CorMedix Inc (CRMD) 2024 Q4 法說會逐字稿

Good day, and welcome to the CorMedix, Inc. fourth-quarter and full-year 2024 financial results conference call. (Operator Instructions) Please note today's event is being recorded.

大家好，歡迎參加 CorMedix, Inc. 2024 年第四季和全年財務業績電話會議。（操作員指示）請注意，今天的活動正在被記錄。

I would now like to turn the conference over to Dan Ferry with LifeSci Advisors. Please go ahead.

現在我想將會議交給 LifeSci Advisors 的 Dan Ferry。請繼續。

Good morning, and welcome to the CorMedix fourth-quarter and full-year 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 and Compliance Officer; Liz Hurlburt, EVP and Chief Clinical Strategy and Operations Officer; and Erin Mistry, EVP and Chief Commercial Officer.

早上好，歡迎參加 CorMedix 2024 年第四季和全年財報電話會議。今天主持電話會議的是 CorMedix 執行長 Joe Todisco；與他一同出席的還有執行副總裁兼財務長 Matt David 博士； Beth Zelnick Kaufman，執行副總裁兼首席法律與合規長； Liz Hurlburt，執行副總裁兼首席臨床策略和營運長；以及執行副總裁兼首席商務長 Erin Mistry。

Before we begin, I would like to remind everyone that during the call, management may make what are known as forward-looking statements within the 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，管理階層可能會做出《1995 年私人證券訴訟改革法案》所規定意義內的前瞻性陳述。這些陳述不是關於管理層對公司前景和未來財務狀況的期望、信念、目標和計劃的歷史事實陳述。

Actual results may differ materially from the estimates and projections on which these statements are based due to a variety of important factors, including the 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.

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

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

CorMedix 實際上可能無法實現這些前瞻性陳述中所述的目標或計劃。投資者不應過度依賴這些聲明。除非法律要求，否則 CorMedix 不打算更新這些前瞻性聲明。

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

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

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

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

Thank you, Dan. Good morning, everyone, and thank you for joining us on this call. Having completed our initial partial year of commercial launch of DefenCath, I'm incredibly proud of the team's efforts and pleased with the commercial results thus far.

謝謝你，丹。大家早安，感謝大家參加這次電話會議。在完成 DefenCath 商業發布的最初一年部分工作後，我為團隊的努力感到無比自豪，並對迄今為止的商業成果感到滿意。

The fourth quarter saw continued growth with both existing as well as new customers in the outpatient segment, which was the primary driver of our strong revenue and profit results for both Q4 and full-year 2024. Net revenue for the fourth quarter and full year were $31.2 million and $43.5 million, respectively, both of which exceeded Wall Street consensus prior to our preannouncement on January 7.

第四季度，門診部現有客戶和新客戶均持續成長，這是我們 2024 年第四季和全年強勁營收和利潤業績的主要驅動力。第四季和全年淨收入分別為 3,120 萬美元和 4,350 萬美元，均超過了我們 1 月 7 日預告之前的華爾街共識。

The fourth quarter was also the first profitable commercial quarter in the company's history with net income of $13.5 million and adjusted EBITDA of $15.3 million. Fourth-quarter results were driven by strong uptake amongst patients at US Renal Care, ramping implementation at our mid-sized customers, IRC and DCI, as well as utilization by other small outpatient dialysis customers.

第四季也是該公司歷史上第一個盈利的商業季度，淨收入為 1350 萬美元，調整後 EBITDA 為 1530 萬美元。第四季業績的推動因素包括 US Renal Care 患者的強勁採用、中型客戶 IRC 和 DCI 的推廣實施以及其他小型門診透析客戶的利用。

As we announced back in early January, we began the first quarter of 2025 with more than $25 million of purchase orders in hand from existing customers for first-quarter delivery. While we are not going to provide full-year revenue guidance at this time, we currently estimate that net revenue from existing purchasing customers for the first six months of 2025 should be in the range of $50 million to $60 million, with more than $33 million expected in the first quarter.

正如我們在 1 月初宣布的那樣，從 2025 年第一季開始，我們手頭上有來自現有客戶的價值超過 2500 萬美元的採購訂單，將於第一季交付。雖然我們目前不會提供全年收入指引，但我們目前估計，2025 年前六個月來自現有購買客戶的淨收入應在 5,000 萬美元至 6,000 萬美元之間，預計第一季將超過 3,300 萬美元。

DefenCath's net selling price has been fairly stable throughout the first three quarters of outpatient commercialization. However, we do expect to begin to see some net price erosion beginning in the second quarter of 2025.

在門診商業化的前三個季度中，DefenCath 的淨售價一直相當穩定。然而，我們確實預計從 2025 年第二季開始將出現一些淨價格下降。

With respect to patient growth opportunities, there is still some potential for new patients with existing outpatient customers. However, to a large extent, our ability to grow patient volume significantly in the back part of 2025 will be contingent upon the timing of purchasing and scale of implementation by our contracted large dialysis organization customer.

在患者成長機會方面，現有門診客戶對於新患者仍有一定潛力。然而，在很大程度上，我們能否在 2025 年後期大幅增加患者數量將取決於我們簽約的大型透析組織客戶的購買時間和實施規模。

Prior to year end, we met with our contracted LDO customer who communicated to CorMedix that the DefenCath implementation was pushed into 2025 due to operational resource constraints. Over the course of February and early March, we've had multiple meetings with this customer, provided significant requested information around resources available at CorMedix to assist with training and the implementation of DefenCath, and we remain hopeful the customer will begin ordering and commence utilization prior to mid-year.

年底前，我們與簽約的 LDO 客戶會面，該客戶告知 CorMedix，由於營運資源限制，DefenCath 實施將推遲到 2025 年。在二月和三月初期間，我們與該客戶舉行了多次會議，提供了有關 CorMedix 可用資源的重​​要信息，以協助培訓和實施 DefenCath，我們仍然希望客戶能夠在年中之前開始訂購併開始使用。

Turning to the in-patient segment, we have started to see utilization increase at a handful of larger hospitals, and we are hopeful to increase penetration as we move throughout 2025. Back in January, we announced a change to our inpatient commercialization strategy, whereby we reorganized our field team covering outpatient and in-patient customers.

談到住院部分，我們已經開始看到少數大型醫院的使用率提高，我們希望到 2025 年滲透率能有所提高。早在一月份，我們就宣布了住院商業化策略的改變，我們重組了覆蓋門診和住院客戶的現場團隊。

This process is now complete as we are partnering with Syneos Health to build a dedicated in-patient field team that is highly experienced in the hospital formulary process and the launch of first in class products in the setting of care. We also recently announced a partnership with WSI to provide marketing and promotional resources for DefenCath specifically to facilities operated by the Veterans Administration.

這個過程現已完成，因為我們正在與 Syneos Health 合作建立一支專門的住院現場團隊，該團隊在醫院處方流程和在護理環境中推出一流產品方面擁有豐富的經驗。我們最近也宣布與 WSI 合作，為 DefenCath 提供行銷和促銷資源，專門用於退伍軍人管理局營運的設施。

I am happy to announce that the new in-patient team is nearly fully staffed and is expected to be active in the field in the next four to five weeks. The team contracted through WSI has already commenced promotional activities to VA facilities.

我很高興地宣布，新的住院團隊基本上已經配備齊全，預計將在未來四到五週內投入工作。透過 WSI 簽約的團隊已經開始向 VA 設施進行推廣活動。

While we do not currently report in-patient sales as a separate segment, we do expect to see meaningful growth in this setting of care by the end of 2025, with an increased contribution to overall revenue and earnings in 2026 and beyond.

雖然我們目前沒有將住院銷售額作為單獨的部分進行報告，但我們預計到 2025 年底，這種護理環境將實現有意義的增長，並在 2026 年及以後對整體收入和收益的貢獻將會增加。

Focusing now on our clinical developments, we are in the process of beginning our Phase 3 clinical study for the reduction of central line-associated bloodstream infections or CLABSIs in patients receiving total parenteral nutrition or TPN through a central venous catheter. We began site selection in February and expect to begin patient enrollment for the study in the second quarter of this year.

目前，我們專注於臨床開發，正在開始進行 3 期臨床研究，旨在減少透過中心靜脈導管接受全腸外營養或 TPN 的患者的中心靜脈導管相關血流感染或 CLABSI。我們從二月開始選址，預計今年第二季開始招募病患參與研究。

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

正如我們之前所傳達的，這是一項針對不到 150 名患者進行的為期 12 個月的研究，我們的目標是在 2026 年底前完成研究並向 FDA 提交新藥申請。我們最近向 FDA 提交了針對該適應症的孤兒藥地位申請，正在等待 FDA 的資格認定。

The company's goal for TPN is to obtain FDA approval for an expanded use of our taurolidine and heparin catheter lock solution in the late 2027 to early 2028 timeframe, and we estimate annual peak sales potential in this indication to be in the range of $150 million to $200 million. We'll provide investors with updates on progress in this important area of unmet need as we move forward.

該公司對 TPN 的目標是在 2027 年底至 2028 年初獲得 FDA 批准擴大使用我們的牛磺羅定和肝素導管鎖定溶液，我們估計該適應症的年峰值銷售潛力在 1.5 億美元至 2 億美元之間。我們將向投資者提供這一重要未滿足需求領域的最新進展。

During our previous earnings call, we also discussed three additional clinical initiatives, all having either commenced in 2024 or expected to begin in 2025. The most meaningful of the three from a data value standpoint is our real-world evidence study, which we are running in cooperation with our study partner, US Renal Care.

在我們先前的收益電話會議上，我們還討論了另外三項臨床計劃，這些計劃要么於 2024 年開始，要么預計將於 2025 年開始。從資料價值的角度來看，三者中最有意義的是我們的真實世界證據研究，我們正在與我們的研究夥伴 US Renal Care 合作進行這項研究。

Our hope with this study, in which we expect to evaluate outcomes of more than 2,000 patients over 24 months, 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 chair time and CRBSI related antibiotic use. Data collection for this study has already commenced.

我們希望透過這項研究來評估 24 個月內超過 2,000 名患者的結果，以獲得關於 DefenCath 使用對患者護理成本、感染率、住院率、死亡率以及其他多項指標（如失去的椅位時間和 CRBSI 相關抗生素使用）的影響的真實證據。這項研究的資料收集已經開始。

In addition to our adult TPN and real-world evidence studies, we will also be commencing a study in pediatric hemodialysis in 2025. 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.

除了成人 TPN 和真實世界證據研究之外，我們還將在 2025 年開始兒科血液透析研究。這將是一項持續數年的相對較小的調查，因為我們預計患者入組將是一個挑戰，因為患者數量極少，而且需要為這些極度脆弱的患者制定非常個性化的治療方案。

This pediatric study is a post marketing requirement under the Pediatric Research Equity Act by the FDA, and we have FDA's concurrence on the final study protocol. We currently expect patient enrollment to begin in the third quarter of 2025, and we expect this study to span three to five years.

這項兒科研究是 FDA 《兒科研究公平法案》規定的上市後要求，我們已獲得 FDA 對最終研究計畫的同意。我們目前預計患者招募將於 2025 年第三季開始，我們預計這項研究將持續三到五年。

Lastly, in addition to our other clinical initiatives, we have commenced 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 CVC. These high-risk patients are those that have exhausted other infection prevention methods and unfortunately remain at significant risk for comorbidities and mortality.

最後，除了我們的其他臨床舉措外，我們還啟動了一項針對高風險族群的擴大就診計劃，包括但不限於兒科 TPN、患有難治性腹膜炎的腹膜透析患者以及使用 CVC 的中性粒細胞減少性腫瘤患者。這些高風險患者已經用盡了其他感染預防方法，但不幸的是，他們仍然面臨著合併症和死亡的巨大風險。

We are fielding a high number of requests for participation in this expanded access program and currently expect patients to be dosed under this program in the second quarter of this year. I would now like to turn the call over to Matt to discuss the company's fourth-quarter and full-year financial results and financial position. Matt?

我們收到了大量參與該擴大用藥計畫的請求，目前預計患者將在今年第二季接受該計畫的藥物治療。現在我想將電話轉給馬特，討論公司第四季和全年的財務表現和財務狀況。馬特？

Thanks, Joe, and good morning, everyone. I am pleased to be here today to provide an overview of our fourth-quarter and full-year 2024 financial results as well as an update on CorMedix's cash position. The company has filed its annual report on Form 10-K for the year ended December 31, 2024. I urge you to read the information contained in the report for a more complete discussion of our financial results.

謝謝，喬，大家早安。我很高興今天能在這裡概述我們的第四季度和 2024 年全年財務業績以及 CorMedix 現金狀況的最新情況。該公司已提交截至 2024 年 12 月 31 日的 10-K 表年度報告。我建議您閱讀報告中包含的信息，以便更全面地討論我們的財務結果。

With respect to our fourth quarter of 2024 financial results, our net revenue for the fourth quarter of 2024 amounted to $31.2 million. CorMedix achieved profitability in the fourth quarter as our net income was $13.5 million or $0.22 per share compared with a net loss of $14.8 million or $0.26 per share in the fourth quarter of 2023. The net income recognized in 2024 was driven by the profits associated with net sales of the DefenCath following the product's launch in 2024.

關於我們 2024 年第四季的財務業績，我們 2024 年第四季的淨收入為 3,120 萬美元。CorMedix 在第四季度實現盈利，淨收入為 1,350 萬美元，即每股 0.22 美元，而 2023 年第四季度的淨虧損為 1,480 萬美元，即每股 0.26 美元。2024 年確認的淨收入來自 2024 年 DefenCath 產品推出後其淨銷售額產生的利潤。

Operating expenses in the fourth quarter of 2024 increased 9% to $17.1 million compared with $15.7 million in the fourth quarter of 2023. The increase was driven by higher selling and marketing and G&A expenses, offset by a decrease in R&D.

2024 年第四季的營運費用較 2023 年第四季的 1,570 萬美元成長 9% 至 1,710 萬美元。成長的原因是銷售和行銷費用以及一般行政費用的增加，但被研發費用的減少所抵銷。

R&D expense decreased by 26% to $1.7 million driven by the approval of DefenCath. CorMedix is now reporting selling and marketing expense and general and administrative expense as separate line items. On an apples-to-apples basis, S&M expense increased 1% to $8.3 million in the fourth quarter of 2024 compared with $8.2 million in the fourth quarter of '23.

受 DefenCath 核准的推動，研發費用下降 26% 至 170 萬美元。CorMedix 現在將銷售和行銷費用以及一般和行政費用作為單獨的項目進行報告。以同類比較，2024 年第四季的銷售與市場支出為 830 萬美元，較 2023 年第四季的 820 萬美元成長 1%。

G&A expense increased 36% to $7.1 million in the fourth quarter of 2024 versus $5.2 million in the fourth quarter of 2023. The increase in S&M 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. The increase in G&A expense was primarily due to increases in personnel costs in preparation for support activities related to our commercial launch.

2024 年第四季的一般及行政費用 (G&A) 為 710 萬美元，較 2023 年第四季的 520 萬美元成長 36%。銷售與行銷費用的增加主要歸因於行銷力度的加強和新員工的加入，包括我們的現場銷售組織和對 DefenCath 商業發布的支援。一般及行政費用的增加主要是因為商業發布相關的支援活動做準備的人員成本增加。

With respect to our full-year 2024 financial results, total net revenue during 2024 amounted to $43.5 million This marks the first full year CorMedix is reporting net revenue since launching DefenCath in spring summer of 2024. Total operating expenses during the full-year 2024 amounted to $62.6 million compared with $49 million in 2023, an increase of 28%.

關於我們的 2024 年全年財務業績，2024 年的總淨收入為 4,350 萬美元，這是 CorMedix 自 2024 年春夏推出 DefenCath 以來首次全年報告淨收入。2024 年全年總營運費用為 6,260 萬美元，而 2023 年為 4,900 萬美元，成長 28%。

R&D expense decreased 70% to $3.9 million driven primarily by the approval of DefenCath. Selling and marketing expense increased 59% to $28.7 million compared with full-year 2023, and G&A expense increased 69% to $30 million compared with 2023. The increases in S&M and G&A were driven primarily by new personnel and cost to support the commercial launch of DefenCath.

研發費用下降 70% 至 390 萬美元，主要原因是 DefenCath 獲得批准。與 2023 年全年相比，銷售和行銷費用增加 59% 至 2,870 萬美元，一般及行政費用增加 69% 至 3,000 萬美元。銷售與行銷 (S&M) 和一般及行政費用 (G&A) 的增加主要由於新員工的加入和支持 DefenCath 商業發布的成本。

We recorded net cash used in operations during 2024 of $50.6 million compared with net cash used in operations of $38.4 million in 2023. The increase is primarily driven by an increase in trade receivables and inventories offset by a net increase in the change of accrued expenses and accounts payable and a decreased net loss.

我們記錄的 2024 年營運淨現金流為 5,060 萬美元，而 2023 年營運淨現金流量為 3,840 萬美元。成長的主要原因是貿易應收款和存貨的增加，抵消了應計費用和應付帳款變動的淨增加以及淨虧損的減少。

The company has cash and cash equivalents of $51.7 million as of December 31, 2024. Based on accounts receivable collection throughout first quarter of 2025 and to a lesser extent proceeds from ATM issuance, we anticipate completing first quarter of 2025 with at least $75 million in cash and cash equivalents.

截至 2024 年 12 月 31 日，該公司的現金和現金等價物為 5,170 萬美元。根據 2025 年第一季應收帳款的收款情況以及 ATM 發行所得的較小程度收益，我們預計 2025 年第一季的現金和現金等價物將至少達到 7,500 萬美元。

As described in our January 7 release, we are guiding to 2025 cash operating expenses of approximately $72 million to $78 million. The increase over 2024 spending levels is expected to be primarily driven by an increase in R&D spending on clinical initiatives.

正如我們 1 月 7 日發布的新聞稿中所述，我們預計 2025 年現金營運費用約為 7,200 萬至 7,800 萬美元。預計 2024 年支出水準的成長主要得益於臨床計畫研發支出的增加。

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

現在我將把電話轉回給喬，請他作最後發言。喬？

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

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

(Operator Instructions) Roanna Ruiz, Leerink Partners.

（操作員指示）Roanna Ruiz，Leerink Partners。

Hey, good morning, everybody. So I did have a question about the Syneos Health partnership and your build out of the inpatient sales team. What are your first steps for this team once they're fully launched? And do you have any color on what the ramp might look like in the inpatient setting for DefenCath over time?

嘿，大家早安。所以我確實對 Syneos Health 合作夥伴關係以及您組建的住院銷售團隊有一個疑問。一旦這個團隊全面啟動，您首先要採取什麼措施？您是否可以預見，隨著時間的推移，DefenCath 住院環境中的坡道將會是什麼樣子？

Well, look, let me -- I'll comment on the inpatient kind of ramp and then I'll let Erin and Liz comment a little bit on the team and its deployment. So obviously, we were a little bit slow at the gate on the inpatient side last year. That's not unusual for this setting of care for these types of launches. It takes quite a while to work through P&T processes.

好吧，聽著，讓我——我會對住院坡道進行評論，然後我會讓 Erin 和 Liz 對團隊及其部署進行一些評論。顯然，去年我們在住院門口有點慢。對於此類發射的關注環境來說，這並不罕見。完成 P&T 流程需要相當長的時間。

I am pleased with what we've seen in the first quarter. I know we -- as I said, we don't report anything from a separate segment standpoint on the inpatient side. But right now, for the first quarter, inpatient is looking to be about 3% of unit volume and 4% to 5% of dollars. So I feel pretty good about that trend.

我對第一季的業績感到滿意。我知道我們——正如我所說，我們沒有從住院方面的單獨部分角度報告任何內容。但目前，第一季住院病人數量約佔醫療單位數量的 3%，醫療支出約佔 4% 至 5%。所以我對這種趨勢感覺很好。

Inpatient as a total is 10% of the unit volume of the overall market opportunity. So if we can move toward there, right, as we get into 2026, I think that's certainly a target that we'd like to try to achieve.

住院病人總數佔整體市場機會單位數量的 10%。因此，如果我們能夠朝著這個目標前進，那麼，當我們進入 2026 年時，我認為這肯定是我們想要努力實現的目標。

We're in the process of just finally completing the staffing of the last two to three roles, right, to fill out the team completely. Training is near complete, and we hope to have them out in the field in the next four to five weeks. But Erin, do you want to comment anything beyond that?

我們即將完成最後兩到三個職位的人員配置，以完全填補整個團隊的空缺。訓練已接近完成，我們希望他們能夠在未來四到五週內投入實地訓練。但是艾琳，除此之外你還想發表什麼評論嗎？

Sure. I think that just what we plan for them to do right out of the gate is to focus on the large academic medical centers similar as before. They're not starting from scratch. These hospitals either have going through the P&T process now or they have already ordered DefenCath. And so we're just making sure that they've got the support they need and the ramp to order more. We're also aligning them closely with VA medical centers that are typically in the same territory or region.

當然。我認為我們為他們制定的計劃就是像以前一樣把重點放在大型學術醫療中心上。他們並不是從零開始。這些醫院要么正在進行 P&T 流程，要么已經訂購了 DefenCath。因此，我們只是確保他們獲得所需的支援並有足夠的機會訂購更多產品。我們也將它們與通常位於同一領土或地區的 VA 醫療中心緊密結合。

Got it. Thanks. And second one for me, I noticed on the call you talked about net price erosion starting in 2Q. Can you just elaborate a bit on the degree of the erosion? Could it flow into some of the subsequent quarters as well?

知道了。謝謝。對我來說第二個問題是，我注意到您在電話會議上談到了從第二季開始的淨價格侵蝕。能詳細說明一下侵蝕的程度嗎？它是否也會流入到隨後的一些季度？

Yes. Thanks, Roanna. I think it would be good to comment on the guidance we gave first and what it means. So I know it's unusual to guide for a partial part of the year. But the way we're kind of looking at it or the way I think investors should look at it is the $50 million to $60 million range is really, I guess, what you would think of as our base business, right, in terms of the customers that we're really buying by year-end and then into the early part of the first quarter.

是的。謝謝，羅安娜。我認為最好先評論一下我們給出的指導以及它的含義。所以我知道在一年中的部分時間擔任導遊是不尋常的。但我們看待這個問題的方式，或者我認為投資者應該看待這個問題的方式是，5000 萬到 6000 萬美元的範圍實際上是我們的基礎業務，就我們在年底前真正購買的客戶以及在第一季初購買的客戶而言。

Certainly, to the extent we bring in either new customers, obviously new customers, there's upside, right, from those numbers if certainly if our LDO customer starts buying in the second quarter, right, that there's upside in those numbers.

當然，只要我們引進新客戶，顯然是新客戶，那麼從這些數字來看就有上行空間，如果我們的 LDO 客戶在第二季開始購買，那麼這些數字就有上行空間。

Now when we talk about price erosion, I'm not going to -- I don't know if I can give you an exact percentage, but the way in which we're thinking about it is our agreements with customers and the way that we're currently priced, there are, let's say, discounts and rebates off of government ASP. And government ASP has remained kind of stable, right? It starts out at WAC during TDAPA and then it adjusts for the first quarter. I think it was down only 1% from what it was the prior quarter.

現在，當我們談論價格下降時，我不會——我不知道是否可以給你一個確切的百分比，但我們考慮這個問題的方式是我們與客戶的協議以及我們目前的定價方式，比如說，政府平均售價的折扣和回扣。政府的平均售價一直保持穩定，對嗎？它在 TDAPA 期間從 WAC 開始，然後針對第一季進行調整。我認為它僅比上一季下降了 1%。

Next quarter is still -- second quarter going to be fairly stable. The third quarter, it should come down a little bit. But we're going to have to -- or we're expecting to take a shelf stock adjustment at the end of the second quarter, right, as we move into third.

下個季度——第二季度仍然會相當穩定。第三季度，這一數字應該會略有下降。但我們必須——或者說，我們預計在第二季末，也就是進入第三季時，進行庫存調整。

And what we don't really have a handle on right now is exactly how much inventory will be in the channel by the end of the second quarter. So that's something that we're still working through and that kind of factors into the range that we gave for revenue from existing base, what we'll call the existing base business over the first part of the year.

而我們現在真正無法掌握的是到第二季末通路中到底有多少庫存。所以這是我們仍在努力解決的問題，這些因素都會影響我們給出的現有基礎收入範圍，我們稱之為今年上半年的現有基礎業務。

Jason Butler, Citizens JMP.

傑森‧巴特勒 (Jason Butler)，公民 JMP。

Hi. Thanks for taking the question and congrats on the progress in the quarter. Joe, can you maybe just give us some more color about the process that the contracted LDO is going through and your interactions that kind of just reinforce your confidence that they will begin ordering in the next couple of months, next few months?

你好。感謝您提出這個問題，並對本季的進展表示祝賀。喬，您能否向我們詳細介紹 LDO 合約簽訂的流程以及您的互動情況，這些互動是否增強了您對他們將在未來幾個月內開始訂購的信心？

Thanks, Jason. Look, I think what I can say at this point of time is we're being as supportive as we can possibly be. We've had a lot of information requests come from them, right, specifically around support services we could provide for training, for reimbursement.

謝謝，傑森。聽著，我想此時此刻我能說的是，我們正在盡最大努力提供支持。我們收到了很多來自他們的資訊請求，特別是關於我們可以提供的培訓、報銷支援服務。

And we're making our staff available to them right kind of across the board. So as I said, we're hopeful that we'll stick with the original kind of planned or communicated timeline of implementation by mid-year. But that's really all I have to go on at this point in time.

我們正在為他們提供全方位的工作人員服務。正如我所說，我們希望能夠堅持最初計劃或傳達的年中實施時間表。但這確實是我目前所能做的一切。

Okay. Helpful. And then just from in terms of the magnitude of use within the LDO, has that number remained consistent throughout your dialogue with them?

好的。很有幫助。那麼僅從 LDO 內的使用量來看，在與他們的對話過程中，這個數字是否保持一致？

Yeah. Look, they haven't given us any indication right now that that number or they're going to deviate from that number, but we do know they're looking at implementation. I think there's a possibility that number could be higher. There's a possibility that number could be lower, right? I think what we're trying to do right now, as I said, is make all the resources of CorMedix available to them and hopefully accelerate the rollout, both in terms of speed and scale.

是的。你看，他們現在還沒有給我們任何跡象表明這個數字或他們會偏離這個數字，但我們確實知道他們正在考慮實施。我認為這個數字有可能更高。這個數字有可能更低，對嗎？我認為，正如我所說，我們現在正在嘗試做的是向他們提供 CorMedix 的所有資源，並希望在速度和規模方面加快推廣速度。

Great. And then just a second one for me. In terms of potential new customers, obviously, there's the other LDO. Could you give us an update there? But beyond that, are there other smaller providers that potentially could come online in the second half of the year? Thanks.

偉大的。然後對我來說就第二個了。就潛在的新客戶而言，顯然還有另一個 LDO。您能提供我們最新進展嗎？但除此之外，是否有其他規模較小的供應商可能在今年下半年上線？謝謝。

Yeah, thanks. Look, with respect to the other LDO, obviously, we remain in communication with them. We've provided them additional information. I think candidly, we haven't moved the needle there as much as we would have liked to over the past couple of months. We are still working there, call it, top down, right, for the senior level of management.

是的，謝謝。您看，關於其他 LDO，顯然我們仍與他們保持溝通。我們向他們提供了更多資訊。坦白說，我認為在過去的幾個月裡，我們並沒有取得我們所希望的那麼大的進展。我們仍然在那裡工作，稱之為自上而下，對的，為高層管理人員服務。

We've also started to work there bottom up, right? A lot of these large Dallas Operators, they have joint venture owned entities where the JV partner has some decision making authority. So we've started to work through some of those joint venture organizations that have expressed interest in DefenCath, and we're hopeful to kind of make inroads there over the next two to three months.

我們也已經開始自下而上地開展工作了，對嗎？許多大型達拉斯業者都擁有合資企業，合資夥伴擁有一定的決策權。因此，我們已經開始與一些對 DefenCath 感興趣的合資組織合作，我們希望在未來兩到三個月內取得進展。

On the small side, yes, right, there are a lot of I guess, first, I'd say we are shipping to a number of small customers where we don't talk about them specifically. Some may have 10 dialysis centers, some might have 20, but -- in addition to some health systems that have, right, 10 to 25 hospitals. But yes, that's absolutely part of our focus over the next part of 2025 to build inroads with those smaller customers and to increase ordering size and frequency.

從小處來說，是的，對，我想有很多，首先，我想說我們正在向一些小客戶發貨，我們不會具體談論他們。有些可能有 10 個透析中心，有些可能有 20 個，但有些醫療系統甚至有 10 到 25 家醫院。但是的，這絕對是我們 2025 年下半年的工作重點之一，即與那些較小的客戶建立聯繫，並增加訂購規模和頻率。

Gregory Renza, RBC Capital Markets.

加拿大皇家銀行資本市場 (RBC Capital Markets) 的 Gregory Renza。

Hi, guys. It's Anish on for Greg. Congrats on all the progress and thanks for taking our questions. Just a couple from us. First, just on TDAPA, how should we be thinking about patient applicability and what are your thoughts and trends in coverage such as Medicare Advantage over the next two to three years? And second, what are the key levers you look to pull to maximize uptake of DefenCath to ensure the best possible post TDAPA add on adjustment? Thanks so much.

嗨，大家好。阿尼什 (Anish) 取代格雷格 (Greg)。恭喜您取得的所有進展，並感謝您回答我們的問題。距離我們只有幾對。首先，僅就 TDAPA 而言，我們應該如何考慮患者的適用性，以及您對未來兩到三年內醫療保險優勢計劃 (Medicare Advantage) 等保險範圍的想法和趨勢是什麼？其次，您希望採取哪些關鍵措施來最大限度地提高 DefenCath 的吸收率，以確保最佳的 TDAPA 後附加調整？非常感謝。

Thanks, Anish. Look, I think with respect to TDAPA, I'm not sure what you meant by applicability, but in terms of what we're seeing -- I'll start now with what we're seeing from Medicare Advantage now, right? So when we look at our payer claims, we launched the product in mid-2024 in the outpatient setting and initially 100% of claims were fee for service, right?

謝謝，阿尼什。聽著，我認為就 TDAPA 而言，我不確定您所說的適用性是什麼意思，但就我們所看到的情況而言——我現在就從我們現在從 Medicare Advantage 看到的情況開始，對嗎？因此，當我們查看付款人索賠時，我們會發現我們於 2024 年中期在門診環境中推出了該產品，並且最初 100％ 的索賠都是按服務收費的，對嗎？

Because it's the Medicare Advantage, there's a little bit of a lag in picking up TDAPA. And as we move toward the back part of last year, we started to see the trend going toward Medicare Advantage. I think we closed out last year with about 25% or 30% of our claims being Medicare Advantage.

由於這是醫療保險優勢計劃，因此在領取 TDAPA 方面會有些滯後。隨著去年下半年的臨近，我們開始看到醫療保險優勢計劃 (Medicare Advantage) 的趨勢正在轉變。我認為，去年我們約有 25% 或 30% 的索賠來自醫療保險優勢計劃。

Through this first part of the first quarter, 40% of our claims are Medicare Advantage and other payers and 60% are fee for service. That's certainly the trend we want to see. When you look at the broader ESRD market 80%, 85% of it is Medicare. And within Medicare, half of it is fee for service and half is Medicare Advantage.

在第一季的前半部分，我們 40% 的索賠來自醫療保險優勢計劃和其他付款人，60% 是服務費。這當然是我們希望看到的趨勢。當你觀察更廣泛的 ESRD 市場時，你會發現其中 80%、85% 是醫療保險。在醫療保險中，一半是服務費，一半是醫療保險優勢費。

We do see the Medicare Advantage market share of Medicare growing over time. We do think it ultimately will become 70% of ESRD patients. And we do see that as a good opportunity for CorMedix. So what we're doing to better prepare ourselves, call it, for the out years of TDAPA and beyond is the real-world evidence study that we're running in collaboration with US Renal Care, right?

我們確實看到醫療保險優勢計劃的市場份額隨著時間的推移而增長。我們確實認為最終 ESRD 患者的比例將達到 70%。我們確實認為這對 CorMedix 來說是一個很好的機會。那麼，為了更好地為 TDAPA 的未來幾年及以後做好準備，我們正在與美國腎臟保健中心合作進行真實世界證據研究，對嗎？

A lot of that data and specifically around the pharmacoeconomic benefits of DefenCath is what we'd like to utilize as part of a direct contract negotiation with EMA plans, right, for separate and more sustainable reimbursement. Did I address the second question as well, Anish?

我們希望利用大量數據，特別是有關 DefenCath 的藥物經濟學效益的數據，作為與 EMA 計劃直接簽訂合約談判的一部分，以實現單獨且更可持續的報銷。我是否也回答了第二個問題，阿尼什？

Yeah, that's very helpful. Thank you.

是的，這非常有幫助。謝謝。

Les Sulewski, Truist Securities.

Les Sulewski，Truist Securities。

Hey, this is Jeevan on for Les. Thanks for taking our questions. We recently saw the news on FDA's acknowledgments of bloodline shortages that might impact hemodialysis procedures. Can you provide any commentary if this has any impact on utilization or uptake of DefenCath? Thank you.

嘿，我是 Jeevan，為 Les 服務。感謝您回答我們的問題。我們最近看到了有關 FDA 承認血液供應短缺可能會影響血液透析程序的新聞。您能否評論一下這是否會對 DefenCath 的利用或吸收產生影響？謝謝。

Yeah. Hi, thanks, Jeevan. No, it's not likely to have any impact, but I'll let Liz explain why.

是的。嗨，謝謝，Jeevan。不，這不太可能產生任何影響，但我會讓 Liz 解釋原因。

Yeah. So thanks for the question. The good news is that there are two equivalent alternative manufacturers for this. So hemodialysis isn't going to stop. I think that the dialysis providers feel pretty good about that. But I don't anticipate any impact to DefenCath utilization with this. It's simply a manufacturing challenge that can be addressed with alternatives.

是的。感謝您的提問。好消息是，有兩家同等的替代製造商。因此血液透析不會停止。我認為透析提供者對此感覺很好。但我預計這不會對 DefenCath 的使用產生任何影響。這只是一個可以透過替代方案解決的製造挑戰。

Okay, great. Then just a quick second one for me. Can you provide any updates on the status of DefenCath manufacturing capacity? Have there been any readjustments needed or challenges to filling the open purchase orders to Q1? Thank you.

好的，太好了。然後對我來說只需快速進行第二次。您能提供任何關於 DefenCath 製造能力現況的最新消息嗎？在完成第一季的未結帳採購訂單時，是否需要進行任何調整或面臨任何挑戰？謝謝。

I'm sorry, Jeevan. Was that question around inventory availability?

對不起，傑文。這個問題是關於庫存可用性的嗎？

Yeah, yeah. Just your capacity there and any challenges in filling [$24 million] in open purchase orders?

是啊是啊。您在那裡的產能以及在履行 [2400 萬美元] 未結採購訂單方面遇到什麼挑戰？

No, we have more than a year's worth of finished dosage on hand at our current run rate. We're well-situated.

不，按照我們目前的運行速度，我們手頭上有足夠一年使用的成品劑量。我們的位置很好。

Serge Belanger, Needham & Company.

塞爾日·貝朗格（Serge Belanger），Needham & Company。

Hi. Good morning. This is John on for Serge today. Thanks for taking our questions. First, if you can just quickly give us the current business mix between the various MDOs that you have on board. Obviously, US Renal Care has been your anchor thus far. And secondly, in terms of the expectations for the TPN program, are these patients going to be similar to those that were enrolled in the LOCK-IT trial in terms of CRBSI susceptibility?

你好。早安.今天由約翰代替塞爾吉上場。感謝您回答我們的問題。首先，您能否快速向我們介紹一下目前您旗下各個 MDO 之間的業務組合。顯然，到目前為止，美國腎臟護理中心一直是您的支柱。其次，就 TPN 計劃的預期而言，這些患者在 CRBSI 易感性方面是否與參與 LOCK-IT 試驗的患者相似？

All right. Thanks, John. In a minute, I'll let Liz comment on the study design for TPN. From a business mix standpoint, I think we have exact percentages in the 10-K for the way we closed out last year. Obviously, US Renal Care still remains more than 80% of orders through that period. It is coming down. Beyond that, I don't think we're going to be providing specific customer specific guidance, but we'll re-evaluate as we go forward. Do you want to comment on the study design on TPN?

好的。謝謝，約翰。稍後，我將讓 Liz 對 TPN 的研究設計進行評論。從業務組合的角度來看，我認為我們在 10-K 中已經包含了與去年收盤時完全相同的百分比。顯然，US Renal Care 在此期間仍然保持著 80% 以上的訂單。它正在下降。除此之外，我認為我們不會提供針對特定客戶的具體指導，但我們會在前進的過程中重新評估。您想評論一下 TPN 的研究設計嗎？

Sure. So our [NutriGuard] study, which is our Phase 3 randomized double-blind two-arm study, which is looking at the efficacy and safety of DefenCath for adult patients receiving TPN is really focused on those that have had a CLABSI in the last 12 months.

當然。因此，我們的 [NutriGuard] 研究，即我們的 3 期隨機雙盲雙臂研究，旨在研究 DefenCath 對接受 TPN 的成年患者的療效和安全性，主要關注的是過去 12 個月內發生過 CLABSI 的患者。

We know that patients that have had a CLABSI are at higher risk to have another one. They have an average infection rate of 20% to 25%. So similar to dialysis patients in the sense that they are very vulnerable to infection, and they may be immunocompromised for a multitude of reasons, right? That's why they're probably on TPN.

我們知道，曾經發生過 CLABSI 的患者再次發生 CLABSI 的風險更高。他們的平均感染率為20%至25%。那麼，他們與透析患者非常相似，因為他們非常容易受到感染，並且可能由於多種原因而導致免疫功能低下，對嗎？這可能是他們接受 TPN 治療的原因。

But unlike dialysis, these are folks that access their catheter on a daily basis, not three times a week like you would see in hemodialysis. Does that answer your question?

但與透析不同的是，這些人每天都需要插入導管，而不是像血液透析那樣每週插入三次。這回答了你的問題嗎？

Yeah, that's great. Thank you very much.

是的，太棒了。非常感謝。

Thank you. And this concludes the audio question-and-answer session. I'd like to turn the conference back over to Dan Ferry from LifeSci Advisors for written questions.

謝謝。音頻問答環節到此結束。我想將會議交還給 LifeSci Advisors 的 Dan Ferry 來回答書面問題。

Thank you, operator. Joe, we do have some written questions from the audience. The first will be, did the change in CMMI, which is the Center for Medicare and Medicaid Innovation, did that policy impact patient uptake in the first quarter?

謝謝您，接線生。喬，我們確實收到了一些觀眾的書面問題。首先是，CMMI（醫療保險和醫療補助創新中心）的變化是否影響了第一季的病患接受度？

Okay. Thanks, Dan. I think what you're referring to is the policy change that took place back in November that removed or the patients that participate in a kidney care entity, the benchmarks, they excluded TDAPA from the benchmarks. So they were now allowed to accept TDAPA payments and not be penalized.

好的。謝謝，丹。我認為您指的是去年 11 月發生的政策變化，該政策取消了或取消了參與腎臟護理實體的患者的基準，他們將 TDAPA 排除在基準之外。因此他們現在被允許接受 TDAPA 付款並且不會受到懲罰。

I think at the time, we guided, we did expect a patient lift of somewhere around 15% to 20%. We did see that throughout the first quarter certainly with US Renal Care that we saw a lift in patient numbers as a result of that. And I think overall, I think it's important for innovative products in general, right? It was somewhat of a headwind that thankfully CMS eliminated.

我認為當時我們確實預期患者人數會增加 15% 到 20% 左右。我們確實看到，在整個第一季度，美國腎臟護理中心的患者數量有所增加。我認為總體而言，這對於創新產品來說很重要，對嗎？這有點像是逆風，幸好 CMS 消除了它。

Okay, great. And I have another one here. Proposed changes from the new administration have certainly caused volatility in the sector. Have you seen anything in these announcements that you see as a risk or possibly an opportunity?

好的，太好了。我這裡還有另外一個。新政府提出的改革措施無疑為該行業帶來了波動。在這些公告中，您是否看到了任何您認為是風險或機會的東西？

Yeah. Look, I know there's a lot of trepidation from investors right now, certainly in the biotech segment, right, because the new administration and potential tariffs on pharmaceuticals. I think the way we're looking at it specific to DefenCath is definitely more of an opportunity. And I think I would divide it probably in a couple of buckets.

是的。聽著，我知道現在投資者有很多擔憂，尤其是在生技領域，因為新政府和潛在的藥品關稅。我認為，我們針對 DefenCath 的觀察方式無疑更具機會。我認為我可能會把它分成幾個類別。

I think if you're looking at the situation through the lens of, let's say, DOGE, right, and kind of taking cost out of government spend, I think DefenCath is something that fits very well with that agenda, right? So the government spends over $3 billion a year between inpatient and outpatient derived CRBSIs in the hemodialysis space. If we can replicate our clinical result in a real-world setting, we have the opportunity to offset a large amount of that spend.

我認為，如果你從 DOGE 的角度來看待這種情況，並且從政府支出中扣除成本，我認為 DefenCath 非常符合這一議程，對嗎？因此，政府每年在血液透析領域住院和門診 CRBSI 治療上花費超過 30 億美元。如果我們能夠在現實環境中複製我們的臨床結果，我們就有機會抵消大量的支出。

Second, I think if you're looking at it through the lens of, let's say, make America healthy again, right, type thing, I think we also fit pretty well, right, with that type of mindset where, if we are able to have the -- again, replicate our clinical results in a real-world setting and have that type of impact on infections, a byproduct of that is you're reducing hospitalizations from those infections.

其次，我認為，如果你從讓美國再次恢復健康的角度來看待這個問題，對吧，這類事情，我認為我們也非常符合這種思維方式，如果我們能夠——再次，在現實世界中復制我們的臨床結果並對感染產生這種影響，那麼這樣做的副產品就是減少了因這些感染而住院的人數。

You'd ultimately be reducing antibiotic use that would result from those infections. I think both of which fit pretty well within that initiative. I think more broadly for this administration, though, I think we do get just because it's a change of administration, not because of who the administration is, I think there is the ability to look at either past decisions through a new lens or new legislative initiatives.

您最終將減少因這些感染而導致的抗生素的使用。我認為這兩者都非常適合這項倡議。不過，我認為從更廣泛的角度來看，對於本屆政府而言，我認為我們確實能夠透過新的視角或新的立法舉措來審視過去的決定，因為這只是政府的更迭，而不是因為政府是誰。

And certainly, there's a lot of, I think, momentum right now on a bipartisan basis for, hopefully, TDAPA reform. I think TDAPA was a really good start. I think it's -- we've done okay but I think everybody recognizes from a long-term standpoint that it certainly could be better in terms of incentivizing innovation, reimbursing providers for utilizing that innovation.

當然，我認為目前兩黨對 TDAPA 改革的勢頭非常強勁，希望如此。我認為 TDAPA 是一個非常好的開始。我認為——我們做得還不錯，但我認為從長遠來看每個人都意識到，在激勵創新、補償供應商利用創新方面，我們肯定可以做得更好。

And we do know that there's a bill that's hopefully making its way through Congress and hopefully will be proposed before the end of this year. And if not, hopefully, CMS through rulemaking can make some more positive adjustments. But I think for us and our situation specifically, I think we see a lot of opportunity.

我們確實知道，有一項法案預計在國會獲得通過，並預計在今年年底前提出。如果沒有，希望 CMS 能夠透過制定規則做出一些更積極的調整。但我認為，就我們和我們的具體情況而言，我們看到了很多機會。

Great. Thank you for that, Joe. I have another one here that's a bit more on the commercial side of things. What resources does CorMedix have available to help providers with processing reimbursement?

偉大的。謝謝你，喬。我這裡還有另外一個，它比較偏向商業方面。CorMedix 有哪些資源可協助供應商處理報銷？

It's a good question. Yeah, so we've set up a third-party hub specifically to help the providers themselves navigate claims. And Erin, do you want to -- it's through a third-party. Erin, do you want to comment on how that's set up?

這是個好問題。是的，因此我們專門設立了一個第三方中心來幫助提供者自己處理索賠。艾琳，你想透過第三方嗎？艾琳，你想評論一下它的設定方式嗎？

Sure. So third-party prospectus and they work directly with both us and our customers across, inpatient and outpatient settings. There's a couple of main focus areas. One of those is benefits verification for patients, and then they have very specific billing and coding expertise to make sure that claims are submitted correctly for TDAPA, for example, on the outpatient side and NTAP on the inpatient side, as well as the J-codes. And then they also can navigate any payer policies or complex state Medicaid challenges that we may run into.

當然。因此，第三方招股說明書直接與我們以及我們的客戶合作，涉及住院和門診環境。有幾個主要關注領域。其中之一是對患者的福利驗證，然後他們擁有非常具體的計費和編碼專業知識，以確保正確提交 TDAPA 的索賠，例如在門診方面和住院方面以及 J 代碼的 NTAP 的索賠。然後他們還可以解決我們可能遇到的任何付款人政策或複雜的州醫療補助挑戰。

Okay, great. Thanks, Erin. Looks like we have one final one here. I think you touched on this earlier, Joe. But if signing an agreement or a currently contracted LDO requires greater capacity, what is your ramp time? And how is CorMedix situated from a raw material standpoint?

好的，太好了。謝謝，艾琳。看起來我們這裡還有最後一個。喬，我想你之前已經提到過這一點。但是，如果簽署協議或目前簽約的 LDO 需要更大的容量，那麼您的提升時間是多少？從原料角度來看，CorMedix 處於什麼位置？

Okay. Thanks. So I guess that goes back to inventory. So I think we divide into a couple of buckets. I said before, from a finished dosage standpoint, I think we're in pretty good shape based on the current run rate any anticipated ramp that we kind of built into our LE, right, for the what we expected the LDO customer to do now. If they wanted to ramp significantly beyond that, our ability to pivot is pretty good, right?

好的。謝謝。所以我想這又回到庫存問題了。所以我認為我們可以分成幾個類別。我之前說過，從最終劑量的角度來看，我認為根據目前的運行率，我們的狀況非常好，我們在 LE 中構建的任何預期坡道，對於我們期望 LDO 客戶現在做的事情來說，都是如此。如果他們想大幅超越這一點，我們的調整能力還是相當不錯的，對嗎？

I don't think our ramp time is more than a handful of months. We have more than enough raw material on hand between, I'd say, heparin and taurolidine API to cover that ramp over a year. Turnaround time on heparin API is not significant. Turnaround time on taurolidine API is a bit longer, but we have several lots on order, that would be delivered in the back part of the year.

我認為我們的提升時間不會超過幾個月。我想說，我們手邊有足夠的肝素和牛磺羅定 API 原料，足以滿足一年內的需求。肝素 API 的周轉時間並不長。牛磺羅定 API 的周轉時間稍長，但我們已經訂購了幾批，將在年底交付。

So really, we've got two finished dosage contract manufacturers. One of them is definitely underutilized. So we have finished dosage capacity we can pivot to. And I think it's a matter of handful of months to be able to ramp.

所以實際上，我們有兩家成品劑量合約製造商。其中之一肯定沒有得到充分利用。因此，我們已經完成了可以轉向的劑量容量。我認為只需幾個月的時間就能實現成長。

That's great. Thank you so much, Joe. Operator, this concludes the written question portion of the call. You may now close.

那太棒了。非常感謝，喬。接線員，通話中的書面問題部分到此結束。您現在可以關閉了。

Thank you. Ladies and gentlemen, this concludes today's conference call. We thank you all for attending today's presentation. You may now disconnect your lines and have a wonderful day.

謝謝。女士們、先生們，今天的電話會議到此結束。感謝大家參加今天的演講。現在您可以斷開線路並享受美好的一天。