CorMedix Inc (CRMD) 2023 Q4 法說會逐字稿

Good morning, ladies and gentlemen, and welcome to the CorMedix Inc., fourth-quarter and full-year 2023 earnings call. (Operator Instructions) This call is being recorded on March 12, 2024.

早安，女士們、先生們，歡迎參加 CorMedix Inc. 2023 年第四季和全年財報電話會議。（操作員說明）此通話錄音時間為 2024 年 3 月 12 日。

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

我現在想將會議轉交給 LifeSci Advisors 的 Dan Ferry。請繼續。

Good morning and welcome to the CorMedix full-year 2023 earnings conference call. Leading the call today is Joe Todisco, Chief Executive Officer of CorMedix. He is joined by Dr. Matt David, Executive Vice President and CFO; Beth Zelnick Kaufman, EVP and Chief Legal Officer; Liz Hurlburt, EVP of Chief Clinical Strategy and Operations Officer; and Erin Mistry, EVP and Chief Commercial Officer.

早安，歡迎參加 CorMedix 2023 年全年財報電話會議。今天主持電話會議的是 CorMedix 執行長 Joe Todisco。執行副總裁兼財務長 Matt David 博士也加入了他的行列； Beth Zelnick Kaufman，執行副總裁兼首席法務長； Liz Hurlburt，執行副總裁兼首席臨床策略和營運長；和艾琳·米斯特里（Erin Mistry），執行副總裁兼首席商務官。

Before we begin, I would like to remind everyone that during the call, management may make what are known as forward-looking statements within the meaning set forth in the Private Securities Litigation Reform Act of 1995.

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》所規定含義內的所謂前瞻性陳述。

These statements are subject to certain risks and uncertainties and include but are not limited to any of the following: any statements other than statements of historical fact regarding management’s expectations, beliefs, goals, and plans about the company’s prospects, including its commercial launch prospects for DefenCath, its clinical development programs for expanded uses of DefenCath, manufacturing activities and marketing approvals for other product candidates, future financial position, future revenues and projected costs, and reimbursement and potential market acceptance of DefenCath or other product candidates.

這些陳述存在一定的風險和不確定性，包括但不限於以下任何內容：除了有關管理層對公司前景的期望、信念、目標和計劃的歷史事實陳述之外的任何陳述，包括DefenCath 的商業推出前景、擴大DefenCath 用途的臨床開發計劃、其他候選產品的製造活動和行銷批准、未來財務狀況、未來收入和預計成本，以及DefenCath 或其他候選產品的報銷和潛在市場接受度。

Actual results may differ materially from these projections or estimates due to a variety of important factors, including but not limited to uncertainties related to clinical development, regulatory approvals, and commercialization. These risks are described in greater detail in CorMedix’s filings with the SEC, including the latest quarterly report on Form 10-Q and annual report on Form 10-K, copies of which are available free of charge at the SEC’s website at www.sec.gov or upon request from CorMedix.

由於各種重要因素，包括但不限於與臨床開發、監管批准和商業化相關的不確定性，實際結果可能與這些預測或估計有重大差異。這些風險在 CorMedix 向 SEC 提交的文件中進行了更詳細的描述，包括最新的 10-Q 表季度報告和 10-K 表年度報告，這些報告的副本可在 SEC 處免費獲取。網站www.sec. gov 或根據CorMedix 的要求。

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

CorMedix 可能實際上無法實現這些前瞻性聲明中所述的目標或計劃。投資者不應過度依賴這些陳述。請注意，除法律要求外，CorMedix 無意更新這些前瞻性聲明。

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

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

Thanks Dan. Good morning everyone and thank you for joining us on this call. Since we last presented earnings in November, the company has achieved a number of key milestones, most notably the final NDA approval of DefenCath by the US FDA, as well as confirmation from CMS that DefenCath will be eligible to receive a transition drug add-on payment, or TDAPA, for outpatient reimbursement as CMS has classified DefenCath for renal dialysis service under the end-stage renal disease prospective payment system.

謝謝丹。大家早安，感謝您參加我們的這次電話會議。自我們上次在 11 月公佈收益以來，該公司已實現了許多關鍵里程碑，最引人注目的是美國 FDA 對 DefenCath 的最終 NDA 批准，以及 CMS 確認 DefenCath 將有資格獲得過渡藥物附加產品CMS 已將DefenCath 腎臟透析服務納入末期腎病變前瞻性支付系統，因此門診報銷採用TDAPA 支付方式。

As we previously announced, we submitted our HEPS J-code application to CMS in December and our TDAPA application in January following receipt of that reimbursement guidance from CMS. Those applications remain under review at CMS and CMS has confirmed in writing that they are actively reviewing our J-code and TDAPA applications and are working toward a July 1, 2024, effective implementation for a DefenCath TDAPA payment.

正如我們之前宣布的，在收到 CMS 的報銷指南後，我們於 12 月向 CMS 提交了 HEPS J 代碼申請，並於 1 月向 CMS 提交了 TDAPA 申請。這些申請仍在 CMS 審核中，CMS 已書面確認，他們正在積極審查我們的 J 代碼和 TDAPA 申請，並致力於在 2024 年 7 月 1 日有效實施 DefenCath TDAPA 付款。

That said, CMS reserves the right to request additional information for any application, which may impact the review timing and/or probability of a J-code or TDAPA. Both a J-code and an approved and effective TDAPA application are gating items for the outpatient commercial launch of DefenCath, which is currently slated for July 1.

也就是說，CMS 保留要求任何申請提供額外資訊的權利，這可能會影響 J 代碼或 TDAPA 的審核時間和/或機率。J 代碼和經批准且有效的 TDAPA 申請都是 DefenCath 門診商業推出的准入項目，目前定於 7 月 1 日推出。

The company remains on schedule to commence our commercial launch for the in-patient setting on April 15. We have staffed and trained our field sales and medical affairs organizations and held a successful internal team launch meeting during the last week of February.

該公司仍按計劃於 4 月 15 日開始針對住院環境的商業發布。我們為現場銷售和醫療事務組織配備了人員並進行了培訓，並在二月的最後一周成功舉辦了內部團隊啟動會議。

The team we have built is deeply experienced and specialized with backgrounds in both infectious disease and nephrology spanning both the in-patient and out-patient settings of care. We are also ramping up inventory production in accordance with our internal plan, which is heavily weighted toward the back part of the year.

我們建立的團隊經驗豐富，專業背景涵蓋住院和門診護理的傳染病和腎臟病學。我們還根據我們的內部計劃增加庫存生產，該計劃主要集中在今年下半年。

As part of our supply chain strategy, the company is on track to submit a supplement to our NDA in April qualifying Siegfried’s site in Hameln, Germany as an alternative manufacturing site for DefenCath. Assuming a favorable FDA review of the supplement, additional production from that site would come online by the end of 2024.

作為我們供應鏈策略的一部分，該公司預計在 4 月提交 NDA 補充文件，將 Siegfried 位於德國哈默爾恩的工廠定為 DefenCath 的替代製造工廠。假設 FDA 對該補充劑進行了有利的審查，該網站的額外生產將在 2024 年底上線。

As we think about the in-patient launch trajectory in April, we do expect the ramp for our in-patient utilization to be fairly modest over the first two launch quarters as in-patient health systems and hospitals are working through their respective P&T formulary review processes. On average, the P&T process for a particular system or hospital can range from three to nine months.

當我們考慮 4 月住院患者的推出軌跡時，我們確實預計在前兩個推出季度，住院患者的使用率將相當溫和，因為住院醫療系統和醫院正在進行各自的 P&T 處方審查流程。平均而言，特定係統或醫院的 P&T 流程可能為三到九個月。

That said, we have received significant interest over the last few months and are actively working through the P&T process with several large- and mid-sized health systems. We expect this activity to intensify in the coming months as our field-based key account managers have just begun calling on hospitals and health systems to effectuate pre-launch contracting discussions.

也就是說，在過去幾個月裡，我們引起了極大的興趣，並正在積極與幾個大中型衛生系統合作進行 P&T 流程。我們預計這項活動將在未來幾個月內加強，因為我們的現場大客戶經理剛開始呼籲醫院和衛生系統進行啟動前的合約討論。

On the out-patient side, we continue to have productive discussions with large- and mid-sized dialysis operators and we look forward to providing additional updates over the coming months as these discussions advance. Based upon our forecast -- current base case forecast for 2024, we continue to believe that the company can achieve breakeven profitability on a run rate basis by the end of December 2024, assuming we are able to achieve our internal base case assumptions for DefenCath demand, uptake, net pricing and reimbursement.

在門診方面，我們繼續與大中型透析業者進行富有成效的討論，我們期待在未來幾個月隨著這些討論的進展提供更多更新。根據我們的預測——目前對 2024 年的基本情況預測，我們仍然相信，假設我們能夠實現對 DefenCath 需求的內部基本情況假設，到 2024 年 12 月底，公司可以在運行率基礎上實現盈虧平衡盈利能力、吸收、淨定價和報銷。

We believe we have sufficient cash resources on hand to achieve this objective, however should the launch and uptake of DefenCath be slower than our internal projections, requiring more capital, we believe we have several financing alternatives available to the company, including non-dilutive sources of financing.

我們相信我們手頭上有足夠的現金資源來實現這一目標，但是，如果DefenCath 的推出和採用速度慢於我們的內部預測，需要更多資金，我們相信我們有多種可供公司使用的融資替代方案，包括非稀釋性來源的融資。

CorMedix has grown in size with the addition of new hires in field sales and medical affairs, as well as other additions across the organization. I am thankful for all of those involved in the latest expansion, our new team members, and all the work that has gone into preparing the company for our anticipated commercial launch. I am proud of what we’ve accomplished over these recent months and excited to bring DefenCath to patients.

隨著現場銷售和醫療事務領域新員工的增加以及整個組織的其他人員的增加，CorMedix 的規模不斷擴大。我感謝所有參與最新擴展的人員、我們的新團隊成員，以及為公司準備我們預期的商業發布所做的所有工作。我對我們最近幾個月所取得的成就感到自豪，並很高興將 DefenCath 帶給患者。

I would now like to turn over the call to Matt to discuss the company’s fourth quarter and year-end financial results and financial position. Matt?

我現在想把電話轉給馬特，討論公司第四季和年底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 2023 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, 2023. 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。我很高興今天來到這裡，概述我們的第四季度和 2023 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 2023 年 12 月 31 日止年度的 10-K 表格年度報告。我敦促您閱讀報告中包含的信息，以便對我們的財務表現進行更完整的討論。

With respect to our fourth quarter of 2023 financial results, our net loss was approximately $14.8 million or $0.26 per share compared with a loss of $8.2 million of $0.20 per share in the fourth quarter of 2022. The higher net loss recognized in 2023 compared with 2022 was primarily driven by increases in costs related to market research studies and pre-launch activities for DefenCath and increases in personnel expenses due to new hires in 2023 compared to the same period in 2022.

就我們 2023 年第四季的財務業績而言，我們的淨虧損約為 1,480 萬美元，即每股 0.26 美元，而 2022 年第四季的淨虧損為 820 萬美元，即每股 0.20 美元。與 2022 年相比，2023 年確認的淨虧損較高，主要是由於與市場研究和 DefenCath 啟動前活動相關的成本增加，以及 2023 年新員工與 2022 年同期相比導致的人員費用增加。

Operating expenses in the fourth quarter of 2023 (inaudible) approximately 86% to $15.7 million compared with $8.4 million in the fourth quarter of 2022. R&D expense decreased by approximately 19% to $2.3 million, driven primarily by decreases in manufacturing costs related to DefenCath.

2023 年第四季的營運費用（聽不清楚）約為 86%，達到 1,570 萬美元，而 2022 年第四季的營運費用為 840 萬美元。研發費用下降約 19% 至 230 萬美元，主要是因為與 DefenCath 相關的製造成本下降。

SG&A expense increased approximately 140% to $13.4 million in the fourth quarter of 2023 compared with $5.6 million in the fourth quarter of 2022. This increase was primarily attributable to an increase in costs related to launch activities and higher personnel costs due to the additional hires in Q4.

2023 年第四季的 SG&A 費用成長約 140%，達到 1,340 萬美元，而 2022 年第四季為 560 萬美元。這一增長主要是由於與發射活動相關的成本增加以及第四季度額外招聘導致的人員成本增加。

With respect to our full-year 2023 financial results, total operating expenses during the full-year 2023 amounted to $49 million compared with $30.7 million in 2022, an increase of 60%. R&D expense increased 23% to $13.2 million, driven primarily by an increase in personnel expenses, an increase in costs related to medical affairs activities, and an increase in costs related to the technical and quality operations for the manufacturing of DefenCath prior to its marketing approval.

就我們2023年全年的財務表現而言，2023年全年的總營運費用為4,900萬美元，與2022年的3,070萬美元相比，成長了60%。研發費用增加 23% 至 1,320 萬美元，主要是由於人事費用增加、與醫療事務活動相關的成本增加，以及與上市批准之前 DefenCath 製造的技術和品質運營相關的成本增加。

SG&A expense increased approximately 79% to $35.8 million, primarily driven by an increase in costs related to market research studies and pre-launch activities in preparation for the commercial launch of DefenCath, and an increase in personnel expenses as a result of additional hires in 2023. These increases were partially offset, among others of lesser significance, by a decrease in legal fees for the period.

SG&A 費用增加約 79%，達到 3580 萬美元，主要是由於為 DefenCath 的商業推出做準備而進行的市場研究和啟動前活動相關的成本增加，以及 2023 年額外聘用人員導致的人員費用增加。這些增長被該期間法律費用的減少部分抵消，其中其他影響較小。

We recorded net cash used in operations during 2023 of $38.4 million compared with net cash used in operations of $24.4 million in 2022. The increase is primarily driven by an increase in net loss primarily attributable to an increase in operating expenses as compared with the same period in 2022.

我們記錄的 2023 年營運中使用的淨現金為 3,840 萬美元，而 2022 年營運中使用的淨現金為 2,440 萬美元。這一增長主要是由於與 2022 年同期相比營運費用增加導致淨虧損增加。

CorMedix remains in a good position from a balance sheet perspective as we prepare the company for a commercial launch of DefenCath in April. The company had cash and cash equivalents of $76 million as of December 31, 2023. As we have discussed previously, we expect our operating expenses, especially SG&A to increase in 2024, given the growth of the company and the costs driven by the commercial launch of DefenCath.

從資產負債表的角度來看，CorMedix 仍處於有利地位，因為我們正在為四月 DefenCath 的商業推出做準備。截至2023年12月31日，該公司擁有現金及現金等價物為7,600萬美元。正如我們之前所討論的，考慮到公司的成長以及 DefenCath 商業推出所帶來的成本，我們預計 2024 年的營運支出，尤其是 SG&A 將增加。

CorMedix anticipates 2024 quarterly operating expenses to range from around $15 million to $18 million to support commercial infrastructure and the launch of DefenCath. We believe our cash, cash equivalents, short-term investments and projected future operating cash flow gives the company the ability to fund operations for at least 12 months and to fund the commercial launch of DefenCath through to anticipated profitability, which may occur on a run rate basis by the end of December 2024, assuming we are able to achieve our internal base case assumptions for DefenCath demand, uptake, net pricing and reimbursement.

CorMedix 預計 2024 年季度營運費用約為 1,500 萬美元至 1,800 萬美元，以支援商業基礎設施和 DefenCath 的推出。我們相信，我們的現金、現金等價物、短期投資和預計的未來營運現金流使公司有能力為至少12 個月的營運提供資金，並為DefenCath 的商業啟動提供資金，直至達到預期的盈利能力（這可能會在運行過程中發生）假設我們能夠實現 DefenCath 需求、使用量、淨定價和報銷的內部基本情況假設，則到 2024 年 12 月底之前的費率基礎。

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，讓他發表結束語。喬？

Thanks, Matt. CorMedix is laser focused on our upcoming launch date in April. We’ve actively engaged in customer discussions on both the in-patient and out-patient settings of care and are optimistic about our launch potential for 2024 and beyond.

謝謝，馬特。CorMedix 高度關注我們即將在四月推出的日期。我們積極參與客戶關於住院和門診護理環境的討論，並對 2024 年及以後的推出潛力持樂觀態度。

With respect to any future potential indications for DefenCath, we are targeting the submission of a post-approval meeting request to FDA by the end of March and we expect to have a meaningful discussion with FDA around potential clinical pathways in mid-year 2024.

關於 DefenCath 未來的任何潛在適應症，我們的目標是在 3 月底之前向 FDA 提交批准後會議請求，並預計在 2024 年年中與 FDA 圍繞潛在的臨床路徑進行有意義的討論。

As I mentioned earlier, we do not intend to provide revenue or earnings guidance at this time. However, we may revisit guidance if and when appropriate.

正如我之前提到的，我們目前不打算提供收入或獲利指導。但是，我們可能會在適當的時候重新審視指南。

I appreciate everyone’s continued support in CorMedix, and I am 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 Instructions)

（操作員說明）

Jason Butler, Citizen's JMP.

Jason Butler，公民 JMP。

Hi, thanks for taking the questions, and congrats on the progress.

您好，感謝您提出問題，並祝賀您的進展。

Just wondering if you could give us a little bit more detail on the progress you’re making with the hospital P&T committees. Do you have meetings scheduled at this point, and do you think you can get any -- when do you think you can get the first decisions out of those meetings?

只是想知道您是否可以向我們詳細介紹一下您與醫院 P&T 委員會的進展。您現在是否安排了會議？您認為您可以獲得任何會議 - 您認為您什麼時候可以從這些會議中做出第一個決定？

And then secondly, just walk us through how we should think about the early launch and utilization within the hospitals as you get these committee meetings and approvals? I mean, should we expect any use before you get the first committee approvals? Thanks.

其次，請告訴我們，當您獲得這些委員會會議和批准時，我們應該如何考慮醫院內的早期啟動和利用？我的意思是，在獲得第一屆委員會批准之前我們是否應該期待任何用途？謝謝。

Yes, thanks Jason. So from a P&T meeting process, we do have some meetings that are currently scheduled. We have a number that we expect to be scheduled, let’s say in the second quarter. I don't -- I can’t really comment on the timing of how quickly that will move and whether they will adopted on formulary, but the way I would think about in-patient, and I’ll even touch on out-patient for a second, we mentioned it would be a slower ramp due to the P&T process.

是的，謝謝傑森。因此，從 P&T 會議流程來看，我們目前確實安排了一些會議。我們預計會安排一個數字，比如說在第二季。我不——我無法真正評論這一舉措的實施時間以及是否會在處方中採用，但我會考慮住院病人的方式，我什至會談到-請耐心等待，我們提到由於P&T 過程，斜坡將會變慢。

So when we think about it in the short term and long term, we think about the in-patient side as kind of a more steady, gradual ramp, whereas on the out-patient side, given the potential size of certain large customers as well as even the ability of a mid-sized customer to move volume, we would expect that ramp to be a little more lumpy, right?

因此，當我們從短期和長期角度考慮時，我們認為住院方面是一種更穩定、漸進的增長，而在門診方面，考慮到某些大客戶的潛在規模即使是中型客戶移動數量的能力，我們也預計該成長會更加不穩定，對吧？

And on the out-patient side, we see maybe new patient starts within those facilities focusing initially on fee-for-service patients, right, as then we begin to onboard and [make plans] over time to be a little bit kind of in step, right, more of a lumpy upward ramp.

在門診方面，我們看到可能會有新患者在這些設施中開始，最初專注於收費服務患者，對吧，然後我們開始入職並隨著時間的推移[制定計劃]右邊的台階，更像是一個崎嶇不平的向上斜坡。

Got it. And then, just one more from me, in terms of the label expansion activities, other catheter use settings. Obviously, you mentioned waiting for the FDA interactions and feedback, but just from an operational perspective, are you guys preparing to be in a position to launch those trials or start those trials quickly after you get FDA alignment?

知道了。然後，我再補充一點，關於標籤擴展活動和其他導管使用設定。顯然，您提到等待 FDA 的互動和回饋，但僅從操作角度來看，您是否準備好啟動這些試驗或在獲得 FDA 協調後迅速啟動這些試驗？

Obviously, they’d have to depend on whether or not they adopt the proposal that we intend to make, right? If they are accepting of the pathway that we’re going to put forward for certain expanded indications, we can launch those fairly quickly, it’s not immediate, right, not just flipping on a light switch, but if they desire for more work to be done, then it could be a longer pathway.

顯然，他們必須取決於他們是否採納我們打算提出的提案，對吧？如果他們接受我們為某些擴展適應症提出的途徑，我們可以相當快地啟動這些途徑，這不是立即的，對吧，不僅僅是打開電燈開關，但如果他們想要還有更多的工作要做，那麼這條路可能會更長。

Okay, great. Thanks for taking the questions.

好的，太好了。感謝您提出問題。

Gregory Renza, RBC Capital Markets.

格雷戈里·倫扎（Gregory Renza），加拿大皇家銀行資本市場部。

Hi, Joe and team, it’s Anish on for Greg. Congrats on the progress this quarter, and thanks for taking my questions. Just first, maybe if you could give us an update on the current composition of your commercial field force and for some granularity on the new adds in the in-patient and outpatient segments to date. And then secondly, how are you thinking about current and upcoming shifts in political tides affecting CMS reimbursement policies as it pertains to DefenCath? Thanks again.

嗨，喬和團隊，阿尼什替補格雷格。恭喜本季的進展，並感謝您回答我的問題。首先，也許您可以向我們提供有關您的商業現場人員當前構成的最新信息，以及迄今為止住院和門診部分新增人員的一些詳細信息。其次，您如何看待當前和即將到來的影響 CMS 報銷政策（與 DefenCath 相關）的政治趨勢變化？再次感謝。

Thanks, Anish. So from a field team standpoint, we’ve migrated a little bit from, I think, our thinking last year, and rather than have a bifurcation between the in-patient and out-patient teams, we somewhat melded them into one with geographic deployment being more important than, let’s say, a split between those two settings of care.

謝謝，安尼什。因此，從現場團隊的角度來看，我認為我們去年的想法有所轉變，我們沒有將住院團隊和門診團隊分開，而是將它們合併為一個具有地理區域的團隊。部署比這兩種護理環境之間的劃分更重要。

Given the nature of the role is more of a key account manager than a medical rep, it’s essentially the same skill set on both sides of the care from a reimbursement knowledge, from a contracting standpoint, the hurdle on both sides really is getting the product adopted in the system, be it a large system or a small dialysis operator.

鑑於該角色的性質更多的是大客戶經理而不是醫療代表，從報銷知識和簽約的角度來看，護理雙方基本上具有相同的技能，雙方的障礙確實是讓產品在系統中採用，無論是大型系統還是小型透析操作員。

So right now, we’re staffed with about 30 in the field. We think that’s sufficient for launch. We may look to grow over time into the 45-50 range, but right now we’re comfortable where we’re at, that we have the right team in place.

目前，我們在該領域擁有約 30 名員工。我們認為這足以啟動。隨著時間的推移，我們可能會擴大到 45-50 人的範圍，但現在我們對目前的情況感到滿意，因為我們擁有合適的團隊。

From a political standpoint, it’s really hard to tell what may happen. Certainly, we have four years of experience with the Biden White House and have just gone through our experience with CMS. We also have four years of past experience with the Trump administration. So at this time, we’re not really seeing anything drastically change at CMS, regardless of who ends up in the White House, but certainly it could always change.

從政治角度來看，很難預測會發生什麼事。當然，我們在拜登白宮有四年的經驗，並且剛經歷過 CMS 的經驗。我們過去也有四年與川普政府打交道的經驗。因此，目前，無論誰最終入主白宮，我們並沒有真正看到 CMS 發生任何巨大變化，但它肯定總是會發生變化。

Great. Thank you.

偉大的。謝謝。

Les Sulewski, Truist Securities.

Les Sulewski，Truist 證券公司。

Good morning, thank you for taking my questions. Can you, Joe, provide some color on distribution channels, around your commercial inventory levels ahead of launch, and how do you expect in-patient centers to manage their stocking levels and maybe your implied ratio on expected demand for the 3 ml versus the 5 ml vial? Also a follow-up to that, which quarter would you expect the manufacturing costs to shift from R&D to [COGS]?

早上好，謝謝您回答我的問題。喬，您能否提供一些有關分銷渠道、發布前的商業庫存水平的信息，以及您期望住院中心如何管理其庫存水平，以及您對 3 毫升與 5 毫升的預期需求的隱含比率毫升小瓶？另外，您預計哪個季度的製造成本將從研發轉移到[銷貨成本]？

Thanks, Les, good questions. So from a distribution channel standpoint, essentially, the end inventory is going to flow through specialty distribution. On the in-patient side -- or for in-patient facilities, it will flow through a specialty distributor. On the out-patient side, it will be a mix of going through specialty distributor for some customers and others potentially will go -- will get shipped direct.

謝謝，萊斯，好問題。因此，從分銷管道的角度來看，本質上，最終庫存將透過專業分銷管道流動。在住院患者方面，或對於住院設施，它將透過專業經銷商進行流通。在門診方面，部分客戶將透過專業經銷商進行銷售，而其他客戶則可能會直接出貨。

On the 3 ml and 5 ml issue, the 5 ml is in our label because we had done additional development work. Remember, the product was initially in a 5 ml vial, but it’s not our intent to commercialize the 5 ml at this time, so we’re launching -- the intent is to launch the product with the 3 ml.

關於 3 毫升和 5 毫升的問題，5 毫昇在我們的標籤中，因為我們做了額外的開發工作。請記住，該產品最初裝在 5 毫升小瓶中，但我們目前無意將 5 毫升瓶裝商業化，因此我們推出的目的是推出 3 毫升瓶裝的產品。

The last question that you asked, about when we cut over, it’s a difficult one, right, because it depends on uptake and demand. I think the faster demand goes, you could certainly see cut over earlier, right, this year., right? If demand is a little bit slower, it may take some more time. So we’ve built a decent amount of inventory pre -- that was expensed, right, prior to approval.

你問的最後一個問題，關於我們何時切換，這是一個困難的問題，對吧，因為這取決於吸收和需求。我認為需求成長得越快，你肯定會看到更早的削減，對吧，今年。，對嗎？如果需求慢一點，可能需要更多時間。因此，我們已經建立了相當數量的庫存，在批准之前就已經支出了。

Got it. Thanks.

知道了。謝謝。

Did I touch on everything or it was --

我是否觸及了一切，或者它是--

I think you did, yes. Just one more follow-up, I guess on the strategy around separate payment under Medicare Part B reimbursement. What are some potential timelines for filing an approval that you expect on this, and the potential impact to your WAC price?

我想你做到了，是的。我想還有一個後續行動，是關於 Medicare B 部分報銷項下單獨付款的策略。您預計提交批准的潛在時間表是什麼，以及對您的 WAC 價格的潛在影響？

Yes, I’m not sure I thought of that question, Les. So we have our out-patient reimbursement determination. CMS has made a determination that we’re eligible for TDAPA, right, that it’s going to fall under the scope of the end stage of the ESRD prospective payment system. On the in-patient side, we do have our NTAP. So the J-code application is required for TDAPA, right? So J-code, if that’s what you might be thinking, is separate from a Part B determination.

是的，我不確定我是否想到過這個問題，萊斯。這樣我們就有了門診報銷的決定。CMS 已確定我們有資格獲得 TDAPA，對吧，它將屬於 ESRD 預期支付系統末期的範圍。在住院病人方面，我們確實有 NTAP。那麼 TDAPA 需要 J 代碼申請，對嗎？因此，J 代碼（如果您可能這麼想的話）與 B 部分的確定是分開的。

Does that clarify the question at all, L

這是否澄清了問題，L

Correct, and is there potential for any adjustments to the WAC price?

正確，WAC 價格是否有可能調整？

So look, we’d launch the product with a WAC of $249. I don’t at this time envision any adjustments to the WAC price during the TDAPA period, but we will always re-evaluate as we move forward.

那麼，我們推出的產品的 WAC 為 249 美元。我目前不打算在 TDAPA 期間對 WAC 價格進行任何調整，但隨著我們的進展，我們將始終重新評估。

Got it, thank you.

收到了。謝謝。

Serge Belanger, Needham & Company.

謝爾蓋貝蘭格 (Serge Belanger)，李約瑟公司。

Hi, good morning. Thanks for taking my questions. Joe, I think you mentioned that the P&T review process would take three to nine months. Maybe just talk a little bit about that process and what it entails.

早安.感謝您回答我的問題。Joe，我想您提到過 P&T 審核過程需要三到九個月的時間。也許只是談談這個過程及其需要的內容。

And then in the out-patient setting, do you also expect an adoption process or evaluation process before there is uptake? And maybe lastly, if you can walk us through your base case for breakeven by the end of the year? Thanks.

然後在門診環境中，您是否也期望在採用之前進行採用過程或評估過程？也許最後，您能否向我們介紹一下您在年底前達到損益平衡的基本情況？謝謝。

Okay, so I’m going to start with number three first and then I’m going to -- I’ll allow Erin to comment on the P&T process for facilities. And certainly outpatient, I think that was what you were asking in your second question, outpatient, they follow a similar evaluation process for making a determination to put a product on formulary and into utilization, right?

好的，我將首先從第三點開始，然後我將允許 Erin 對設施的 P&T 流程發表評論。當然，門診患者，我認為這就是您在第二個問題中所問的問題，門診患者，他們遵循類似的評估流程來決定將產品列入處方並投入使用，對嗎？

They’re looking at the clinical data for the product, they’re looking at the medical need and certainly the reimbursement to the facility, as well as whatever economic terms that we’re able to provide that institution. So from -- I think what you’re asking in number three is are -- can you clarify, are you asking me to confirm that we get to run rate? What was your question on three?

他們正在研究產品的臨床數據，他們正在研究醫療需求，當然還有對機構的報銷，以及我們能夠為該機構提供的任何經濟條件。因此，我想您在第三個問題中要問的是，您能否澄清一下，您是在要求我確認我們是否達到了運行速度嗎？你問的三是什麼？

Really, just the pushes and pulls to get you to that breakeven status that you talked about as your base case.

實際上，只需推動和拉動即可使您達到您所說的基本情況的盈虧平衡狀態。

Okay. Yes, sure. So -- I mean, look, we have certain assumptions we’ve made for demand and uptake on both the in-patient and out-patient side, right? That produces a revenue forecast internally and a cash flow forecast that we are comfortable with, gets us to run rate breakeven profitability, as I mentioned.

好的。是的，當然。所以，我的意思是，我們對住院和門診的需求和吸收率做出了某些假設，對嗎？正如我所提到的，這會產生我們滿意的內部收入預測和現金流量預測，使我們能夠實現損益平衡的獲利能力。

So I don’t think we’re going to provide more granularity than that at this time, where as I said, we’re not going to give revenue guidance, but certainly I think you can do the math. We’ve given guidance on what our run rate operating expenses are going to be. So you can somewhat back into where revenue really needs to be in order to hit that milestone.

因此，我認為我們目前不會提供比這更多的粒度，正如我所說，我們不會提供收入指導，但我認為你當然可以計算一下。我們已經就運行費用的運行費用給出了指導。因此，您可以稍微回顧一下收入真正需要達到的水平才能達到該里程碑。

So Erin, you want to provide a --

所以艾琳，你想提供一個--

Sure, I can provide a little bit of color around the P&T process. The process itself is driven by the hospital internally, right? So usually, you have a physician champion that advocates for the product and then the formulary meeting happens and they adopt the product, and then it goes through the process of implementing it within the health system. We’ve seen a lot of interest in the product, both organically and inorganically, right, where we’ve done some reach outs and we’ve also had reach outs from hospitals to us.

當然，我可以為 P&T 流程提供一些色彩。這個過程本身是由醫院內部驅動的，對嗎？因此，通常情況下，你會有一位醫生擁護者來倡導該產品，然後召開處方會議，他們採用該產品，然後在衛生系統中經歷實施該產品的過程。我們看到人們對該產品有很多興趣，無論是有機的還是無機的，對吧，我們已經做了一些接觸，也有醫院向我們伸出了援手。

I think the benefit here is that we have secured the NTAP prior to being approved. We have that opportunity to leverage a payment mechanism on the in-patient side, and we also have the opportunity to leverage the health economics, right, the long-term complications of these patients. The hospitals are the ones that see those patients and those expenses. So we’ve had a lot of organic and inorganic interest from the hospitals.

我認為這樣做的好處是我們在獲得批准之前就已經獲得了 NTAP。我們有機會利用住院病患的支付機制，我們也有機會利用健康經濟學，對的，這些病患的長期併發症。醫院負責收治這些病人並承擔這些費用。因此，醫院對我們有很多有機和無機的興趣。

Thanks Erin. Serge, does that answer your questions?

謝謝艾琳。塞爾吉，這能回答你的問題嗎？

Yes. Thank you.

是的。謝謝。

Thank you. I’ll now turn the call back over to Dan Ferry for written questions from the audience.

謝謝。現在我將把電話轉回給丹費裡（Dan Ferry），讓觀眾提出書面問題。

Thank you, operator. Joe, we have few written-in questions from the audience here. The first one is your NTAP was approved based on an estimated WAC price of $1,170 per vial. However, you have launched the product with an actual WAC of about $250 per vial. Can you explain what impact this will have on the NTAP reimbursement? Do you expect this price point to have a positive or negative impact on in-patient utilization, and further, what color can you provide around why the lower WAC was decided?

謝謝你，接線生。喬，我們這裡的觀眾提出的書面問題很少。第一個是您的 NTAP 獲得批准是基於每瓶 1,170 美元的 WAC 預估價格。然而，您推出的產品的實際 WAC 約為每瓶 250 美元。您能否解釋一下這將對 NTAP 報銷產生什麼影響？您預計這個價格點會對住院病患的使用率產生正面還是負面的影響？此外，您能提供什麼顏色來說明為何決定降低 WAC？

Okay. Thanks, Dan. There’s a lot to unpack there. I’m going to start with taking a step back and the thought process around when we established the $1,170 price point. When we filed the NTAP application two years ago, the market landscape looked very different, specifically on the out-patient side, right? TDAPA was two years, we didn’t necessarily have visibility to out-patient utilization, and we did our market analysis and market research around where the product would need to be priced on the in-patient side alone for the size of the in-patient market. And ultimately, we settled on the $1,170 price.

好的。謝謝，丹。那裡有很多東西需要解開。我將首先退一步思考我們確定 1,170 美元價格點時的思考過程。當我們兩年前提交 NTAP 申請時，市場模式看起來非常不同，特別是在門診方面，對嗎？TDAPA 是兩年，我們不一定了解門診患者的使用情況，我們圍繞產品需要僅在住院患者方面根據住院患者的規模進行定價進行了市場分析和市場研究。- 病患市場。最終我們確定了 1,170 美元的價格。

Since that time, obviously the landscape has shifted. TDAPA is now five years, we’ve had a number of conversations with customers in both settings of care over the last two years, and on the out-patient side specifically have gotten much more comfortable and confident around the ability to, first of all, secure reimbursement with TDAPA, and second, get sufficient uptake.

從那時起，情況顯然發生了變化。TDAPA 已經五年了，在過去的兩年裡，我們在兩種護理環境中與客戶進行了多次對話，特別是在門診方面，我們對以下能力感到更加放心和自信：首先，確保獲得TDAPA 報銷，其次，獲得足夠的吸收。

So the WAC price that we established of $249.99 really was driven by the dynamics of TDAPA for the out-patient segment, but is a reasonable price point for in-patient.

因此，我們確定的 249.99 美元的 WAC 價格實際上是由門診患者 TDAPA 的動態驅動的，但對於住院患者來說是一個合理的價格點。

So one of the other key pieces of feedback we took over the last two years from in-patient institutions, as we messaged around the NTAP and the value of the NTAP, was from many institutions that they perceived lower acquisition cost of product to be preferred to a higher NTAP reimbursement.

因此，當我們圍繞 NTAP 和 NTAP 的價值傳達訊息時，我們在過去兩年中從住院機構收到的其他關鍵反饋之一是來自許多機構，他們認為較低的產品採購成本是首選以獲得更高的NTAP 報銷。

So to that extent, the feedback we’ve gotten in the in-patient side is that the lower WAC price is more favorable. So I think to the question you asked about do you expect this price point to have a positive or a negative impact on utilization, the feedback we’re getting is that the lower acquisition cost of product should drive higher utilization on the in-patient side. So certainly, we’re happy with that.

所以從這個意義上來說，我們在住院方面得到的回饋是WAC價格越低越優惠。因此，我認為，對於您提出的問題，您預計這個價格點會對利用率產生積極還是消極影響，我們得到的反饋是，較低的產品採購成本應該會提高住院患者的利用率。當然，我們對此感到滿意。

Okay, great. Thanks Joe. A second question here is are there any expected studies or data to be presented over the coming months, and can you give an investors a sense of which conferences CorMedix may have a presence?

好的，太好了。謝謝喬。第二個問題是，未來幾個月是否會出現任何預期的研究或數據，您能否讓投資人了解 CorMedix 可能會參加哪些會議？

Yes, thanks. I’m going to turn that over to Liz in a moment, but we’ve got a pretty ambitious 2024 planned with both field organizations being out there and active in a number of industry conferences.

對了謝謝。我稍後會將其轉交給 Liz，但我們已經制定了一個相當雄心勃勃的 2024 年計劃，兩個現場組織都在現場並積極參與許多行業會議。

Liz, why don’t you go ahead?

麗茲，你為什麼不繼續呢？

Sure. Thanks, Joe. Yes, we’re excited, actually, we’re going to be presenting two abstracts this spring at the upcoming Society for Healthcare Epidemiology of America, or SHEA’s annual meeting, and both field teams, both medical and commercial are going to be present at over a dozen conferences this year and continuing to connect with key stakeholders. So those include SHEA, MAD-ID, the NKIF spring conference, Renal Physicians Association. So I think we have a really good presence out there.

當然。謝謝，喬。是的，我們很興奮，事實上，我們將在今年春天即將召開的美國醫療保健流行病學協會（SHEA）年會上展示兩份摘要，並且兩個現場團隊，無論是醫療團隊還是商業團隊，都今年將出席十多次會議，並繼續與主要利害關係人保持聯繫。這些包括 SHEA、MAD-ID、NKIF 春季會議、腎臟醫師協會。所以我認為我們在這方面的表現非常好。

Okay great. Thanks, Liz. Thanks, Joe.

好的，太好了。謝謝，莉茲。謝謝，喬。

Joe. final question here is, can you give a sense of what investors may be missing? What is key to understanding CorMedix over the near term?

喬.最後一個問題是，您能否說明投資人可能缺少什麼？近期了解 CorMedix 的關鍵是什麼？

Okay. Thanks, Dan. So -- look, I assume you’re thinking about it from a stock price trading standpoint. I still think we’re a story that’s not completely widely understood, right? We are in a very nichey therapeutic segment with an atypical reimbursement and a lot of acronyms we talk about, NTAP, TDAPA, that are not necessarily common vernacular for biotech investors.

好的。謝謝，丹。所以——聽著，我假設你是從股價交易的角度來考慮這個問題的。我仍然認為我們的故事還沒有被廣泛理解，對吧？我們處於一個非常小眾的治療領域，報銷非典型，我們談論的許多縮寫詞，NTAP，TDAPA，這些對於生物技術投資者來說不一定是常見的術語。

We’re also a young biotech going through its first launch. So I think historically a lot of investors have kind of sat on the sidelines waiting for new -- perhaps a new equity offering. But as we’ve discussed today, we’re focused on launch. We think there’s a lot of launch value to DefenCath that is certainly not captured in the trading value of the stock, and we also think that there’s potentially long-term value.

我們也是一家年輕的生物技術公司，正在經歷首次推出。因此，我認為從歷史上看，許多投資者都在觀望，等待新的——也許是新的股票發行。但正如我們今天所討論的，我們的重點是發布。我們認為 DefenCath 有很大的啟動價值，而這些價值肯定沒有體現在股票的交易價值中，而且我們也認為存在潛在的長期價值。

We have 10.5 years of exclusivity, we’re expecting to meet with FDA mid-year around a label expansion for DefenCath, but I think more importantly, over the next couple of years, our expectation is to be developing real world evidence demonstrating that the impact that DefenCath can have on infection rates and on patients. And certainly, we’d look to utilize that real world data as, one, we obviously establish broader utilization but also more long-term reimbursement across the continuum of care.

我們擁有10.5 年的獨家經營權，我們預計將在年中與FDA 就DefenCath 的標籤擴展進行會面，但我認為更重要的是，在接下來的幾年裡，我們的期望是開發真實世界的證據來證明DefenCath 對感染率和患者的影響。當然，我們希望利用這些現實世界的數據，因為，第一，我們顯然在整個護理過程中建立了更廣泛的利用，也建立了更長期的報銷。

Okay, great. Thanks, Joe. Operator, that concludes the written portion of the Q&A session. You may now close the call.

好的，太好了。謝謝，喬。操作員，結束問答環節的書面部分。您現在可以結束通話了。

Thank you. Ladies and gentlemen, this concludes your conference call for today. We thank you for participating and ask that you please disconnect your lines. Have a lovely day.

謝謝。女士們、先生們，今天的電話會議到此結束。我們感謝您的參與，並請您斷開線路。祝你愉快。