CorMedix Inc (CRMD) 2023 Q3 法說會逐字稿

Good afternoon, and welcome to CorMedix third-quarter 2023 earnings conference call. Today's call is being recorded. (Operator Instructions)

下午好，歡迎參加 CorMedix 2023 年第三季財報電話會議。今天的通話正在錄音。 （操作員說明）

At this time, I would like to turn the conference over to Dan Ferry from LifeSci Advisors. Please go ahead.

這次，我想將會議轉交給 LifeSci Advisors 的 Dan Ferry。請繼續。

Good afternoon, and welcome to the CorMedix third-quarter 2023 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; Dr. Phoebe Mounts, EVP and General Counsel; and Erin Mistry, EVP and Chief Commercial Officer.

下午好，歡迎參加 CorMedix 2023 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 Todisco；執行副總裁兼財務長 Matt David 博士也加入其中； Phoebe Mounts 博士，執行副總裁兼總法律顧問；和艾琳·米斯特里（Erin Mistry），執行副總裁兼首席商務官。

Before we begin, I would like to remind everyone that during the call, management may make what are known as forward-looking statements within the meaning set forth in the Private Securities Litigation Reform Act of 1995. These statements are subject to certain risks and uncertainties that 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 clinical development program, manufacturing activities, and marketing approval for DefenCath in the US or for other product candidates; future financial position; future revenues and projected costs; and reimbursement and potential market acceptance of DefenCath or other product candidates.

在開始之前，我想提醒大家，在電話會議期間，管理階層可能會做出 1995 年《私人證券訴訟改革法案》規定的所謂前瞻性陳述。這些陳述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（包括其臨床開發計劃、製造活動和營銷批准）的歷史事實陳述之外的任何陳述美國的 DefenCath 或其他候選產品；未來的財務狀況；未來收入和預計成本； DefenCath 或其他候選產品的報銷和潛在市場接受度。

More specifically, forward-looking statements include any statements about our clinical development plans and the timing, cost, progress, results, estimates, and interpretations thereof; projections as to the company's future capital raising and spending in cash position, including projections regarding the sufficiency of the company's current cash resources to potentially bring the company through to breakeven profitability, expectations as to the timing and nature of anticipated regulatory actions, reimbursement decisions, possible product licensing, business development or other transactions; any commercial plans and expectations, intellectual property protections for our product candidates, market projections for our product candidates and expectations as to manufacturing, and product component costs.

更具體地說，前瞻性陳述包括有關我們的臨床開發計劃及其時間、成本、進展、結果、估計和解釋的任何陳述；對公司未來融資和現金支出的預測，包括對公司當前現金資源是否足以使公司實現盈虧平衡盈利的預測、對預期監管行動的時間和性質的預期、報銷決定、可能的產品許可、業務開發或其他交易；任何商業計劃和期望、我們候選產品的智慧財產權保護、我們候選產品的市場預測以及對製造和產品組件成本的期望。

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 filings with the SEC, including the latest quarterly report on Form 10-Q and the 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.

由於多種重要因素，實際結果可能與這些預測或估計有重大差異。包括但不限於與臨床開發、監管審批和商業化相關的不確定性。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 網站 www.sec 上免費獲取。 . gov 或根據CorMedix 的要求。

CorMedix may not actually achieve the goals or plans described in these forward-looking statements, and investors should not place undue reliance on these statements. Please note that 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描述的目標或計劃，投資者不應過度依賴這些陳述。請注意，除非法律要求，否則 CorMedix 不打算更新這些前瞻性聲明。

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.

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 afternoon, everyone, and thank you for joining us.

謝謝，丹。大家下午好，感謝您加入我們。

As we approach tomorrow's target action date for DefenCath, I am very pleased with the progress that the company has made toward pursuing final NDA approval from FDA, as well as preparations for commercialization. I'm happy to announce that the FDA completed a preapproval inspection for our finished dosage CDMO site in September. We are very pleased with the outcome and an Establishment Inspection Report or EIR is expected to be issued imminently.

隨著 DefenCath 明天的目標行動日期臨近，我對該公司在尋求 FDA 最終 NDA 批准以及商業化準備方面所取得的進展感到非常高興。我很高興地宣布 FDA 於 9 月完成了我們成品劑量 CDMO 站點的預先批准檢查。我們對結果非常滿意，預計將立即發布企業檢查報告或 EIR。

I'd like to thank and congratulate all of the CorMedix employees who have worked diligently with our CDMO and external consultants in preparation for the inspection, as well as thank our CDMO, ROVI Pharma Industrial Services, for their commitment to CorMedix and DefenCath. Phoebe will provide additional clarity around preapproval inspections and the status of the NDA review process.

我要感謝並祝賀所有與我們的 CDMO 和外部顧問一起辛勤工作以準備檢查的 CorMedix 員工，並感謝我們的 CDMO、ROVI Pharma Industrial Services 對 CorMedix 和 DefenCath 的承諾。 Phoebe 將提供有關預先批准檢查和 NDA 審查流程狀態的更多說明。

Certainly, it's frustrating for us to host this call today, a day ahead of our PDUFA date, but this was the last day we could conduct this call under SEC requirements, and we were hopeful that FDA could potentially take action earlier than our target action date. FDA has communicated to CorMedix that they are working towards taking action on our application tomorrow. And at present time, the company is not aware of any outstanding review items or deficiencies that would lead to a negative outcome.

當然，今天比我們的PDUFA 日期提前一天召開這次電話會議對我們來說是令人沮喪的，但這是我們根據SEC 的要求進行這次電話會議的最後一天，我們希望FDA 可能比我們的目標行動更早採取行動日期。 FDA 已與 CorMedix 溝通，他們正在努力明天對我們的申請採取行動。目前，該公司不知道任何未完成的審查項目或缺陷會導致負面結果。

In that regard, in advance of our target action date, we have intensified our preparations for commercial launch with a number of key new hires in market access, sales training, pricing and contracting, commercial operations, field medical, and drug safety and pharmacovigilance. We are building a significant number of capabilities in-house, as well as relying on external vendors for certain activities that require larger scale.

在這方面，在我們的目標行動日期之前，我們已經加強了商業啟動的準備工作，在市場准入、銷售培訓、定價和承包、商業運營、現場醫療以及藥物安全和藥物警戒方面聘請了一些關鍵的新員工。我們正在內部建立大量功能，並依賴外部供應商來進行某些需要更大規模的活動。

Our inpatient field team will consist of a combination of in-house market access key account managers, as well as external expert advisers with deep relationships at specific high-value target institutions and health systems. In the event we do receive final FDA approval over the coming days, we are targeting a commercial launch before the end of the first quarter of 2024, likely initially focused on the inpatient segment only.

我們的住院現場團隊將由內部市場准入大客戶經理以及與特定高價值目標機構和衛生系統有深厚關係的外部專家顧問組成。如果我們在未來幾天內獲得 FDA 的最終批准，我們的目標是在 2024 年第一季末之前進行商業發布，最初可能只專注於住院患者領域。

Our assumptions around commercial launch and sales ramp may be impacted by external factors. Most notably, the timing of reimbursement guidance from the Center for Medicare and Medicaid Services, or CMS, around outpatient reimbursement for DefenCath.

我們對商業發布和銷售成長的假設可能會受到外部因素的影響。最值得注意的是，醫療保險和醫療補助服務中心 (CMS) 圍繞 DefenCath 門診報銷提供報銷指導的時間安排。

Over the past two months, we have been engaged in an active back-and-forth discussion with CMS, making our case that DefenCath should be properly reimbursed as an outpatient drug product under Medicare Part B. We have provided the government with significant legal, commercial, and health economic rationale in support of DefenCath obtaining separate payment.

在過去的兩個月裡，我們與 CMS 進行了積極的反覆討論，提出了 DefenCath 應該作為 Medicare B 部分下的門診藥品得到適當報銷的理由。我們已向政府提供了重要的法律、支持DefenCath 獲得單獨付款的商業和健康經濟理由。

The alternative to separate payment under Medicare Part B would be a CMS determination that DefenCath is a renal dialysis service, ineligible for a transitional drug add-on payment or TDAPA. While we maintain our guidance to analysts and investors to consider TDAPA as our base case from a financial modeling standpoint, the company feels strongly that the DefenCath does not fall within the current statutory definition of a renal dialysis service, and therefore, should properly be separately reimbursed under Medicare Part B.

根據 Medicare B 部分單獨付款的替代方案是 CMS 確定 DefenCath 是腎臟透析服務，沒有資格獲得過渡藥物附加付款或 TDAPA。雖然我們維持對分析師和投資者的指導，從財務模型的角度將 TDAPA 視為我們的基本案例，但該公司強烈認為 DefenCath 不屬於腎透析服務的現行法定定義範圍，因此應適當分開根據Medicare B部分報銷。

CorMedix is preparing to submit an application to CMS for a unique product J-code on January 1, 2024, for Part-B reimbursement, provided our NDA receives FDA approval. The deadline from CMS to submit an application for TDAPA is also on January 1. Absent direct feedback from CMS advising the company to submit an application for TDAPA prior to that January deadline, CorMedix does not intend to submit an application at this time as we do not believe that the product is a renal dialysis service.

CorMedix 正準備於 2024 年 1 月 1 日向 CMS 提交獨特產品 J 代碼的申請，以用於 B 部分報銷，前提是我們的 NDA 獲得 FDA 批准。 CMS 提交 TDAPA 申請的截止日期也是 1 月 1 日。如果 CMS 沒有直接回饋建議公司在 1 月截止日期之前提交 TDAPA 申請，CorMedix 不打算像我們一樣此時提交申請切勿相信該產品是腎透析服務。

As TDAPA is a quarterly application process with a full quarter to implement, should CMS deemed DefenCath to be a renal dialysis service, our TDAPA application will, therefore, lag any such determination and may impact the timing of outpatient product launched by a quarter. It is also worth noting that a prolonged government shutdown could adversely impact the timing of any guidance from CMS around reimbursement and the submission review of either a J-code or TDAPA application.

由於 TDAPA 是季度申請流程，需要整個季度實施，如果 CMS 認為 DefenCath 是腎臟透析服務，我們的 TDAPA 申請將落後於任何此類決定，並可能影響門診產品在一個季度推出的時間。還值得注意的是，政府長期關閉可能會對 CMS 就報銷和 J 代碼或 TDAPA 申請提交審查提供任何指導的時間產生不利影響。

With respect to a potential inpatient launch in the first quarter of 2024, we contemplate this would be a soft launch as we can only begin the process of seeking P&T formulary approval at various health systems, once the NDA for DefenCath has final FDA approval. Over the past several months, we have accelerated the process of building relationships with key target health systems, identifying key opinion leaders, and engaging external advisers that have existing relationships with those targeted systems.

關於 2024 年第一季潛在住院患者的推出，我們認為這將是一次軟啟動，因為只有在 DefenCath 的 NDA 獲得 FDA 最終批准後，我們才能開始在各個衛生系統尋求 P&T 處方批准的過程。在過去的幾個月裡，我們加快了與關鍵目標衛生系統建立關係的進程，確定了關鍵意見領袖，並聘請了與這些目標系統有現有關係的外部顧問。

The P&T process varies but can take anywhere from three to nine months depending on the health system. We are hopeful to be able to land some quick early formulary positions. However, the ramp on the inpatient side is expected to be slow over the first three to nine months of launch.

P&T 流程各不相同，但可能需要三到九個月的時間，具體取決於衛生系統。我們希望能夠快速獲得一些早期的處方職位。然而，預計在推出後的前三到九個月內，住院患者的成長將緩慢。

At present time, due to the inpatient formulary lag and the expected timing to implement any outpatient reimbursement, we would not expect meaningful revenue contributions until the second half of 2024. Provided we obtain timely NDA approval, we anticipate discussing more granularity around inpatient launch ramp and the timing of outpatient launch during our year-end earnings call.

目前，由於住院患者處方的滯後性以及實施任何門診報銷的預期時間，我們預計要到2024 年下半年才能產生有意義的收入貢獻。如果我們及時獲得新藥申請(NDA) 批准，我們預計將圍繞住院患者啟動斜坡進行更詳細的討論以及我們年終財報電話會議期間門診啟動的時間。

I will now turn the call over to Phoebe for a regulatory update and discuss progress toward potential FDA approval. Phoebe?

我現在將把電話轉給菲比，詢問最新監管情況，並討論 FDA 批准的進展。菲比？

Thanks, Joe. Good afternoon, everyone.

謝謝，喬。大家下午好。

I would like to thank and congratulate everyone on the teams who have worked so hard towards preparation of the CDMO site for a preapproval inspection, as well as in responding to all other requests by FDA for information on the DefenCath NDA resubmission.

我要感謝並祝賀團隊中的每個人，他們為 CDMO 網站的批准前檢查做好準備，以及響應 FDA 提供有關 DefenCath NDA 重新提交信息的所有其他請求而付出了巨大的努力。

In addition to a preapproval inspection of our primary finished dosage manufacturing site, the FDA has also conducted preapproval inspections for DefenCath as suppliers of active pharmaceutical ingredients contract laboratories involved in testing of product specifications and packaging facilities. We are not aware of any outstanding review issues at this time.

除了對我們的主要成品製劑生產基地進行預先批准檢查外，FDA 還對 DefenCath 作為參與產品規格和包裝設施測試的活性藥物成分合約實驗室供應商進行了預先批准檢查。目前我們尚未發現任何未解決的審核問題。

Over the past several months, we have received multiple requests for information from FDA, related to the content of the DefenCath NDA including draft prescribing information, which is consistent with the normal NDA review process. Most recently, we received a request for updated secondary packaging labels, as well as a request for information related to our post-approval pediatric study commitment.

在過去的幾個月裡，我們收到了 FDA 的多起索取資訊的請求，涉及 DefenCath NDA 的內容，包括處方資訊草案，這與正常的 NDA 審查流程一致。最近，我們收到了更新二級包裝標籤的請求，以及與我們批准後兒科研究承諾相關的資訊的請求。

You may recall that CorMedix and FDA agreed to a post-marketing commitment to conduct a study in pediatric hemodialysis patients pursuant to PREA or Pediatric Research Equity Act and BPCA or Best Pharmaceuticals for Children Act. When this study is completed, it will have the potential to extend 6 months of marketing exclusivity to the five years of marketing exclusivity for potential approval of DefenCath as a new chemical entity or NCE, and the additional five years for the designation of DefenCath as a qualified infectious disease product.

您可能還記得，CorMedix 和 FDA 同意做出上市後承諾，根據 PREA（兒科研究公平法）和 BPCA（兒童最佳藥物法）對兒科血液透析患者進行研究。這項研究完成後，將有可能將6 個月的行銷獨佔期延長至5 年的行銷獨佔期，以便DefenCath 可能被批准為新化學實體或NCE，並有可能將DefenCath 指定為額外的5 年行銷獨佔期。合格的傳染病產品。

We view these requests as positive indicators that our NDA review is progressing in line with our expectations. We have also received written notification from FDA that the proprietary name DefenCath remains conditionally acceptable, pending final approval of the NDA by FDA.

我們認為這些請求是積極的指標，表明我們的 NDA 審查進展符合我們的預期。我們也收到 FDA 的書面通知，表示專有名稱 DefenCath 仍然有條件地可接受，等待 FDA 最終批准 NDA。

Lastly, we made the decision to proactively retail to FDA and withdraw from our application our original supplier of heparin API. You may recall from our prior communications that during our Type A meeting in April, the FDA had advised us to resubmit the NDA with two suppliers of heparin API, as our initial supplier had an ongoing warning letter unrelated to heparin.

最後，我們決定主動向 FDA 零售，並退出我們原來的肝素 API 供應商的申請。您可能還記得我們先前的溝通中，在 4 月的 A 類會議上，FDA 建議我們與兩家肝素 API 供應商重新提交 NDA，因為我們最初的供應商持續發出與肝素無關的警告信。

FDA advised during our Type A meeting that should the warning letter remain unresolved as we approach our target action date, we would have the ability to withdraw that source as a supplier from the application. As of late September, that warning letter remained unresolved. And though our supplier has implemented corrective actions, no closeout inspection has yet been scheduled by FDA. To that extent, we made the decision to withdraw that supplier of heparin API from our NDA application so as not to unnecessarily delay our eligibility for final NDA approval.

FDA 在我們的 A 類會議上建議，如果在我們接近目標行動日期時警告信仍未解決，我們將有能力從申請中撤回該來源作為供應商。截至9月底，該警告信仍未解決。儘管我們的供應商已採取糾正措施，但 FDA 尚未安排收尾檢查。就此而言，我們決定從我們的 NDA 申請中撤回該肝素 API 供應商，以免不必要地延遲我們獲得最終 NDA 批准的資格。

We will reevaluate resubmitting the heparin supplier following clearance of the warning letter and the potential FDA approval of the DefenCath NDA. We now optimistically anticipate FDA action with tomorrow's target action date. It is worth emphasizing that the PDUFA date is a target action date and not a statutory requirement. FDA is not required to take action by the action date and there are recent instances of FDA taking action on days preceding or following a specific target date.

在警告信獲得批准以及 DefenCath NDA 可能獲得 FDA 批准後，我們將重新評估重新提交肝素供應商的情況。我們現在樂觀地預期 FDA 會在明天的目標行動日期採取行動。值得強調的是，PDUFA 日期是目標行動日期，而不是法定要求。 FDA 不需要在行動日期之前採取行動，並且最近有 FDA 在特定目標日期之前或之後採取行動的實例。

As noted by Joe, FDA has communicated that the NDA remains under review and the agency is working towards taking action by the PDUFA date. We are unaware of any outstanding information that is required.

正如 Joe 所指出的，FDA 已表示 NDA 仍在審查中，該機構正在努力在 PDUFA 日期之前採取行動。我們不知道需要任何未完成的資訊。

I would now like to turn the call over to Matt, who will provide a financial update. Matt?

我現在想把電話轉給馬特，他將提供最新的財務資訊。馬特？

Thanks, Phoebe, and good afternoon, everyone. I am pleased to be here today to provide an overview of our third-quarter and year-to-date 2023 financial results as well as an update on CorMedix' cash position. The company has filed its quarterly report on Form 10-Q for the quarter ended September 30, 2023. I urge you to read the information contained in the report for a more complete discussion of our financial results.

謝謝菲比，大家下午好。我很高興今天來到這裡，概述我們的 2023 年第三季和年初至今的財務業績以及 CorMedix 現金狀況的最新情況。該公司已提交截至 2023 年 9 月 30 日的季度 10-Q 表格季度報告。我強烈建議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。

With respect to our third quarter of 2023 financial results, our net loss was approximately $9.7 million or $0.17 per share, compared with a loss of $6.9 million or $0.17 per share in the third quarter of 2022. The higher net loss recognized in 2023 compared with 2022 included an increase in operating expenses driven by prelaunch activities for DefenCath versus the third quarter of 2022.

就我們2023 年第三季的財務業績而言，我們的淨虧損約為970 萬美元或每股0.17 美元，而2022 年第三季的虧損為690 萬美元或每股0.17 美元。2023 年確認的淨虧損高於與 2022 年第三季相比，2022 年 DefenCath 的啟動前活動導致營運費用增加。

Operating expenses in the third quarter of 2023 increased approximately 50% to $10.5 million, compared with $7 million in the third quarter of 2022. R&D expense increased by approximately 14% to $2.7 million, driven primarily by an increase in costs related to medical affairs activities and an increase in personnel expenses.

2023 年第三季的營運費用成長約50%，達到1,050 萬美元，而2022 年第三季營運費用為700 萬美元。研發費用成長約14%，達到270 萬美元，主要是由於與醫療事務活動相關的成本增加以及人員費用的增加。

SG&A expense increased approximately 69% to $7.8 million in the third quarter of 2023, compared with $4.6 million in the third quarter of 2022. This increase was primarily attributable to an increase in costs related to market research studies and prelaunch activities in preparation for the potential marketing approval of DefenCath, and an increase in personnel expenses due to additional hires, partially offset by a decrease in legal fees for the period.

2023 年第三季的銷售、管理及行政費用增加約69%，達到780 萬美元，而2022 年第三季為460 萬美元。這一增長主要歸因於與市場研究和為潛在市場做準備的與啟動前活動相關的成本增加。 DefenCath 的營銷批准，以及由於額外僱用而導致的人員費用增加，但部分被該期間法律費用的減少所抵消。

With respect to our nine-month year-to-date 2023 financial results, total operating expenses during the nine months year-to-date of 2023 amounted to $33.3 million compared with $22.3 million in the first nine months of 2022, an increase of 49%. R&D expense increased 39% to $10.9 million, driven primarily by an increase in personnel expenses and 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 potential marketing approval.

就我們 2023 年迄今 9 個月的財務表現而言，2023 年至今 9 個月的總營運費用為 3,330 萬美元，而 2022 年前 9 個月為 2,230 萬美元，增加了 49 倍。% 。研發費用增加了 39%，達到 1,090 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 DefenCath 潛在上市批准之前製造的技術和品質運營相關的成本增加。

SG&A expense increased approximately 55% to $22.4 million compared with the first nine months of 2022, primarily driven by an increase in costs related to market research studies and prelaunch activities in preparation for the potential marketing approval of DefenCath, an increase in personnel expenses and an increase in noncash charges for stock-based compensation. These increases were partially offset by a decrease in legal fees for the period.

與 2022 年前 9 個月相比，SG&A 費用增加約 55%，達到 2,240 萬美元，主要是由於與市場研究和為 DefenCath 潛在行銷批准做準備的上市前活動相關的成本增加、人員費用增加以及股票薪酬的非現金費用增加。這些增長被該期間法律費用的減少部分抵消。

We recorded net cash used in operations during the nine months year-to-date of 2023 of $27.7 million, compared with net cash used in operations of $18.2 million in the same period in 2022. The increase is primarily driven by an increase in net loss primarily attributable to an increase in operating expenses as compared to the same period in 2022. With the closing of our announced equity offering earlier in the third quarter, CorMedix is in a strong position from a balance sheet perspective as we prepare the company for a potential commercial launch in the first quarter of 2024.

2023 年至今的 9 個月，我們的營運所用現金淨額為 2,770 萬美元，而 2022 年同期營運所用現金淨額為 1,820 萬美元。這一增長主要是由於淨虧損增加所致主要是由於營運費用與2022 年同期相比有所增加。隨著我們在第三季早些時候宣布的股票發行結束，從資產負債表的角度來看，CorMedix 處於有利地位，因為我們為公司的潛在發展做好了準備將於 2024 年第一季投入商業營運。

The company has cash and cash equivalents of $86.6 million as of September 30, 2023. We believe our cash, cash equivalents, short-term investments, and other available resources gives the company the capability to fund the commercial launch of DefenCath through to anticipated profitability, assuming we are able to obtain timely approval of the DefenCath NDA on our action date and commence commercial launch in the first quarter of 2024 as well as achieve other internal base case assumptions.

截至2023 年9 月30 日，該公司擁有現金和現金等價物8660 萬美元。我們相信，我們的現金、現金等價物、短期投資和其他可用資源使公司有能力為DefenCath 的商業啟動提供資金，直至實現預期獲利，假設我們能夠在行動日期及時獲得 DefenCath NDA 的批准，並在 2024 年第一季度開始商業發布，並實現其他內部基本情況假設。

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 keenly focused on our upcoming target action date and hoping for a positive outcome from FDA. We are firing on all cylinders, preparing for a potential commercial launch. We have the inventory manufactured and ready to be labeled once we have a final label from FDA. And we have new batches scheduled from our CDMO.

謝謝，馬特。 CorMedix 密切關注我們即將到來的目標行動日期，並希望 FDA 能取得正面成果。我們正在全力以赴，為潛在的商業發布做準備。一旦我們獲得 FDA 的最終標籤，我們就會製造庫存並準備好貼上標籤。我們的 CDMO 已安排了新批次。

We are actively in communications with CMS. And once the determination is made regarding our reimbursement structure, we will pivot our launch strategy accordingly. As I mentioned earlier, I do expect to be able to provide more granularity around launch assumptions on our next earnings call.

我們正在積極與 CMS 進行溝通。一旦確定了我們的報銷結構，我們將相應地調整我們的發布策略。正如我之前提到的，我確實希望能夠在下一次財報電話會議上提供有關發布假設的更詳細資訊。

I appreciate everyone's continued support in CorMedix. 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。

Thank you. And ladies and gentlemen, we will now begin the question-and-answer session. (Operator Instructions) Jason Butler, JMP Securities.

謝謝。女士們、先生們，我們現在開始問答環節。 （操作指示）Jason Butler，JMP 證券。

Thanks for taking the questions and congrats on all of the progress to date. And obviously, we're excitedly waiting for the decision from FDA. Couple of questions. You mentioned that you've had some label discussions or negotiations with FDA. The label or the draft label that you're aware of today, consistent with your expectations? And do you think it gives you an optimal launch opportunity?

感謝您提出問題，並對迄今為止的所有進展表示祝賀。顯然，我們正在興奮地等待 FDA 的決定。有幾個問題。您提到您已經與 FDA 進行了一些標籤討論或談判。您今天所了解的廠牌或廠牌草稿是否符合您的預期？您認為這是否為您提供了最佳的發布機會？

And then, understanding that a full commercial launch will happen in 1Q, how soon will the product be commercially available? And can you give us any color on, A, the steps that you'll take from now until commercial -- full commercial launch? And how we should think about capacity, especially from the API supplier during the first parts of the launch? Thanks.

然後，了解到將在第一季全面商業發布，該產品將在多長時間內上市？您能否告訴我們從現在到商業化（全面商業化）之前您將採取的步驟？我們應該如何考慮容量，尤其是在發布的第一階段來自 API 供應商的容量？謝謝。

All right. Thank you, Jason. I think the first question is easy to address on the label. There were no surprises in anything that we've seen in our communications from FDA, so we're certainly happy with the feedback that we've seen on the label. And as you point out, we're not guiding toward a full commercial launch in the first quarter.

好的。謝謝你，傑森。我認為第一個問題很容易在標籤上解決。我們在 FDA 的通訊中看到的任何內容都沒有令人驚訝，因此我們對標籤上看到的回饋當然感到滿意。正如您所指出的，我們並沒有指導在第一季進行全面的商業發布。

And certainly, there are some decision points we might have to make that could cause us to want to maybe push out a couple of weeks around reimbursement, right? We want to maximize the value of whatever reimbursement structure that we get, and we're very conscious of ASP management.

當然，我們可能必須做出一些決定，這可能會導致我們想要將報銷時間推遲幾週，對吧？我們希望最大限度地提高我們獲得的任何報銷結構的價值，並且我們非常關注 ASP 管理。

But we're targeting right now, having the product available for inpatient launch by the end of the first quarter of 2024. Capacity, we -- as I said, we have CDMO capacity reserved for batches early in the year. We can certainly scale that up toward the back part of the year as we get toward our outpatient -- kicking off our outpatient launch, but we've also already placed purchase orders for API, so API capacity should not be a constraint on launch in the back part of the year.

但我們現在的目標是，在 2024 年第一季末將該產品用於住院患者。產能方面，正如我所說，我們為今年年初的批次預留了 CDMO 產能。我們當然可以在今年下半年擴大規模，因為我們的門診即將啟動，但我們也已經下了 API 的採購訂單，因此 API 容量不應成為 2020 年推出的限制。今年的後半部分。

Great. And just last one on the outpatient reimbursement. Any insights into the dialogue with CMS at this point? Do you feel like -- have you got any responses from them that indicate that you're making progress towards securing approval under Medicare Part D?

偉大的。還有門診報銷的最後一項。目前對與 CMS 的對話有什麼見解嗎？您是否覺得——您是否收到了他們的任何回复，表明您在獲得 Medicare D 部分的批准方面正在取得進展？

It's Part B not Part D. But look, I think it's been a productive back-and-forth discussion. I think we continue to guide that our base case for investors should be TDAPA. We think TDAPA is perfectly adequate reimbursement structure for end-stage renal disease or renal dialysis services. We just don't think that DefenCath falls within the scope of renal dialysis service.

這是 B 部分，而不是 D 部分。但看，我認為這是一次富有成效的反覆討論。我認為我們將繼續指導投資者的基本情況應該是 TDAPA。我們認為 TDAPA 對於末期腎病或腎透析服務是完全足夠的報銷結構。我們只是認為 DefenCath 不屬於腎臟透析服務的範圍。

So all I'll say is that we think it's been productive. We think we've provided the government with compelling HEOR and patient market data. And we're hopeful that CMS would make a determination or give us guidance before the end of the year. There's certainly no timing that they're bound by, but they are aware that there's a deadline for a J-code and a TDAPA application on Jan 1 as we are. And we're hopeful that, barring a long-term government shutdown, that we could get some direction from them before the end of the year.

所以我想說的是，我們認為這是富有成效的。我們認為我們已經向政府提供了令人信服的 HEOR 和患者市場數據。我們希望 CMS 能在年底前做出決定或給我們指導。當然，他們沒有時間限制，但他們知道 J 代碼和 TDAPA 申請的截止日期是 1 月 1 日，就像我們一樣。我們希望，除非政府長期關閉，否則我們可以在年底前從他們那裡得到一些指示。

Great. Thanks for taking the questions.

偉大的。感謝您提出問題。

Thanks.

謝謝。

Joon Lee, Truist Securities.

李俊，Truist 證券公司。

Hi, guys. This is Les on for Joon. I just want to echo that congrats on the progress, looking forward to tomorrow. Just to clear up, you'll be submitting the application for the outpatient side for J-code, assuming Jan 1. Is there a possibility for you to resubmit if not approved for the first time? And what's the timeline look like on that? And I have a follow up.

嗨，大家好。這是 Les on for Joon。我只想回應，祝賀取得的進展，期待明天。澄清一下，假設1月1日，您將向門診提交J代碼申請。如果第一次未獲批准，您是否可以重新提交？時間表是怎樣的？我有一個後續行動。

Both. I think what you're asking, though, Les, is if we submit the application and we don't have a determination from CMS on the reimbursement structure, is that what you're asking?

兩個都。不過，Les，我認為您要問的是，如果我們提交了申請，而 CMS 沒有就報銷結構做出決定，這就是您要問的嗎？

Yes.

是的。

Well, certainly, look, if we submit the application, and then subsequently, CMS guides us that they believe TDAPA is the appropriate structure, we'd have to reevaluate what discussions we would have with them around continuing to pursue separate payment, but I likely would not forgo the opportunity to submit a TDAPA application and start that process.

好吧，當然，看，如果我們提交申請，然後 CMS 指導我們，他們認為 TDAPA 是合適的結構，我們必須重新評估我們將與他們圍繞繼續尋求單獨付款進行哪些討論，但我很可能不會放棄提交TDAPA 申請並啟動該流程的機會。

Okay. Thanks for that. And you did mention that there's a lingering potential government shutdown. I mean we -- very unknown, but in the unlikely scenario that does happen, how does that impact any of your commercial launch, if at all? And then, also, where are you standing in engagement with way of P&T meetings, and what have been your prelaunch activities thus far? Thank you.

好的。感謝那。你確實提到政府關閉的可能性揮之不去。我的意思是我們——非常未知，但在不太可能發生的情況下，這會如何影響您的任何商業發布（如果有的話）？另外，您對 P&T 會議方式的參與程度如何？到目前為止，您的啟動前活動是什麼？謝謝。

All right. Well, look, as I mentioned in the script, to the extent there was a long-term shutdown that prevented CMS from giving us reimbursement guidance or reviewing either a TDAPA or J-code application, certainly, that could impact the timing of commercial launch. In order for products to get utilization, they need adequate reimbursement and that needs to be established whether it's for inpatient health systems or outpatient dialysis facilities.

好的。好吧，正如我在腳本中提到的，在某種程度上，長期關閉導致 CMS 無法向我們提供報銷指導或審查 TDAPA 或 J 代碼應用程序，這當然可能會影響商業發布的時間。為了使產品得到利用，它們需要足夠的報銷，並且無論是住院醫療系統還是門診透析設施，都需要建立此報銷。

In terms of prelaunch activities, we've been quite active, right? We've had a number of discussions with various health systems, with the LDOs around how potentially different reimbursement structures could fit into their system. So we're preparing for various ultimate scenarios and getting ready for commercialization.

在發布前的活動方面，我們一直很活躍，對吧？我們與各個衛生系統以及 LDO 就如何將不同的報銷結構融入其係統進行了多次討論。所以我們正在為各種終極場景做準備，為商業化做好準備。

Les, did we lose you? Operator, can we move to the next question, please?

萊斯，我們失去你了嗎？接線員，我們可以進入下一個問題嗎？

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。

Forward to the decision coming soon. Maybe just --

期待即將做出的決定。也許只是——

Hi, Greg, can you start over? Can you start over? We didn't hear the first part of what you're saying.

嗨，格雷格，你能重新開始嗎？你能重新開始嗎？我們沒有聽到你所說的第一部分。

Yeah. Just adding my congrats on the progress, Joe.

是的。我只是對所取得的進展表示祝賀，喬。

Thanks.

謝謝。

And I just mentioned that we're looking forward to tomorrow or the decision coming up. And maybe, Joe, just my question, maybe to build on some of your mention of the potential government shutdown. I just wanted to ask if you're considering certainly on the eve of a potential decision or approval, any other macro factors that are part of your consideration in the strategy to really roll out DefenCath?

我剛剛提到我們期待明天或即將做出的決定。喬，也許這只是我的問題，也許是基於您提到的政府可能關閉的問題。我只是想問一下，在潛在決定或批准前夕，您是否正在考慮在真正推出 DefenCath 的策略中考慮的任何其他宏觀因素？

And it's helpful to hear about the government proceedings, but also, if it comes to the labor and the hires and even some of the stakeholder engagement, to what extent are you now considering it now that we're at the doorstep of a potential approval here? And then, I have a follow up.

了解政府程序是有幫助的，而且，如果涉及到勞動力和僱用，甚至一些利益相關者的參與，現在我們正處於潛在批准的門口，您現在在多大程度上考慮它這裡？然後，我有一個後續行動。

Look, as I -- thanks, Greg, and I appreciate the congratulations. And as I somewhat mentioned in the prepared comments, we've been ramping up and accelerating over the past couple of months. I'd say since we got visibility of the inspection, you've likely seen us posting a number of hires, adding new roles, continuing our engagement with key stakeholders.

看，我——謝謝，格雷格，我很感激你的祝賀。正如我在準備好的評論中提到的那樣，在過去的幾個月裡，我們一直在加速。我想說，自從我們了解了檢查情況後，您可能會看到我們招募了一些員工，增加了新的職位，並繼續與關鍵利益相關者接觸。

So the government shutdown, if it happens, it will be unfortunate. I think we were talking today about the longest shutdown that's happened is only several weeks. So we don't think that it's going to be, overall, devastating, but hopefully, it can be minimized by the government and nothing more than a blip if it does happen at all. But we're just focused on operational execution right now. Assuming a positive -- we get a positive outcome from FDA tomorrow, we're doing everything we need to be doing to execute on our launch plan.

所以政府關門，如果發生的話，那將是不幸的。我想我們今天討論的是最長的關閉時間只有幾週。因此，我們認為總體而言，這不會是毀滅性的，但希望政府可以將其最小化，如果真的發生的話，也只不過是曇花一現。但我們現在只專注於營運執行。假設明天我們從 FDA 得到積極的結果，我們正在盡一切努力來執行我們的上市計劃。

Yeah, that's great. Very helpful. Maybe, just one quick one. Just coming back to the clinical value proposition, and also, the ability for DefenCath to really be the first approved product in this area. Just remind us of that value proposition, really what the landscape looks like when it comes to infection prevention. And I'm just curious how you think about the practice and care standard variability out there and how this could be a solution in the space? Thanks so much and congrats. Looking forward to tomorrow.

是的，那太好了。很有幫助。也許，只是快一點。回到臨床價值主張，以及 DefenCath 真正成為該領域第一個獲得批准的產品的能力。只是提醒我們這個價值主張，即感染預防的實際情況。我只是好奇您如何看待實踐和護理標準的可變性，以及這如何成為該領域的解決方案？非常感謝並祝賀。期待明天。

Sure thing. Thanks, Greg. I appreciate it. Certainly, our Phase-3 clinical results demonstrated in our primary endpoint, a 71% reduction with risk associated with CRBSI for hemodialysis patients with a CVC. There is nothing currently FDA approved, the drug product for the prevention of CRBSI in this patient population or in any patient population for that matter, so this truly is a first-in-class therapy.

當然可以。謝謝，格雷格。我很感激。當然，我們的 3 期臨床結果證明，我們的主要終點是 CVC 血液透析患者的 CRBSI 相關風險降低了 71%。目前 FDA 還沒有批准任何用於在該患者群體或任何患者群體中預防 CRBSI 的藥物產品，因此這確實是一種一流的療法。

As you point out, we were looking to change the paradigm from one where infections are treated after the fact, right? You have a disease state with an incredibly high incidence rate, we've got upwards of a third of hemodialysis patients with a catheter will get a CRBSI. Half of those infections happen in the first 90 days that they have a catheter, so they happen fast, they happen frequently, and they're fatal 25% of the time. So I would say that this is absolutely a critical unmet medical need. And we're looking forward to providing this option for prescribers and physicians and health systems for their patients.

正如您所指出的，我們希望改變事後治療感染的模式，對吧？您患有一種發病率極高的疾病，我們有超過三分之一的使用導管的血液透析患者會患上 CRBSI。其中一半的感染發生在使用導管後的前 90 天內，因此發生速度快、發生頻率高，且 25% 的情況是致命的。所以我想說這絕對是一個關鍵的未滿足的醫療需求。我們期待為處方者和醫生以及患者的衛生系統提供這種選擇。

That's great. Thanks again.

那太棒了。再次感謝。

Thank you. And at this time, I would like to turn it back to Dan Ferry from LifeSci Advisors for additional written questions from the audience.

謝謝。此時，我想將其轉回 LifeSci Advisors 的 Dan Ferry，以徵求觀眾提出的其他書面問題。

Thank you, operator. Joe, we have a few here from the audience that was -- were written in here. The first one is, you mentioned that the company is pleased with the outcome of the PAI, preauthorized -- preapproval inspections. Can you elaborate what is meant by that?

謝謝你，接線生。喬，我們這裡有一些觀眾寫的。第一個是，您提到公司對 PAI 預授權預核准檢查的結果感到滿意。能詳細說明一下這是什麼意思嗎？

Yeah. Thanks, Dan. And I assume that's directed at the preapproval inspection for the -- for our primary CDMO, which we've announced is ROVI. Yeah, so typically, when an inspection concludes, it takes about 90 days for an EIR issue, and we're still waiting on that EIR. But we're very happy with the way the inspection progressed. At the close of the inspection, the inspector verbally communicated that she'd be recommending voluntary action indicated status.

是的。謝謝，丹。我認為這是針對我們的主要 CDMO 的預先批准檢查，我們已經宣布它是 ROVI。是的，通常情況下，當檢查結束時，EIR 問題需要大約 90 天的時間，而我們仍在等待該 EIR。但我們對檢查的進展感到非常滿意。檢查結束時，檢查員口頭表示她將建議採取自願行動指示狀態。

And if you're familiar, it means that it will allow -- new approvals can proceed from that facility. Also, I'd say, over the last couple of days, our manufacturing partner, ROVI, recently announced that another sponsor received approval of an application of a registration from the same facility where we intend to make DefenCath. So from a compliance standpoint, that gives us a lot of comfort.

如果您熟悉的話，這意味著它將允許——新的批准可以從該設施進行。另外，我想說的是，在過去的幾天裡，我們的製造合作夥伴 ROVI 最近宣布，另一家贊助商收到了我們打算製造 DefenCath 的同一工廠的註冊申請批准。因此，從合規的角度來看，這給了我們很大的安慰。

Okay. Great, Joe. Just a few more here. You described during the call, a potential launch in Q1 2024. Can you give some color regarding, one, what investors can expect to see some revenue? Two, what metrics CorMedix intends to report related to the launch in the form of maybe hospitals or patients? Can you give us some color here?

好的。太棒了，喬。這裡還有一些。您在電話會議中描述了可能在 2024 年第一季推出的產品。您能否說明一下，投資者可以期望看到哪些收入？第二，CorMedix 打算以醫院或病患的形式報告與發布相關的哪些指標？你能給我們一些顏色嗎？

Sure. Thanks, Dan. So right, as we mentioned, we're expecting a soft launch in the early part of the year that we would look to certainly accelerate as we get our outpatient reimbursement solidified, whether it's TDAPA or a separate payment. We would expect to give some directional revenue guidance, hopefully, on our next earnings call, should -- provided we have a reimbursement determination from CMS.

當然。謝謝，丹。所以，正如我們所提到的，我們預計會在今年年初進行軟啟動，隨著我們的門診報銷得到鞏固，無論是 TDAPA 還是單獨付款，我們肯定會加速這一過程。我們希望在下一次財報電話會議上給出一些定向收入指導，前提是我們有 CMS 的報銷決定。

But along the way, I think there's going to be catalysts that certainly we can talk about and report, whether it's certain health systems formulary status, potentially agreements with LDOs or MDOs that where we could point to directional revenue guidance and value. And all of that could certainly be over the upcoming months.

但在此過程中，我認為肯定會有一些催化劑，我們當然可以討論和報告，無論是某些衛生系統的處方狀態，還是與LDO 或MDO 的潛在協議，我們可以在其中指出定向收入指導和價值。所有這一切肯定會在接下來的幾個月裡發生。

Excellent. Thanks Joe. One final one here. It's a good segue. What do you view as some of the key catalysts going into 2024 for CorMedix?

出色的。謝謝喬。最後一張在這裡。這是一個很好的延續。您認為 CorMedix 進入 2024 年的一些關鍵催化劑是什麼？

Yes. So obviously, I touched on some of them. The first and foremost is approval. We have to lock down NDA approval, hopefully, tomorrow. Beyond that, we're waiting on a decision from CMS around the reimbursement structure for DefenCath.

是的。顯然，我觸及了其中的一些。首先也是最重要的是批准。我們必須鎖定 NDA 批准，希望是明天。除此之外，我們正在等待 CMS 關於 DefenCath 報銷結構的決定。

That will guide how we roll out our launch strategy in inpatient and outpatient. But some of those key catalysts that I just mentioned, potential agreements with LDOs or MDOs, updates around larger health systems, P&T and formulary adoption. And potentially, later next year, updating on label expansion for DefenCath into additional indications.

這將指導我們如何在住院和門診中推出我們的啟動策略。但我剛才提到的一些關鍵催化劑、與 LDO 或 MDO 的潛在協議、圍繞更大的衛生系統、P&T 和處方採用的更新。明年晚些時候，DefenCath 的標籤擴展可能會更新為其他適應症。

Excellent. Thank you, Joe. Operator, you may now close the call.

出色的。謝謝你，喬。接線員，您現在可以結束通話了。

Thank you, presenters. And ladies and gentlemen, this concludes today's conference call. Thank you for participating. You may now disconnect.

謝謝各位主持人。女士們、先生們，今天的電話會議到此結束。感謝您的參與。您現在可以斷開連線。