread over several years as we expect patient enrolment to be a challenge given an extremely small patient population and the need for very personalized protocols for these ultra vulnerable patients.

    這將是一項持續數年的相對較小的研究,因為我們預計,鑑於患者群體極小,並且需要針對這些極度脆弱的患者制定非常個性化的方案,因此患者入組將是一個挑戰。

  • This paediatric study is a post marketing requirement under the paediatric Research Equity Act by the FDA and we have FDAS concurrence on the final study protocol.

    這項兒科研究是 FDA 兒科研究公平法案下的上市後要求,我們已獲得 FDAS 對最終研究方案的同意。

  • We have plans to begin patient enrolment in early 2025 and we expect the study to cost between four and $6 million spread over five years.

    我們計劃於 2025 年初開始患者入組,預計研究在五年內花費 400 至 600 萬美元。

  • Lastly. In addition to our other clinical initiatives, we plan to commence an expanded access program for high risk populations including but not limited to paediatric TPM, peritoneal dialysis patients with refractory peritonitis and neutropenic oncology patients utilizing a CDC.

    最後。除了我們的其他臨床措施外,我們還計劃針對高風險族群啟動一項擴大准入計劃,包括但不限於兒科TPM、患有難治性腹膜炎的腹膜透析患者以及使用CDC 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.

    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。

  • The cost for the expanded access program 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 TPM program.

    擴大存取計劃的成本預計每年低於 750,000 美元,主要以免費產品和分銷成本的形式出現,我們希望產生支援進一步擴展標籤並補充我們的成人 TPM 計劃的數據。

  • Now I turn the call over to Matt to discuss the company's third quarter financial results and financial position that.

    現在我把電話轉給馬特,討論公司第三季的財務表現和財務狀況。

  • Matthew David - Chief Financial Officer, Executive Vice President

    Matthew David - Chief Financial Officer, Executive Vice President

  • Thanks Joe and good morning everyone. I am pleased to be here today to provide an overview of our third quarter, 2024 financial results. As well as an update on cosmetics' cash positions.

    謝謝喬,大家早安。我很高興今天能夠概述我們 2024 年第三季的財務表現。以及化妝品現金狀況的最新情況。

  • The company has filed its quarterly report on form 10 Q for the quarter ended September 30, 2024. I urge you to read the information contained in the report for a more complete discussion of our financial results with result with respect to our third quarter of 2024 financial results. Our net revenue for the third quarter of 2024 amounted to $11.5 million as Joe indicated. This marks the first full quarter since DefenCath became commercially available. This past spring, our net loss was approximately $2.8 million or 5¢ per share compared with a loss of $9.7 million or 17¢ per share in the third quarter of 2023.

    該公司已提交截至 2024 年 9 月 30 日的季度 10 Q 表格的季度報告。我敦促您閱讀報告中包含的信息,以便更完整地討論我們的財務業績以及 2024 年第三季財務業績的結果。正如 Joe 所說,我們 2024 年第三季的淨收入為 1,150 萬美元。這是自 DefenCath 投入商用以來的第一個完整季度。去年春天,我們的淨虧損約為 280 萬美元,即每股 5 美分,而 2023 年第三季的淨虧損為 970 萬美元,即每股 17 美分。

  • The smaller net loss recognized in 2024 compared with 2023 was driven by the gross profits associated with the net sales of the FCA operating expenses. In the third quarter of 2024 increased approximately 33% to $14.1 million compared with $10.5 million. In the third quarter of 2023.

    與 2023 年相比,2024 年確認的淨虧損較小,這是由於與 FCA 營運費用淨銷售相關的毛利所致。2024 年第三季度,這一數字從 1,050 萬美元增長了約 33%,達到 1,410 萬美元。2023年第三季。

  • The increase was driven by higher selling and marketing and G and a expenses offset by a decrease in R&D prometric is now reporting selling and marketing expense and general and administrative expense as separate line items on an apples to apples basis, selling and marketing expense increased 66% to 6.7 million in the third quarter of 2024. Compared with $4.1 million in the third quarter of 2023 G&A expense increased 76% to $6.6 million in the third quarter of 2024 versus $3.7 million in the third quarter of 2023.

    這一增長是由於銷售和營銷費用的增加以及研發費用的減少所抵消的,Prometric 現在將銷售和營銷費用以及一般和管理費用作為單獨的項目在同類基礎上報告,銷售和營銷費用增加了 66 2024年第三季成長% 至670 萬。與 2023 年第三季的 410 萬美元相比,2024 年第三季的一般管理費用增加了 76%,達到 660 萬美元,而 2023 年第三季為 370 萬美元。

  • The increase in selling 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 the FCA.

    銷售和行銷費用的增加主要歸因於行銷力度的增加和新人員的增加,包括我們的現場銷售組織以及對 FCA 商業發布的支援。

  • 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, R&D expense decreased by approximately 73% to $0.7 million. Driven by the approval of DefenCath as a result of the post FDA approval, commercial operations costs related to medical affairs and certain personnel expenses that supported R&D efforts. Prior to the FDA approval of defines CF have been recognized in selling and marketing or G & a expense.

    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先前作為研發組成部分支出的某些費用。在 FDA 批准之前,研發費用減少了約 73% 至 70 萬美元。在 FDA 批准後 DefenCath 獲得批准的推動下,與醫療事務相關的商業營運成本以及某些支援研發工作的人員費用。在 FDA 批准之前,定義 CF 已在銷售和行銷或 G & a 費用中確認。

  • In addition, a portion of the costs related to the manufacturing of the FCA previously recognized in R&D are now capitalized as a result of the FDA approval with respect to our nine month year-to-date 2024 financial results total net revenue during the nine month year-to-date of 2024 amounted to $12.3 million total operating expenses during nine month. Year-to-date of 2024 amounted to $45.5 million compared with $33.3 million in the first nine months of 2023 an increase of 37% R&D expense decreased 80% to $2.2 million. Driven primarily by the approval of the FCA selling and marketing expense increased approximately 106% to $20.5 million compared with the first nine months of 2023 and G&A expense increased approximately 83% to $22.9 million compared with the comparable period in 2023.

    此外,由於 FDA 批准了我們 2024 年至今 9 個月的財務業績,先前在研發中確認的 FCA 製造相關成本的一部分現已資本化。2024 年年初至今,研發費用為 4,550 萬美元,與 2023 年前 9 個月的 3,330 萬美元相比,成長了 37%,研發費用減少了 80%,至 220 萬美元。主要受到FCA 批准的推動,與2023 年前9 個月相比,銷售和行銷費用增加了約106%,達到2050 萬美元,一般及行政費用與2023 年同期相比增加了約83%,達到2290萬美元。

  • The increases in selling and marketing and G&A were driven primarily by new personnel and costs to support the commercial launch of the FCA.

    銷售和行銷以及一般管理費用的成長主要是由支援 FCA 商業推出的新人員和成本所推動的。

  • We recorded net cash used in operations during the nine month year-to-date of 2024 of $45 million compared with net cash used in operations of $27.7 million in the same period in 2023.

    我們記錄的 2024 年至今 9 個月的營運中使用的現金淨額為 4,500 萬美元,而 2023 年同期營運中使用的現金淨額為 2,770 萬美元。

  • The increase is primarily driven by an increase in trade receivables and inventories offset by a smaller net increase of accrued expenses and accounts payable.

    這一增長主要是由於應收帳款和存貨的增加被應計費用和應付帳款的淨增加較小所抵消。

  • The company has cash and cash equivalents of $46 million as of September 30th 2024.

    截至2024年9月30日,該公司擁有現金及現金等價物4,600萬美元。

  • While we expect to begin to see cash collection from our accounts receivable. In Q4, our cash position was supplemented in Quarter three with approximately $12.4 million in net proceeds from ATM issuant.

    雖然我們預計將開始從應收帳款中看到現金收回。第四季度,我們的現金部位在第三季得到了來自 ATM 發行的約 1,240 萬美元淨收益的補充。

  • We believe our cash equivalents short term investments and projected future operating cash flow gives the company the ability to fund operations for at least 12 months.

    我們相信,我們的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。

  • Assuming we maintain our current trajectory of sales from existing outpatient accounts and the initial shipments to new accounts during Quarter four, we believe we can achieve positive EBITDA in the fourth quarter. I will now turn the call back to Joe for closing remarks.

    假設我們在第四季度保持現有門診客戶的當前銷售軌跡以及向新客戶的初始發貨,我們相信我們可以在第四季度實現正的 EBITDA。現在我將把電話轉回給喬,讓他發表結束語。

  • Joseph Todisco - Chief Executive Officer, Director

    Joseph Todisco - Chief Executive Officer, Director

  • Thanks, Matt CorMedix is executing well on our launch of DefenCath and focused on growing the business with existing customers as well as expanding utilization of new ones.

    謝謝,Matt CorMedix 在我們推出 DefenCath 時表現良好,並專注於發展現有客戶的業務以及擴大新客戶的利用。

  • We're also actively working to expand the label for DefenCath beyond haemodialysis and beginning to scout for commercial stage business development opportunities to expand our product portfolio beyond DefenCath.

    我們也積極致力於將 DefenCath 的標籤擴展到血液透析之外,並開始尋找商業階段的業務發展機會,以將我們的產品組合擴展到 DefenCath 之外。

  • I appreciate everyone's continued support CorMedix and I'm happy to take questions.

    我感謝大家對 CorMedix 的持續支持,我很樂意回答問題。

  • Operator

    Operator

  • We will now begin the question and answer session to ask a question. (Operator Instructions).

    我們現在開始問答環節來提問。(操作員說明)。

  • Our first question comes from Jason Butler with Samson J MP. Please go ahead.

    我們的第一個問題來自 Jason Butler 和 Samson J MP。請繼續。

  • Unidentified Participant

    Unidentified Participant

  • Hi Thanks for Taking the questions and congrats on the quarter. I guess just a couple for me. Can you speak to, you know, the use that you're seeing today to what extent is being driven by, you know, individual doctors or centres decision to use the product versus the, the overall institution already implementing sops.

    您好,感謝您提出問題並祝賀本季。我想對我來說只有幾個。您能談談您今天看到的使用在多大程度上是由個別醫生或中心決定使用該產品與整個機構已經實施標準作業規程所驅動的嗎?

  • Second question, you, you've laid out reimbursement dynamics before for the outpatient setting and including the split between Medicare fee for service and Medicare advantage. How do those broader population dynamics compare to what you are actually seeing during the launch?

    第二個問題,您之前已經列出了門診環境的報銷動態,包括醫療保險服務費用和醫療保險優勢之間的分配。這些更廣泛的人口動態與您在發布期間實際看到的情況相比如何?

  • And then just lastly for me, can you speak to what you think about the, the trend for expenses operating expenses in Quarter four? Thanks.

    最後,您能談談您對第四季營運費用支出趨勢的看法嗎?謝謝。

  • Joseph Todisco - Chief Executive Officer, Director

    Joseph Todisco - Chief Executive Officer, Director

  • Okay. All right, thanks, Jason. I appreciate the question. So, what, what I think we have seen most or entirely with the initial rollout has been a protocolization of the product, meaning it is more of a top-down driven approach in the outpatient setting. I do not, we do not see as much of this being driven on a patient by patient or doctor specific basis, right. So, the centres are putting protocols in place. They're setting, they're establishing criteria within their systems for whom DefenCath is appropriate and then they are implementing based on that criteria and as I mentioned in the script specifically with respect to, you know, our, LDO customer, which we expect to follow the same pattern, right? The downside is that set up takes a couple of extra weeks leading in. But the upside is we expect patient conversion to move fairly quickly, right?

    好的。好的,謝謝,傑森。我很欣賞這個問題。所以,我認為我們在最初的推出中看到的最多或全部是產品的協議化,這意味著它在門診環境中更像是一種自上而下驅動的方法。我不認為,我們不認為這在很大程度上是由患者或醫生的特定基礎驅動的,對吧。因此,這些中心正在製定協議。他們正在製定,他們正在系統內建立 DefenCath 適合的標準,然後他們根據該標準進行實施,正如我在腳本中特別提到的,您知道,我們的 LDO 客戶,我們期望這一點遵循相同的模式,對吧?缺點是設定需要額外幾週的時間。但好的一面是我們預期患者的轉換速度會相當快,對嗎?

  • We expect to see a similar type of ramp to what we saw with our initial rollout with (inaudible). So overall we view that as a as a positive. Now, your question on reimbursement, I just want to make sure I understand you were asking about what we are actually seeing in claims. Is that.

    我們預計會看到與我們最初推出時看到的類似的斜坡類型(聽不清楚)。因此,總的來說,我們認為這是積極的。現在,關於報銷的問題,我只是想確保我明白您正在詢問我們在索賠中實際看到的內容。是這樣嗎。

  • Unidentified Participant

    Unidentified Participant

  • Exactly are you seeing that, that that roughly similar balance between fee for service and the Met advantage?

    您是否確實看到了服務費用和大都會優勢之間大致相似的平衡?

  • Joseph Todisco - Chief Executive Officer, Director

    Joseph Todisco - Chief Executive Officer, Director

  • Yeah. Well, the claims data lags. So, what we have seen with our initial customer roll out, I think is patients or, the facilities rather and fee for service patients first, right? And then expanding use into other payers. So, we are seeing claims that are being filed with Medicare Advantage with commercial with Medicaid. So, we are seeing I would say a broad dispersion of claims. I would say overall though, in terms of you just look at the aggregate number of patients that are, that are getting DefenCath. It is, it is, I believe it is starting in the fee for service patients first and then expanding outward.

    是的。嗯,索賠數據滯後。那麼,我們在最初的客戶推出中所看到的,我認為首先是患者,或者是設施,而不是服務患者的費用,對嗎?然後將用途擴展到其他付款人。因此,我們看到向 Medicare Advantage 提交的索賠以及向 Medicaid 的商業申請。因此,我們看到了各種主張的廣泛分散。不過,我想說的是,總體而言,只要看看正在接受 DefenCath 的患者總數即可。是是是,我相信首先是從服務病人的費用開始,然後向外擴展。

  • And your third question, Jason, I apologize was just, how should we think about expenses? (multiple speakers)

    傑森,你的第三個問題,我很抱歉,我們該如何考慮費用?(多個發言者)

  • Look for, the fourth quarter, I think, you know, we have guided to the year that 15 to 18 by quarter, we have been on the low end of that range. We are below the range for this quarter. You know, I think we will be somewhere in the 15 to 17 range for the fourth quarter is what I would expect.

    看看第四季度,我認為,你知道,我們已經將今年 15 到 18 個季度的業績指引到了,我們一直處於該範圍的低端。我們低於本季的範圍。你知道,我認為第四季度我們的銷量將在 15 到 17 之間,這是我所期望的。

  • Matt is that I just want to verify that with Matt. That's.

    馬特是我只是想和馬特確認這一點。就是這樣。

  • Matthew David - Chief Financial Officer, Executive Vice President

    Matthew David - Chief Financial Officer, Executive Vice President

  • Yeah, I think that is probably a fair job. We said that people were going to be, you know, begin to see things start up tick related to R&D, but it’s, really the 2025, 2026.

    是的,我認為這可能是一份公平的工作。我們說過,人們將開始看到與研發相關的事情開始發生,但實際上是 2025 年、2026 年。

  • Joseph Todisco - Chief Executive Officer, Director

    Joseph Todisco - Chief Executive Officer, Director

  • Yeah, that's a Quarter one.

    是的,那是四分之一。

  • Operator

    Operator

  • The next question comes from Gregory Renza with RBC capital. Please go ahead.

    下一個問題來自加拿大皇家銀行資本的格雷戈里·倫扎(Gregory Renza)。請繼續。

  • Gregory Renza - Analyst

    Gregory Renza - Analyst

  • Thanks. Good morning, Joe, and team. Congratulations on the progress and thanks for taking my questions. Yes, great, great to see the setup for the long-term Joe. And of course, as there is always interest in the fourth quarter and nearer term, we certainly appreciate all the uncertainties and the drivers, but just on the pushes and polls. Can you just remind us of just a few items when it comes to the stocking of DefenCath facilities, the holding time, and the order frequency, just how to think about that. And maybe on another topic related just when we think about the fourth quarter, how would we anticipate maybe some of the climate, the hurricanes or given? You are certainly southeast based focus for sure, with facilities, just any drivers on sort of the macro as it affects, getting gas to facilities to patients.

    謝謝。早上好,喬和團隊。恭喜您的進展,並感謝您提出我的問題。是的,太棒了,很高興看到長期喬的安排。當然,由於人們總是對第四季度和近期的情況感興趣,我們當然欣賞所有的不確定性和驅動因素,但只是推動和民意調查。您能否提醒我們一些關於 DefenCath 設施的庫存、持有時間和訂單頻率的事項,以及如何考慮這些問題。也許在另一個與我們思考第四季相關的話題上,我們將如何預測某些氣候、颶風或給定的情況?您肯定是東南部的焦點,有設施,任何宏觀影響的驅動因素,將天然氣輸送到設施和患者。

  • Joseph Todisco - Chief Executive Officer, Director

    Joseph Todisco - Chief Executive Officer, Director

  • No, thanks Greg. That is a good question. So, you know, for the, for the initial customer, that we have rolled out, we have been shipping direct to clinic and, to that extent, we are not seeing a lot of stocking. I think the estimates we are getting, maybe they are holding about 10 days on hand. You know, as we onboard our LDO customer, we do think there will be some stocking that they may hold 15 days to 30 days of inventory on hand. So, it will be a little bit more of a call, maybe a traditional turnover of inventory. You know, for the fourth quarter, we, did see a little bit of impact our initial customers. And one of the new MDO customers that, are deployed through the Southeast have a lot of clinics down there. So, we saw a little bit of disruption over the first, you know, week of the month but largely back, the trend we are seeing is largely back to, what we had when we exited Quarter three. So we're focused now on onboarding new customers and trying to build, you know, build out as well.

    不,謝謝格雷格。這是一個好問題。所以,你知道,對於我們已經推出的最初的客戶,我們一直直接運送到診所,從這個意義上說,我們沒有看到大量的庫存。我認為根據我們得到的估計,他們手頭上的庫存可能大約有 10 天。您知道,當我們接納 LDO 客戶時,我們確實認為會有一些庫存,他們手邊可能有 15 天到 30 天的庫存。因此,這將更像是一次電話會議,也許是傳統的庫存週轉。你知道,在第四季度,我們確實看到了我們最初的客戶受到了一些影響。部署在東南部的新 MDO 客戶之一在那裡擁有很多診所。因此,我們在本月的第一周看到了一些幹擾,但基本上又回來了,我們看到的趨勢很大程度上回到了我們退出第三季度時的情況。因此,我們現在的重點是吸引新客戶,並努力建立,你知道,擴大。

  • Gregory Renza - Analyst

    Gregory Renza - Analyst

  • That's helpful and maybe just on the manufacturing and API can just remind us of what you're doing just to ensure you've got, you know, the, the sufficient quantities for future demand. Thanks again and congrats.

    這很有幫助,也許僅在製造和 API 方面就可以提醒我們您正在做什麼,以確保您擁有足夠的數量來滿足未來的需求。再次感謝並恭喜。

  • Joseph Todisco - Chief Executive Officer, Director

    Joseph Todisco - Chief Executive Officer, Director

  • Well, first, I, I'd say that we have a, we have more than sufficient finished dose inventory on hand today to take us through a decent part of next year. So, from finished dosage in inventory standpoint, I think we are, we are in a really good position. We have also stockpiled a large amount of, of both of our, our key active ingredients and we are, we are I intend to purchase more in 2025 kind of to shore that up. We have two finished dosage manufacturers as well. We have, we have Rovi in Spain, and we have six regions, Germany.

    好吧,首先,我想說,我們今天手頭上有足夠的成品劑量庫存,可以讓我們度過明年的大部分時間。因此,從庫存的角度來看,我認為我們處於非常有利的位置。我們也儲備了大量的關鍵活性成分,我們打算在 2025 年購買更多,以支撐這一點。我們還有兩家成品製劑製造商。我們有,我們在西班牙有Rovi,我們有六個地區,德國。

  • Operator

    Operator

  • The next question comes from Brandon folks with Rodman Renshaw. Please go ahead, friends and your line may be muted.

    下一個問題來自布蘭登和羅德曼·倫肖的朋友。朋友們,請繼續,您的線路可能會被靜音。

  • Unidentified Participant 1

    Unidentified Participant 1

  • Hello. Can you hear me?

    你好。你聽得到我嗎?

  • Joseph Todisco - Chief Executive Officer, Director

    Joseph Todisco - Chief Executive Officer, Director

  • Can you hear me?

    你聽得到我嗎?

  • Unidentified Participant 1

    Unidentified Participant 1

  • Let me start again, apologies about that. Well, congrats on the quarter, first and foremost and thanks for taking my questions. Just two questions from me. Firstly, just in terms of patient types that the different providers have, the midsized operators identified the patient types that were initially used in CF with how much consistency are you seeing across the providers in terms of where they're expecting to use DefenCath?

    讓我重新開始,對此表示歉意。好吧,首先祝賀本季度,感謝您回答我的問題。我只想問兩個問題。首先,就不同提供者擁有的患者類型而言,中型業者確定了最初在 CF 中使用的患者類型,您認為各提供者在他們期望在何處使用 DefenCath 方面有多少一致性?

  • And perhaps the other side of that, if you are seeing any variability, does that provide an opportunity to perhaps sort of cross so educate providers on where other providers are using DefenCath?

    也許另一方面,如果您看到任何變化,這是否提供了一個可能有點交叉的機會,以便教育提供者了解其他提供者在哪裡使用 DefenCath?

  • Joseph Todisco - Chief Executive Officer, Director

    Joseph Todisco - Chief Executive Officer, Director

  • Thanks Brandon. So, look, I think, you know, we have talked about this over the last couple of quarters that some customers are triaging their patients based on the benefits verification. Others are looking at it on a on a high-risk basis kind of first. And, and I think that that is, you know, certainly how they are doing it in the, in their respective institutions. So, I do not know that there's consistency across all customers uniformly, but I think your question about opportunity is that yes, it is absolutely an opportunity for growth, right? Beyond whichever initial kind of triage criteria, the customers have used. And we are certainly already in discussions with some of our customers that have identified patients that are high risk as to what is the next cohort? And, and how much more broadly can we implement beyond high risk?

    謝謝布蘭登。所以,你看,我想,你知道,我們在過去幾季已經討論過,有些客戶正在根據福利驗證對病人進行分類。其他人首先是在高風險的基礎上看待它。而且,我認為這就是他們在各自機構中所做的事情。所以,我不知道所有客戶是否一致,但我認為你關於機會的問題是,是的,這絕對是一個成長的機會,對嗎?除了客戶使用的任何一種初始分類標準之外。我們當然已經在與一些客戶進行討論,他們已經確定了下一個隊列的高風險患者是什麼?而且,除了高風險之外,我們還能在多大程度上實施?

  • Unidentified Participant 1

    Unidentified Participant 1

  • Great, thanks. And then secondly, from me, gross margin in the quarter looked extremely strong. How should we think about gross margin going forward given this was your first full quarter of DefenCath in the market. And then especially with, as you bring on these sort of larger contracts, just, you know, even if it's just directionally, how do we think about gross margin from here?

    太好了,謝謝。其次,在我看來,該季度的毛利率看起來非常強勁。鑑於這是 DefenCath 進入市場的第一個完整季度,我們應該如何考慮未來的毛利率。然後特別是當你簽訂這些更大的合約時,即使只是定向的,我們如何看待這裡的毛利率?

  • Joseph Todisco - Chief Executive Officer, Director

    Joseph Todisco - Chief Executive Officer, Director

  • Look, I think gross margins are going to remain high. I mean, the initial gross margins, you are seeing a lot of that inventory was, was expensive R&D. These batches were manufactured prior to some of them prior to getting approval. But that said the cost of goods sold currently relative to the to the net selling price. It is, a healthy gross margin that, that we would expect, you know, through 2025.

    看,我認為毛利率將保持在高點。我的意思是,最初的毛利率,你會看到很多庫存是昂貴的研發費用。這些批次是在其中一些批次獲得批准之前生產的。但這是指目前銷售的商品成本相對於淨售價。我們預計到 2025 年,毛利率將保持健康。

  • Unidentified Participant 1

    Unidentified Participant 1

  • Great. Thanks for taking my questions and congrats on all the progress.

    偉大的。感謝您提出我的問題並祝賀所有的進展。

  • Joseph Todisco - Chief Executive Officer, Director

    Joseph Todisco - Chief Executive Officer, Director

  • Thank you.

    謝謝。

  • Operator

    Operator

  • The next question comes from Les Suski with Truest Securities. Please go ahead.

    下一個問題來自 Truest Securities 的 Les Suski。請繼續。

  • Unidentified Participant 2

    Unidentified Participant 2

  • Good morning, guys. Thank you for taking my questions and congrats on the progress. Just to look at Quarter three, any sort of metrics you can provide whether it was a patient count or vial usage. And then second out of the 60% access to dialysis centres that you have provided. Do you have a sense of what percentage of that is utilized with the ted calf? And then how do you capture the rest of those patients within that pool? And then the second part to that question is, what is the strategy to capture the other 40% operators to get them on board and how concentrated is that share, and I have a follow up. Thank you.

    早安,夥計們。感謝您回答我的問題並祝賀我的進展。看看第三季度,您可以提供任何類型的指標,無論是患者數量還是藥瓶使用情況。然後在您提供的 60% 的透析中心訪問權中排名第二。您知道 ted 小牛使用了其中的百分比嗎?那麼你如何捕捉該池中的其餘患者呢?這個問題的第二部分是,吸引其他 40% 營運商的策略是什麼,讓他們加入進來,以及這個份額的集中度如何,我有一個後續行動。謝謝。

  • Joseph Todisco - Chief Executive Officer, Director

    Joseph Todisco - Chief Executive Officer, Director

  • Okay, thanks. So, I mean, last, in terms, of third quarter metrics, I think we have put out currently what we are comfortable putting out. You know, we can certainly revisit that as we move forward and whether we want to put out any patient numbers or, potentially unit information. But right now, I think we are just comfortable putting out our you know, our sales data.

    好的,謝謝。所以,我的意思是,最後,就第三季指標而言,我認為我們目前已經發布了我們願意發布的內容。你知道,隨著我們的進展,我們當然可以重新審視這一點,以及我們是否想要公佈任何患者人數或可能的單位資訊。但現在,我認為我們很樂意公佈我們的銷售數據。

  • So in terms of 60% access, right, that is measured based on the number of the total number of clinics where DefenCath could potentially be available, right? Relative to the total number of clinics in the US. Now, as you know, first, you know, DefenCath is indicated for patients with CDCs which are about 20% of dialysis patients overall. And, and what we are seeing varies by customers. Some customers, as I said, that are already implementing more broadly, it is probably a much higher percentage of their, of their overall catheterized population. The initial LDO customer which we have talked about in the past, looking to roll out with 4,000 patients would be about 10% of their catheterized population. And certainly, we are working with them to grow beyond just that initial cohort. So, that's there is, so there is a decent amount of I think upside opportunity potential as we move into 2025 across, all customers.

    因此,就 60% 的訪問率而言,對吧,這是根據可能提供 DefenCath 的診所總數來衡量的,對吧?相對於美國診所的總數。現在,如您所知,首先,您知道,DefenCath 適用於 CDC 患者,約佔透析患者總數的 20%。而且,我們所看到的情況因客戶而異。正如我所說,一些客戶已經在更廣泛地實施,這可能佔他們接受導管的總體人群的比例要高得多。我們過去討論過的最初 LDO 客戶希望向 4,000 名患者推出該服務,該客戶將佔其插管人群的 10% 左右。當然,我們正在與他們合作,以超越最初的群體。所以,我認為,當我們進入 2025 年時,所有客戶都存在大量的上行機會潛力。

  • Now you asked about the, the remaining 40% obviously that most of that is concentrated with, one other LDO, we've been engaged with them over the past year and a half. They took a wait and see approach at the launch. We are in the process of re-engaging with them. Now, generating some additional data that they, we think that they will find compelling and, hopefully, we can make some progress with them in the fourth quarter or into early next year. If not, I think we are, very comfortable. We have got a really good trajectory with the four of the top five dialysis providers in the US.

    現在你問到剩下的 40% 顯然大部分都集中在另一個 LDO 上,我們在過去一年半的時間裡一直在與他們合作。他們在記者會上採取了觀望態度。我們正在與他們重新接觸。現在,我們認為他們會發現一些額外的數據令人信服,希望我們能夠在第四季或明年初與他們取得一些進展。如果沒有,我想我們也很舒服。我們與美國排名前五的透析提供者中的四家有著非常良好的合作關係。

  • Unidentified Participant 2

    Unidentified Participant 2

  • Got it very helpful. Second portion to this, I guess is you can make, when can we expect some sort of a meaningful contribution from the inpatient side? And then you had a (inaudible) agreement is, is there is that has been triggered, I believe based on your 10 Q, what is the amount and when that will be paid out? Thank you.

    得到它非常有幫助。我想第二部分是你可以做的,我們什麼時候可以期待住院方面做出某種有意義的貢獻?然後你們有一個(聽不清楚)協議,我相信根據你們的 10 個問題,金額是多少以及何時支付?謝謝。

  • Joseph Todisco - Chief Executive Officer, Director

    Joseph Todisco - Chief Executive Officer, Director

  • All right, thanks. So I'll, I'll start with the, with the inpatient and I'll, I'll kick the ND partners over to Matt.

    好的,謝謝。所以我會,我會從住院病人開始,我會,我會將 ND 合作夥伴踢給馬特。

  • Look.

    看。

  • So, so in patient, if you look at the size of the opportunity right now, outpatient is about 90% of our of our volume opportunity and certainly it's got a much deeper ramp in terms of the ability to convert patients more quickly. So, that is certainly what is going to driving and we are going to drive you know, our material revenue. Certainly in the short term, well, when we think about inpatient contribution, we look at it much more as a long term potential revenue contributor, we see a lot of value in that segment as we've talked about over the last two years, we see potentially better price durability there, but, it's going to take a longer time to build share and penetration there. It is just the nature of the inpatient market. So, I have a long-term view there. I think we are very happy with the trajectory we have seen for sale on the outpatient side and then we are going to continue to plug away on the inpatient side. You know, building relationships and making progress.

    因此,就病人而言,如果你看看現在機會的大小,門診約占我們數量機會的 90%,當然,在更快地轉化病人的能力方面,門診病人的增長幅度要大得多。因此,這肯定會推動我們的物質收入成長。當然,在短期內,當我們考慮住院患者的貢獻時,我們更多地將其視為長期潛在的收入貢獻者,正如我們在過去兩年中所討論的那樣,我們看到了該領域的巨大價值,我們認為那裡的價格持久性可能會更好,但是,需要更長的時間才能在那裡建立份額和滲透率。這就是住院市場的本質。所以,我對此有長遠的看法。我認為我們對門診方面的銷售軌跡非常滿意,然後我們將繼續在住院方面努力。你知道,建立關係並取得進步。

  • Matt. Do you want to comment on (inaudible)?

    馬特。你想發表評論嗎(聽不清楚)?

  • Matthew David - Chief Financial Officer, Executive Vice President

    Matthew David - Chief Financial Officer, Executive Vice President

  • Yeah, sure, no problem. I will just mention real briefly, you know, earlier this year this year, the company determined it was probable that the net sales milestones related to this would be achieved. And so, as a result, we recorded a license intangible asset which is included in accrued expenses in the consolidated balance sheet. The milestones were met during the three-month period ended September 30th, 2024. So, this is something that you should probably see. We would expect over the coming year to be paid.

    是的,當然,沒問題。我只想簡單地提一下,你知道,今年早些時候,該公司確定很可能會實現與此相關的淨銷售里程碑。因此,我們記錄了一項許可無形資產,該資產包含在合併資產負債表的應計費用中。這些里程碑是在截至 2024 年 9 月 30 日的三個月內實現的。因此,您可能應該看到這一點。我們預計將在來年收到付款。

  • Unidentified Participant 2

    Unidentified Participant 2

  • Got it. Thank you, guys.

    知道了。謝謝你們,夥計們。

  • Operator

    Operator

  • The next question comes from serge the launcher with Needham and Co company. Please go ahead.

    下一個問題來自 Needham and Co 公司的 serge 發射器。請繼續。

  • Unidentified Participant 3

    Unidentified Participant 3

  • Hi, good morning and congrats on the quarter. A couple of questions around your anchor customer, US Renal Care. I guess the first one, just what percentage of Quarter three sales that they represent? And then secondly, it sounds like it has been a solid partnership so far. They've had, they've had a successful (inaudible) process, just curious if this customer operates differently and whether you can replicate this partnership with some of the other partners that you've enlisted over the third quarter.

    你好,早安,恭喜本季。關於您的主要客戶 US Renal Care 的幾個問題。我猜第一個,它們佔第三季銷售額的百分比是多少?其次,到目前為止,這聽起來像是一種牢固的合作關係。他們已經有一個成功的(聽不清楚)流程,只是好奇這個客戶的運作方式是否不同,以及您是否可以與您在第三季招募的其他一些合作夥伴複製這種合作夥伴關係。

  • Joseph Todisco - Chief Executive Officer, Director

    Joseph Todisco - Chief Executive Officer, Director

  • Thanks.

    謝謝。

  • Alright, thanks, Serge. So, yes, I think, and we put there might be some numbers in the queue around concentration of receivables. But yes, the US Renal accounted for an incredibly large percentage of, of third quarter sales more than 90%.

    好的,謝謝,塞爾吉。所以,是的,我認為,我們在應收帳款集中度方面可能存在一些數字。但是,是的,美國腎臟病佔第三季銷售額的比例非常大,超過 90%。

  • And I think in terms of trying to, to replicate, you know, how well a job they have done with implementation. Yes, that is certainly something that we are you know, trying to duplicate with, other customers, you know, particularly you know, our LDO customers. So, you know, we're, hopeful for that and you know, we're just going to keep executing over the next couple of months.

    我認為,在嘗試複製方面,你知道,他們在實施方面做得有多好。是的,這當然是我們試圖與其他客戶複製的東西,尤其是我們的 LDO 客戶。所以,你知道,我們對此充滿希望,而且你知道,我們將在接下來的幾個月繼續執行。

  • Unidentified Participant 3

    Unidentified Participant 3

  • Maybe one follows up to that currently reimbursed at, the (inaudible). I think it is going to transition to ASP sometime in the early part of 2025. Just curious what that transition will look like and whether it could impact ordering patterns.

    也許有人會跟進目前報銷的情況,(聽不清楚)。我認為它將在 2025 年初的某個時候過渡到 ASP。只是好奇這種轉變會是什麼樣子,以及它是否會影響訂購模式。

  • Joseph Todisco - Chief Executive Officer, Director

    Joseph Todisco - Chief Executive Officer, Director

  • I do not think it is expected to impact ordering patterns. So, this is something that is anticipated, and we have structured our agreements around the transition from WACC to ASP and, and we don’t expect ASP to erode that drastically initially. Right. So, yes, this is, this is somewhat, of a known commodity. I think government will publish ASP at some point in late November or early December. I understand for, Quarter one and, I don't think it's going to be something that's problematic.

    我認為這不會影響訂購模式。因此,這是預料之中的事情,我們已經圍繞從 WACC 到 ASP 的過渡制定了協議,我們不希望 ASP 最初會大幅削弱這一點。正確的。所以,是的,這在某種程度上是一種已知商品。我認為政府將在 11 月底或 12 月初的某個時候發布 ASP。我理解第一季度,我認為這不會成為問題。

  • Unidentified Participant 3

    Unidentified Participant 3

  • Thanks for taking my questions.

    感謝您回答我的問題。

  • Operator

    Operator

  • This concludes the audio portion of the Q&A session. I will now turn it over to Dan Ferry for written questions from the audience.

    問答環節的音訊部分到此結束。現在我將把它交給丹費裡,讓觀眾提出書面問題。

  • Dan Ferry - IR Contact Officer

    Dan Ferry - IR Contact Officer

  • Thank you operator. So, Joe, we have some written questions from the audience. The first one is why isn't the company providing guidance? Do you have a sense when it may be possible to provide guidance for investors and analysts alike?

    謝謝運營商。喬,我們收到了一些觀眾提出的書面問題。第一個是公司為什麼不提供指導?您是否知道何時可以為投資者和分析師等提供指導?

  • Joseph Todisco - Chief Executive Officer, Director

    Joseph Todisco - Chief Executive Officer, Director

  • Okay. Thanks then. So, look, I think I kind of touched on it in the script a little bit. You know, we have got so much variability around the timing of on boarding our, LDO customer and think about a customer of that scale and, if they, you know, begin purchasing December 1 versus December 15 versus November 15. There is a lot of variation there in what it could do for fourth quarter numbers. So, we did not feel comfortable putting out a range at this point in time as we move through the quarter. We can certainly, you know, reevaluate that decision and see and see what we are, you know, once we, have orders and see, you know, repetition, you know, what, what we are comfortable putting out there. But right now, I think, you know, we are, comfortable guiding that. We do expect to be positive, which is I think an incredible accomplishment in the first, you know, 6 to 9 months of a, product launch (inaudible).

    好的。那就謝謝了。所以,看,我想我在劇本中稍微觸及了這一點。你知道,我們的LDO 客戶的加入時間有很大的可變性,考慮一下這種規模的客戶,如果他們,你知道,開始購買的時間是12 月1 日、12 月15 日和11 月15 日。它對第四季數據的影響有很多變化。因此,當我們進入本季度時,我們不願意在這個時間點給出一個範圍。我們當然可以,你知道,重新評估這個決定,看看我們是什麼,你知道,一旦我們接到命令,看到,你知道,重複,你知道,什麼,我們可以放心地在那裡發布什麼。但現在,我想,你知道,我們可以輕鬆地引導這一點。我們確實希望能夠保持積極的態度,我認為這是產品發布後 6 到 9 個月內取得的令人難以置信的成就(聽不清楚)。

  • Dan Ferry - IR Contact Officer

    Dan Ferry - IR Contact Officer

  • All right, thanks Joe. Another one here. Could you expand a bit on TPN? What is the FDA feedback been to date and what drove the company to make protocol amendments?

    好的,謝謝喬。這裡還有另一張。能詳細介紹一下 TPN 嗎?迄今為止 FDA 的回饋是什麼?

  • Joseph Todisco - Chief Executive Officer, Director

    Joseph Todisco - Chief Executive Officer, Director

  • Yeah, I am going to turn that over to Liz in a moment. But you know, we are, excited about the TPN opportunity. You know, we put our protocol into, FDA. They provided some comments, I think essentially around the, the statistics and the calculations, but nothing really that is going to change, you know, our timelines or cost of the study. So, Liz, you want to go ahead?

    是的,我稍後會將其轉交給莉茲。但您知道,我們對 TPN 機會感到興奮。你知道,我們將我們的協議提交給 FDA。他們提供了一些評論,我認為主要圍繞統計數據和計算,但實際上不會改變我們的時間表或研究成本。那麼,莉茲,你想繼續嗎?

  • Elizabeth Masson Hurlburt - Executive Vice President, Head of Clinical and Medical Affairs

    Elizabeth Masson Hurlburt - Executive Vice President, Head of Clinical and Medical Affairs

  • Sure, thanks Joe. So, e exactly, we received pretty minor feedback, wholly statistical in nature on the TPN protocol. And we have absorbed that and integrated it into a new protocol amendment that is forthcoming. There is always really a fine line in protocol development, right? The need to address the critical unmet need of the patient population with a study that is designed to provide rigor and high clinical value and one that can be translated post approval and integrated into clinical practice in a meaningful way. So, I think I am confident now we have a deeply experienced clinical regulatory and biostats team in place to meet those needs. And we will be resubmitting that protocol amendment in the next couple of weeks.

    當然,謝謝喬。因此,確切地說,我們收到了相當小的回饋,本質上完全是關於 TPN 協議的統計回饋。我們已經吸收了這一點並將其整合到即將發布的新協議修正案中。協議開發總是有一條細線,對嗎?需要透過一項旨在提供嚴謹和高臨床價值的研究來解決患者群體未滿足的關鍵需求,並且該研究可以在批准後轉化並以有意義的方式融入臨床實踐。因此,我認為現在我們有信心我們擁有一支經驗豐富的臨床監管和生物統計團隊來滿足這些需求。我們將在接下來的幾週內重新提交該協議修正案。

  • Dan Ferry - IR Contact Officer

    Dan Ferry - IR Contact Officer

  • Okay, great.

    好的,太好了。

  • Thanks. Another one here, Joe. Can you share any feedback from the nephrology community regarding product use and practice since launch?

    謝謝。這裡還有另一位,喬。您能否分享腎臟病學社群自推出以來有關產品使用和實踐的任何回饋?

  • And has there been anything in there that surprised you?

    其中有沒有什麼讓你感到驚訝的事情?

  • Joseph Todisco - Chief Executive Officer, Director

    Joseph Todisco - Chief Executive Officer, Director

  • I do not know if there's anything that I've, I've found surprising. Obviously, I think some of the good things about that utilizing DefenCath, right? There is no change to the workflow. The clinical results are really, really easy to understand, but I think overall the feedback that we get is positive and continues to be overall positive. But I will, you know, Aaron and Liz are in the field on a day-to-day basis. So, I mean, if they want to add some comments.

    我不知道是否有什麼讓我感到驚訝的事情。顯然,我認為利用 DefenCath 有一些好處,對嗎?工作流程沒有改變。臨床結果真的非常容易理解,但我認為總的來說,我們得到的回饋是正面的,並且總體上仍然是正面的。但我會,你知道,亞倫和莉茲每天都在現場。所以,我的意思是,如果他們想添加一些評論。

  • Erin Mistry - Executive Vice President, Chief Commercial Officer

    Erin Mistry - Executive Vice President, Chief Commercial Officer

  • Yeah, I can, add from there.

    是的,我可以,從那裡添加。

  • Yeah, thanks. Thanks Joe. I think for the, from an implementation standpoint, we have seen very positive feedback from nurses, physicians, and patient advocates. On the, on the inpatient side, the coordination and complexity involves are obviously complex and takes time. But we have seen a crucial role being played by infectious disease in the infection prevention as well as quality community and guiding those processes across the inpatient setting.

    是的,謝謝。謝謝喬。我認為,從實施的角度來看,我們看到了護理師、醫生和病人倡議者的非常正面的回饋。另一方面,住院方面,涉及的協調性和複雜性顯然是複雜且耗時的。但我們已經看到傳染病在感染預防以及優質社區和指導整個住院環境中的這些過程中發揮著至關重要的作用。

  • Liz. Do you have anything else you want to add to that?

    莉茲。您還有什麼要補充的嗎?

  • Elizabeth Masson Hurlburt - Executive Vice President, Head of Clinical and Medical Affairs

    Elizabeth Masson Hurlburt - Executive Vice President, Head of Clinical and Medical Affairs

  • No, I think you, really covered it. I mean, I think we are just continually surprised to learn that despite all of these infection prevention efforts that are out there from a number of groups and a number of initiatives that CRBSIS are continuing to happen. And there is still a great need to educate and raise awareness around them and prevention around them. So, I think we have a plan for that. The team is actively addressing it and I think we have really solid stewards in our clinician community and nursing communities that have adopted DefenCath and are really working with us to further that awareness within institutions.

    不,我認為你確實涵蓋了它。我的意思是,我認為我們不斷地驚訝地發現,儘管許多團體和 CRBSIS 都在繼續進行這些感染預防工作,但 CRBSIS 仍在繼續進行。仍然非常需要對它們進行教育和提高認識以及預防措施。所以,我認為我們對此有一個計劃。團隊正在積極解決這個問題,我認為我們的臨床醫生社群和護理社群擁有非常可靠的管理者,他們已經採用了 DefenCath,並且正在與我們合作,以提高機構內的這種意識。

  • Operator

    Operator

  • Too.

    也。

  • Dan Ferry - IR Contact Officer

    Dan Ferry - IR Contact Officer

  • Excellent. Yes. Thanks Liz. Thanks Aaron, Joe one final one here.

    出色的。是的。謝謝莉茲。謝謝亞倫,喬,這是最後一篇。

  • Can you give some thoughts on how CorMedix is thinking about financing going forward?

    您能否談談 CorMedix 如何考慮未來的融資?

  • Joseph Todisco - Chief Executive Officer, Director

    Joseph Todisco - Chief Executive Officer, Director

  • Okay. Yes. And I, I think, you know, we didn't touch on in the script, we've talked about it in past earnings calls, you know, over the last quarter, you know, with the, higher volume and the appreciation of the stock, it made sense to use the AP ma little bit and we did that and we may continue to do that in a, in a limited basis. But with the trajectory that we, see for the business, obviously, I do not think we need to do, you know any type of raise from an operational cash flow standpoint, right? To fund the business, you know, the reasons why we and we may want to consider something in the future where we, are getting a lot of inbound interest from, large institutional investors, right? Long, only investors, the type of people that we may want in the stock that they cannot currently find liquidity on the market. You know, we also may want, you know, start looking at, building up a little bit of dry powder for business development, but , we don't have anything I say, you know, imminently planned, but those would be the, you know, the reasons why we might want to consider something, you know, down the road.

    好的。是的。我,我想,你知道,我們在劇本中沒有提及,我們在過去的財報電話會議中討論過它,你知道,在上個季度,你知道,隨著交易量的增加和升值,股票,稍微使用AP 是有意義的,我們這樣做了,我們可能會在有限的基礎上繼續這樣做。但根據我們看到的業務軌跡,顯然,我認為我們不需要這樣做,從營運現金流的角度來看,你知道任何類型的融資,對嗎?為了為業務提供資金,您知道,我們和我們可能希望在未來考慮一些事情的原因,即我們從大型機構投資者那裡獲得了大量的入境興趣,對吧?多頭,只有投資者,我們可能想買股票但目前在市場上找不到流動性的人。你知道,我們也可能想要,你知道,開始考慮,為業務發展積累一點乾粉,但是,我們沒有任何我說的,你知道,迫在眉睫的計劃,但這些就是,你知道,我們可能想要考慮一些事情的原因,你知道,未來的事。

  • Dan Ferry - IR Contact Officer

    Dan Ferry - IR Contact Officer

  • Okay, great.

    好的,太好了。

  • Thanks Joe. Operator may now close the call.

    謝謝喬。接線員現在可以結束通話。

  • Operator

    Operator

  • This concludes our question-and-answer session and the conference is now concluded. Thank you for attending today's presentation. You may now disconnect.

    我們的問答環節到此結束,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。